Abdominoperineal Resection

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Abdominoperineal Resection

Description

  • abdominoperineal resection (APR) is a radical resection of the rectum that generally encompasses stoma creation after lower anterior resection with total mesorectal excision (TME) and includes perianal resection(4,5)

Also Called

  • abdominoperineal excision
  • abdominal perineal resection

Definitions

  • total mesorectal excision (TME)(1,2)
    • generally recommended surgical technique for resection of rectal cancer (ESMO Grade A, Level III for meticulous excision of mesorectal fat, including all lymph nodes)
      • involves en bloc removal of mesorectum, including associated vascular and lymphatic structures, fatty tissue, and mesorectal fascia as a “tumor package” through sharp dissection, but designed to spare autonomic nerves
      • optimally part of anterior resection or abdominoperineal resection (APR), depending on tumor location relative to the anal verge
      • References – Ann Oncol 2017 Jul 1;28(suppl_4):iv22
  • circumferential margin (or circumferential resection margin [CRM])(2)
    • closest radial distance (in mm) within the specimen between the deepest penetration of the tumor and the outside margin of the resected soft tissue around the rectum or the outside edge of the lymph node tissue
    • includes the subperitoneal or retroperitoneal aspects of the tumor
    • considered involved or threatened CRM if tumor or lymph node tissue is within 1 mm of the resected margin
  • low anterior resection (LAR) is used instead of APR for tumors > 5 cm from the anal verge(2,3,4)
    • abdominal resection following principles of TME, dividing the visceral and parietal layers of the endopelvic fascia
    • resection may extend up to 5 cm beyond the tumor
      • reports of extent vary, but National Comprehensive Cancer Network (NCCN) guidelines report that the treatment of choice for patients with lesions in the mid-to-upper rectum includes:
        • LAR extending 4-5 cm below the distal edge of the tumor using TME
        • creation of a colorectal anastomosis

Types

  • abdominoperineal resection (APR) may be classified by the extent of tissue resection required to optimize oncologic outcomes(4,5)
    • CLINICIANS’ PRACTICE POINT: The options below represent increasingly radical resections, beginning with the highest but least common procedure (intersphincteric), the most commonly performed extrasphincteric APR, the extralevator (or ELAPE) procedure which has a wider margin, and the ischioanal procedure, which includes even more skin and soft tissue around the anus. The primary determinant of the resection type is the extent of disease involvement.
    • intersphincteric APR
      • uncommon APR involving resection between inner and outer sphincter, preserving exterior sphincter
      • primarily used for patients with inflammatory bowel disease, especially Crohn disease (Dis Colon Rectum 2015 Nov;58(11):1021)
      • indicated for patients with rectal cancer with tumor in ultralow position that
        • spares the sphincter complex, yet aims to remove mucosa, submucosa, and muscularis propria of the rectal wall
        • requires distal transection to obtain an appropriate distal margin of resection
    • extrasphincteric APR – (often termed “conventional” APR) involving resection of the entire sphincter
    • extralevator APR (ELAPR, or ELAPE; also called “cylindrical” APR in Colorectal Dis 2018 Sep;20 Suppl 5:5)
      • extrasphincteric resection that is widened laterally to the level of the levator ani complex insertion into the pelvic sidewall, yielding a more cylindrical specimen
        • part of the levator ani muscle is included in the excision en bloc with the rectum and anal canal
        • protects the most distal part of the bowel, avoiding the “waist” in the specimen which is typically seen after extrasphincteric APR
      • goals are to help avoid tumor violation and improve ability to obtain a negative circumferential margin and a microscopically negative (R0) resection
      • more tissue is removed and the perineal defect may be larger and more difficult to close
    • ischioanal APR (may also be referred to as “cylindrical” APR)
      • more radical resection than ELAPR (or ELAPE) that is widened beyond the external sphincter
      • includes ischioanal fat and/or skin areas for patients with tumors that cause perianal abscess or fistula, or who have tumors that protrude through the anus

Timing of Neoadjuvant Therapy

  • neoadjuvant therapy (NAT)(3)
  • timing has been reported associated with changes in local recurrence rates and adverse events(3)
    • preoperative NAT vs. postoperative adjuvant therapy; long-course chemoradiotherapy (LCCRT) treatment 4-6 weeks prior to APR compared with postoperative LCCRT reported associated with
      • reduced mean local recurrence at 5 years 6% vs. 13% (p < 0.01) and 10 years 7.1% vs. 10% (p < 0.05)
      • reduced rates of grade 3 or 4 adverse events 27% vs. 40% (p < 0.001)
      • reduced long-term adverse events 14% vs. 24% (p < 0.01)
      • no significant differences in 10-year overall survival, disease-free survival, or distant metastases
    • interval between NAT and resection is reported associated with the degree of pathologic complete response (pCR) and some surgical outcomes
      • interval of ≥ 8 weeks vs. < 8 weeks reported associated with higher pCR rate (relative risk 1.25, 95% CI 1.16-1.35)
      • pCR rates and downstaging reported to peak about 6-7 weeks following completion of short or long chemoradiotherapy
      • intervals > 11 weeks reported associated with increased postoperative morbidity and no additional downstaging

Preoperative Process and Patient Support

Preoperative Process

  •  assessment should be done by multidisciplinary team, including team coordinator, radiologists, surgeons, radiation oncologists, medical oncologists, and pathologists (ESMO Grade A, Level III; ASCRS Strong recommendation, Moderate-quality evidence)(1,3)
  • the preoperative process generally involves(1,2,3,4)
    • initial evaluation for patients with possibly resectable nonmetastatic rectal cancer including
      • complete history and physical examination
        • consider geriatric assessment or screening for frailty for patients > 70 years old (ESMO Grade C, Level III)
        •  palpation (digital rectal exam) for evaluating distance of tumor from anal verge, and for assessing sphincter infiltration
        •  ask all patients diagnosed with rectal cancer about family history and consider assessment for Lynch syndrome, familial adenomatous polyposis (FAP), and attenuated FAP (NCCN Category 2A)
        • performance status evaluation to help characterize patient and inform management
          • Karnofsky Performance Status (KPS) scale
            • total score range 0% (dead) to 100% (normal)

Table

Table 1: Karnofsky Performance Status Scale

DefinitionsRating (%)Criteria
Able to carry on normal activity; no special care needed100Normal; no complaints; no evidence of disease
90Able to carry on normal activity; minor signs or symptoms of disease
80Normal activity with effort; some signs or symptoms of disease
Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed70Cares for self; unable to carry on normal activity or do active work
60Requires occasional assistance but able to care for most personal needs
50Requires considerable assistance and frequent medical care
Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly40Disabled; requires special care and assistance
30Severely disabled; hospital admission indicated, although death not imminent
20Very sick; hospital admission necessary; active supportive treatment necessary
10Moribund; fatal processes progressing rapidly
0%Dead

Citation: Reference – J Gerontol 1991 Jul;46(4):M139, Cancer 1994 Apr 15;73(8):2087.

Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) Performance Status Scale

  • total score range 0 (fully active) to 5 (dead)

Table

Table 2: ECOG/WHO Performance Status Scale

GradeCriteria
0Fully active; able to carry on all predisease performance without restriction
1Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature (such as, light housework or office work)
2Ambulatory and capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours
3Capable of only limited self-care; confined to bed or chair > 50% of waking hours
4Completely disabled; cannot carry on any self-care; totally confined to bed or chair
5Dead

Citation: Abbreviations: ECOG, Eastern Cooperative Oncology Group; WHO, World Health Organization.Reference -Am J Clin Oncol 1982 Dec;5(6):649

    • biopsy for morphologic verification and review of pathology (NCCN Category 2A)
    • colonoscopy (NCCN Category 2A)
      • either preoperative colonoscopy or consider protoscopy (NCCN Category 2A)
      • CLINICIANS’ PRACTICE POINT: Preoperative colonoscopy to terminal ileum is typically performed, rectoscopy is an alternative if colonoscopy is not practical due to individual factors.
      •  if virtual colonoscopy not done, perform completion colonoscopy within 6 months of surgery (ESMO Grade A, Level III)
    •  complete blood count, chemistry profile, liver and renal function tests, and carcinoembryonic antigen (CEA) measurement (NCCN Category 2A; ESMO Grade A, Level III)
    • chest and abdominal computed tomography (CT) (NCCN Category 2A; ESMO Grade A, Level III)
      •  including IV and oral contrast agent
      •  if CT with IV contrast contraindicated, consider abdominal/pelvic magnetic resonance imaging (MRI) with contrast plus chest CT without contrast
    • local staging with MRI including
      • local invasion
      • mesorectal and extramesorectal lymph nodes
      • circumferential extension (resection margin)
      • sphincter involvement
      • pelvic MRI with contrast (preferred) or endorectal ultrasound (ERUS) (NCCN Category 2A)
        •  pelvic MRI most accurate for defining locoregional clinical staging; perform to guide preoperative management and define extent of surgery (ESMO Grade A, Level III)
        • ERUS may be most useful for early CT stages but is less useful for locally advanced disease
    • ERUS typically only used if MRI not feasible or in differentiating some T1 or T2 lesions (ASCRS Strong recommendation, Moderate-quality evidence)
    • see also SAGES preoperative assessment and preparation recommendations for laparoscopic resection of curable rectal cancer
    • Reference – Nat Rev Dis Primers 2015 Nov 5;1:15065full-text

Staging Systems

  • TNM classification is preferred staging system
  •  American Joint Committee on Cancer (AJCC) staging for colon and rectum cancer, eighth edition

Table

Table 3: Clinical Staging

StageTNM
0TisN0M0
IT1-T2N0M0
IIAT3N0M0
IIBT4aN0M0
IICT4bN0M0
IIIAT1-T2N1/N1cM0
T1N2aM0
IIIBT3-T4aN1/N1cM0
T2-T3N2aM0
T1-T2N2bM0
IIICT4aN2aM0
T3-T4aN2bM0
T4bN1-N2M0
IVAAny TAny NM1a
IVBAny TAny NM1b
IVCAny TAny NM1c
definitions of staging abbreviationsprimary tumor (T)TX – primary tumor cannot be assessed
T0 – no evidence of primary tumor
Tis – carcinoma in situ, intramucosal carcinoma (involvement of lamina propria with no extension through muscularis mucosae)
T1 – tumor invades submucosa (through muscularis mucosa but not into muscularis propria)
T2 – tumor invades muscularis propria
T3 – tumor invades through muscularis propria into pericolorectal tissues
 T4 – tumor invades visceral peritoneum or invades or adheres to adjacent organ or structureT4a – tumor invades through visceral peritoneum (including gross perforation of bowel through tumor and continuous invasion of tumor through areas of inflammation to surface of visceral peritoneum)
T4b – tumor directly invades or adheres to adjacent organs or structures
regional lymph nodes (N)NX – regional lymph nodes cannot be assessed
N0 – no regional lymph node metastasis
N1 – 1-3 positive (tumor in lymph nodes ≥ 0.2 mm) regional lymph nodes or presence of any number of tumor deposits, and all identifiable lymph nodes are negativeN1a – 1 positive regional lymph node
N1b – 2-3 positive regional lymph nodes
N1c – no positive regional lymph nodes, but tumor deposits in subserosa, mesentery, or nonperitonealized pericolic or perirectal/mesorectal tissues
N2 – ≥ 4 positive regional lymph nodesN2a – 4-6 positive regional lymph nodes
N2b – ≥ 7 positive regional lymph nodes
distant metastasis (M)M0 – no distant metastasis by imaging; no evidence of tumor in distant sites or organs (not assigned by pathologist)
M1 – metastasis to ≥ 1 distant site or organ or peritoneal metastasisM1a – metastasis to 1 site or organ with no peritoneal metastasis
M1b – metastasis to ≥ 2 sites or organs with no peritoneal metastasis
M1c – metastasis to peritoneal surface with or without other site or organ metastases
Used with permission of the American College of Surgeons, Chicago, Illinois. The original source for this information is the AJCC Cancer Staging Manual, Eighth Edition (2017) published by Springer International Publishing.

Indications
abdominoperineal resection (APR) is a radical resection that generally encompasses lower anterior resection with total mesorectal excision (TME), lymph node dissection, and perianal resection with resulting permanent colostomy (stoma) formation(4)about 40% of patients with rectal cancer will require treatment with APR
may be used to remove tumors within 5 cm from the anal verge along with involved pelvic structures and associated lymphoid tissue
indications includeultralow rectal tumors wherea negative distal margin cannot be obtained
tumor involves the levator ani complex and/or the external sphincter
may include patients with poor baseline sphincter function
therapy for anal cancerused between 10% and 30% of patients with anal squamous cell carcinoma, such as, whencancer has failed to respond to chemotherapy and/or radiation therapy
relapse after chemoradiotherapy
treatment-related intractable ulcers or fistulas affecting quality of life
Reference – Dtsch Arztebl Int 2015 Apr 3;112(14):243full-text
used for anal melanoma as an alternative to wide local excision (J Clin Aesthet Dermatol 2021 Apr;14(4):32)
patients with rectal dysplasia and inflammatory bowel disease not amenable to gastrointestinal continuity restoration
American Society of Colorectal Surgeons (ASCRS) guidance for curative resection indication is based on tumor location (ASCRS Strong recommendation, High-quality evidence)(3)tumors in the upper third of rectumas part of a low anterior resection (LAR) perform tumor-specific mesorectal excision
ideally divide mesorectum ≥ 5 cm below distal margin of the tumor
tumors in the middle and lower thirds of rectumas part of an ultralow anterior resection or APR, perform TME
for distal rectal cancers treated with TME, typically consider a 2-cm distal mural margin adequate
for cancers located at or below the mesorectal margin, consider a 1-cm distal mural margin generally acceptable
curative-intent resection of involved adjacent organs in patients with T4 rectal cancer should typically be performed en bloc (ASCRS Strong recommendation, Moderate-quality evidence)
for patients with an apparent complete clinical response to neoadjuvant therapy (ASCRS Strong recommendation, Moderate-quality evidence)(3)generally offer radical resection
for highly selected patients a “watch and wait” management approach in the context of a protocolized setting may be considered
APR may be classified according to how radical a resection is used, and the amount of resection is dictated by both preoperative imaging and intraoperative findings(3,4,5)extrasphincteric APR or conventional APR, involving resection of the entire sphincter; indications includeunable to achieve negative distal margin without APR
if unacceptable sphincter function would result from margin-negative tumor resection, including patients with poor baseline sphincter function
there is a loss of integrity of the intersphincteric plane
salvage procedure for treatment of anal squamous cell carcinoma
intersphincteric APR, involving resection between inner and outer sphincter, preserving exterior sphincter yet removing the rectal wall (mucosa, submucosa, and muscularis propria); indications includeprimarily used to treat patients with inflammatory bowel disease, especially Crohn disease (Dis Colon Rectum 2015 Nov;58(11):1021) if unamenable to restoration of gastrointestinal continuity
patients with ultralow rectal cancer wherethe sphincter complex is not involved
obtaining appropriate distal resection margin requires distal transection
extralevator APR (ELAPR or ELAPE) is an extrasphincteric resection that is widened laterally to the level of the levator ani complex insertion into the pelvic sidewallindicated specifically forlow rectal tumors that threaten the external sphincter or the levator complex where clear circumferential margin cannot be achieved through less radical APR
tumor that extends < 1 cm from dentate line (T3-T4 cancer)
tumor that threatens the circumferential margin
ischioanal APR is a more radical resection than ELAPR that is widened beyond the external sphincter to include ischioanal fat and/or skin; indications includelocally advanced cancer that infiltrates ischioanal fat, levator muscles, or perianal skin
perforated cancer with fistula or abscess in ischioanal compartment
Laparoscopic vs. Open Approach
primary surgical approaches are open and laparoscopic (LAP); alternatives are robotic and transanal (Ann Gastroenterol Surg 2020 Nov;4(6):628full-text)(3)consider minimal approaches to total mesorectal excision (TME) if they would typically be performed by experienced surgeons with technical expertise (ASCRS Strong recommendation, High-quality evidence)
due to perioperative and long-term outcomes, transanal TME remains controversial (ASCRS Strong recommendation, Moderate-quality evidence)
 LAP approach for transabdominal resection(2) not indicated for (NCCN Category 2A) locally advanced disease with threatened or high-risk circumferential margin based on staging analysis (open surgery preferred in these cases)
 acute bowel obstruction or perforation from cancer
 may be associated with similar short- and long-term outcomes as open surgery but may be associated with higher rate of circumferential margin positivity and incomplete TME (NCCN Category 2A)
 consider minimally invasive procedure based on the following factors (NCCN Category 2A) surgeon’s experience performing minimally invasive proctectomy with TME
 thorough abdominal exploration is a requirement of the procedure, and if there are individual patient circumstances making this difficult with minimal approach, open approach may be preferred
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommendations for LAP resection of curable rectal cancer preoperative assessment and preparation localize tumor (SAGES Strong recommendation, Low-quality evidence) mark small lesions endoscopically with permanent tattoos to maximize surgeon’s ability to identify lesion
 if lesion localization uncertain, use colonoscopy intraoperatively
 evaluate chest, abdomen, and pelvis with computed tomography scan for patients with colon or rectal cancer (SAGES Strong recommendation, Low-quality evidence)
 use preoperative mechanical bowel preparation to facilitate manipulation of bowel and to facilitate intraoperative colonoscopy when needed (SAGES Weak recommendation, Low-quality evidence)
 rectum-specific surgical considerations perform preoperative locoregional staging with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) (SAGES Strong recommendation, Low-quality evidence)
 standard oncologic principles for resection of cancer include (SAGES Strong recommendation, Moderate-quality evidence)TME for mid- and lower-rectum tumors
 adequate distal margin (resect malignant lesions of upper rectum with ≥ 5-cm distal margin)
 ligation at the origin of arterial supply for involved rectal segment
 other surgical considerations for locally advanced adherent colon and rectal tumors (SAGES Weak recommendation, Low-quality evidence) en bloc resection recommended
 use open approach if en bloc resection cannot be performed laparoscopically
 use of wound protector at abstraction site and irrigation of port sites and extraction site incisions may reduce risk of abdominal wall cancer recurrence (SAGES Strong recommendation, Low-quality evidence)
 Reference – SAGES guideline on LAP resection of curable colon and rectal cancer (SAGES 2012 Feb)
evidenceEVIDENCE SYNOPSIS: Evidence comparing LAP and open surgical approaches for management of rectal cancer using abdominoperineal resection (APR).comparison of outcomes between LAP and open approaches is generally limited bysmall number of randomized trials and trials may be small or of low quality
inclusion criteria regarding surgical technique may be highly variant and can overlapmany studies include patients treated with > 1 type of surgery
TME may be a part of low anterior resection or APR
types of APR may not be specified
Studies comparing LAP vs. open approaches for abdominal surgery in patients with rectal cancer which are focused on patients treated with APR do not include high-quality larger randomized trials. Nevertheless, the LAP approach appears to be associated with some improved nononcologic outcomes. While an earlier review based on smaller (< 500 total patients), older reports focused on APR suggested local and distant recurrence rates might be higher for LAP surgery, oncologic outcomes do not appear to differ between techniques when a larger (> 20,000 patients) more current evidence base is used for analysis. Both comparisons found no significant differences in overall survival.
Review of studies focused on intersphincteric APR includes a smaller evidence base (894 patients) with findings that appear to support improved nononcologic outcomes but which associate LAP surgery with fewer harvested lymph nodes and higher proximal resection margin distance.
comparing laparoscopic APR (LAPR) (of any type) with open APR (OAPR) (of any type)LAPR appears associated with improved non-oncologic operative outcomes and postoperative complications compared with OAPR, but oncologic and survival outcomes do not appear different in patients with rectal cancer (level 2 [mid-level] evidence) based on systematic review of studies with methodologic limitations
systematic review of 3 randomized trials and 18 observational studies evaluating LAPR (5,548 patients) vs. OAPR (14,795 patients) for intraoperative, pathological, and postoperative outcomes in analysis of 20,343 patients with rectal cancer
all trials were limited by lack of outcome assessor blinding and incomplete dropout rate data; and 1 trial had unclear randomization method
LAPR associated with differences in operative outcomes includingless blood loss (mean difference [MD] -136 mL, 95% CI -195 to -77 mL) in analysis of 12 studies with 988 patients, results limited by significant heterogeneity
less need for intraoperative blood transfusion in analysis of 2 studies with 154 patientsodds ratio (OR) 0.2 (95% CI 0.08-0.55)
NNT 4-10 with transfusion required in 30% of OAPR group
lower number of hospital days (MD -3.13 days, 95% CI -4.55 to -1.71 days) in analysis of 17 studies with 19,793 patients, results limited by significant heterogeneity
lower number of postoperative hospital days (MD -2.54 days, 95% CI -3.29 to -1.79 days) in analysis of 3 studies with 522 patients
shorter time to first flatus (MD -0.75 days, 95% CI -1.26 to -0.25 days) in analysis of 6 studies with 699 patients, results limited by significant heterogeneity
shorter time to first bowel movement (MD -0.9, 95% CI -1.62 to -0.18) in analysis of 3 studies with 174 patients
shorter time to first fluid diet (MD -2.53 days, 95% CI -4.25 to -0.81 days) in analysis of 4 studies with 273 patients, results limited by significant heterogeneity
shorter time to first solids diet (MD -3.26 days, 95% CI -4.23 to -2.29 days) in analysis of 3 studies with 240 patients
shorter time to first normal diet (MD 1.18 days, 95% CI -1.46 to -0.9 days) in analysis of 4 studies with 427 patients
LAPR associated with reduced rates of postoperative complications includingileus (OR 0.9, 95% CI 0.83-0.98) in analysis of 7 studies with 18,217 patients
abdominal wound infection (OR 0.27, 95% CI 0.1-0.75) in analysis of 3 studies with 550 patients
urinary tract infection (OR 0.83, 95% CI 0.72-0.96) in analysis of 7 studies with 19,365 patients
deep vein thrombosis (OR 0.16, 95% CI 0.04-0.66) in analysis of 3 studies with 1,675 patients
total postoperative complications (OR 0.69, 95% CI 0.52-0.91) in analysis of 7 studies with 2,055 patients
no significant differences in overall or disease-free 3- or 5-year survival, operating time, number of lymph nodes harvested, specimen length, positive circumferential margins, local recurrence, or wound recurrence
Reference – J Laparoendosc Adv Surg Tech A 2018 May;28(5):526
LAPR and OAPR may have similar overall survival, but open approach might have higher local and distant recurrence rates (level 2 [mid-level] evidence) based on systematic review with trial-specific quality measures not reported
 systematic review of 8 studies (3 randomized trials and 5 observational studies) comparing LAPR vs. OAPR in 454 adults with rectal cancer
 mean age was 63 years, and mean follow-up period was 44.2 months for LAP group and 49 months for open group
 no significant differences in overall survival in analysis of 3 studies in patients with stage I-III disease
 individual early postoperative complications (reoperations, and in intraoperative and perineal complications)
 length of hospital stay
 OAPR associated with increased local recurrence rate in analysis of 6 studies with 370 patients odds ratio 2.77 (95% CI 1.14-6.58)
 NNH 5-195 with local recurrence in 3.9% of LAP group
 distant recurrence rate in analysis of 5 studies with 344 patients; significant but confidence interval includes differences that may not be clinically important odds ratio 1.99 (95% CI 1.06-3.72)
 NNH 4-153 with distant recurrence in 12% of LAP group
 in sensitivity analysis including only randomized trials, no significant differences in local and distant recurrence rate
 Reference – Colorectal Dis 2013 Mar;15(3):269
comparing laparoscopic intersphincteric APR (LIAPR) with open intersphincteric APR (OIAPR)LIAPR in patients with rectal cancer appears associated with improved non-oncologic operative outcomes and postoperative complications but fewer harvested lymph nodes and higher distance of proximal resection margin compared with OIAPR (level 2 [mid-level] evidence) based on systematic review of observational studies
systematic review of 8 case-control studies (6 articles and 2 abstracts) evaluating LIAPR (515 patients) vs. OIAPR (379 patients) for intraoperative, pathological, and postoperative outcomes in analysis of 894 patients with rectal cancer
LIAPR associated with differences in operative outcomes includingless blood loss (mean difference [MD] -123 mL, 95% CI -173 to -74 mL) in analysis of 7 studies with 719 patients, results limited by significant heterogeneity
lower number of postoperative hospital days (MD -1.34 days, 95% CI -2.14 to -0.53 days) in analysis of 3 studies with 259 patients, results limited by significant heterogeneity
shorter time to first flatus (MD -0.56 days, 95% CI -0.87 to -0.25 days) in analysis of 3 studies with 336 patients
LIAPR associated with worse postoperative oncologic measures includinglower number of lymph nodes harvested (MD -1.58, 95% CI -2.89 to -0.26) in analysis of 6 studies with 571 patients
higher distance of proximal resection margin (MD 1.49 cm, 95% CI 0.43-2.54 cm) in analysis of 2 studies with 347 patients
LIAPR associated with reduced rates of postoperative complications includingpneumonia in analysis of 3 studies with 495 patientsodds ratio 0.33 (95% CI 0.14-0.76)
NNT 13-51 with pneumonia in 9% of OIAPR group
morbidity in analysis of 5 studies with 738 patientsodds ratio 0.64 (95% CI 0.45-0.91)
NNT 8-52 with morbidity in 30% of OIAPR group
no significant differences in operative mortality or time, 5-year overall or disease-free survival, R0 resection, distance of distal resection margin, circumferential resection margin (CRM) or CRM positivity, or postoperative ileus, wound infection, abscess, anastomotic leakage or stricture, or urinary complication were reported
Reference – J Laparoendosc Adv Surg Tech A 2018 Feb;28(2):189
EVIDENCE SYNOPSIS: Evidence comparing laparoscopic TME (LTME) with open TME (OTME) (studies include patients treated with lower anterior resection and patients treated with APR).Many studies have compared LAP vs. open approaches for TME. Key trials (see Table below) comparing LAP vs. open approaches for TME to treat rectal cancer have inconsistent findings. The COLORII trial reported no significant differences in recurrence or 3-year survival, while later ACOSOG and ALaCaRT trials failed to find LAP surgery noninferior to open surgery for TME as fewer LAP patients met requirements for composite endpoints aimed at determining whether oncologic goals were met. Later studies following these patients report no significant differences in recurrence or disease-free survival outcomes but statistical analyses were not based on testing for noninferiority.
When conclusions from meta-analyses are combined, the results are equivocal and may reflect confounders, such as, evolving surgical techniques. The most recent systematic review reports LAP may increase rates of circumferential margin involvement (CMI) but also reported no significant differences in TME completion. These outcomes directly conflict with an earlier review that reports a higher risk for incomplete TME for LAP, but that CMI and lymph node retrieval may be similar. Additionally, an earlier Cochrane review reports LAP may have similar 5-year survival to open surgery, consistent with the long-term follow-up reports from ACOSOG and ALaCaRT trials, which were not included in the Cochrane analysis. Note that these studies primarily looked at patients who had low anterior resection rather than the APR procedure, which may limit the generalizability of these findings to the APR procedure.

Table

Table 4: Key Trials Studying LAP vs. OPN Approach for TME Surgery to Treat Rectal Cancer

TrialMethods% APR*Oncologic OutcomesNon-oncologic Outcomes
COLORII (see summary of 2015 report, 2013 substudy, and 2019 substudy)RCT noninferiority trial with 1,103 patients with nonmetastatic rectal adenocarcinoma ≤ 15 cm from anal verge, followed up to 1 yearSubstudy with 385 patients responding to questionnaire at 1-year follow-upSecondary study with 1,044 patients at median of 61 months29% (LAP) and 27% (OPN) of tumors were located within 5 cm of anal verge**Rates of 3-year locoregional recurrence and overall survival may be similarBoth approaches associated with similar health-related quality of lifeSimilar risk of bowel obstruction, incisional hernia, or parastomal hernia
ACOSOG Z5061 (see 2015 summary and 2019 substudy) with similar results seen in ALaCaRT (see ALaCaRT and 2019 substudy)RCT noninferiority trial with 486 adults (mean age 57 years) with clinical stage II/III rectal cancerSubstudy with 486 adultsALaCaRT RCT noninferiority trial with 402 patients with clinical stage II/III rectal cancerSubstudy with 475 adults23% (LAP), 24% (OPN)ALaCaRT 8% (LAP), 7% (OPN)LAP-assisted resection may not be as effective for successful resection as OPN resection in patients with stage II/III rectal cancer2-year disease-free survival and recurrence may be similarLAP associated with longer operating time and less blood lossNo significant differences seen with length of stay, readmission, or severe complications

Citation: Abbreviations: APR, abdominoperineal resection; LAP, laparoscopic; OPN, open; RCT, randomized controlled trial; TME, total mesorectal excision.* Percentage of patients treated with APR; other patients treated with low or very-low anterior resection; all patients treated with TME.** APR was likely used in these cases but resection technique was not specifically reported.

comparing LTME with OTME (studies include patients treated with lower anterior resection and patients treated with APR)

  •  some studies have shown that LTME has similar rate of locoregional recurrence, and disease-free and overall survival compared to open surgery, although, other studies have shown the laproscopic approach to be associated with higher rates of CRM positivity and incomplete TME(1,2)
  • LTME may increase rates of CMI and operating time compared with OTME in patients with rectal cancer (level 2 [mid-level] evidence)
    •  based on systematic review with inadequate reporting of individual trial quality
    • systematic review of 5 randomized trials evaluating LTME (638 patients) vs. OTME (578 patients) for intraoperative, pathological, and postoperative outcomes in analysis of 1,216 patients with rectal cancer
    • mesorectal excision performed as part of anterior resection (83% of patients), APR (15% of patients), Hartmann procedure, total proctocolectomy, and intersphincteric APR
    • conversion to OTME required for 8.2% of LTME procedures
    • LTME associated with differences in operative outcomes including
      • higher CMI in analysis of 5 trials with 1,131 patients (odds ratio 1.55, 95% CI 0.99-2.41, but confidence intervals include possibility of benefit or harm; p = 0.05)
      • longer operating time (mean difference 42 minutes, 95% CI 24-60 minutes) in analysis of 4 studies with 252 patients
    • there were no significant differences in noncomplete mesorectal excision, number of lymph nodes harvested, distance to distal margin, blood loss, postoperative hospital stay, or postoperative complication rates
    • Reference – PLoS One 2020;15(7):e0235887full-text
  • in patients with rectal cancer, LTME may have similar 5-year survival and may reduce wound infection and bleeding compared to OTME (level 2 [mid-level] evidence)
    •  based on Cochrane review of trials without blinding
    •  systematic review of 14 randomized trials comparing LTME vs. OTME in 3,528 patients with rectal cancer
    • for long-term outcomes
      •  no significant differences in overall or disease-free survival at 5 years (odds ratio [OR] 1.02, 95% CI 0.76-1.38) in analysis of 4 trials with 948 patients, but confidence intervals include possibility of benefit or harm
      • LTME associated with decreased intestinal obstruction in analysis of 3 trials with 508 patients
        •  OR 0.3 (95% CI 0.12-0.75)
        •  NNT 15-54 with intestinal obstruction in 8% of OTME group
    • for short-term outcomes
      • LTME associated with
        • decreased wound infection in analysis of 10 trials with 3,337 patients
          •  OR 0.68 (95% CI 0.5-0.93)
          •  NNT 35-253 with wound infection in 6% of OTME group
        • decreased bleeding complications in analysis of 5 trials with 1,181 patients
          •  OR 0.3 (95% CI 0.1-0.93)
          •  NNT 56-728 with bleeding complications in 2% of OTME group
        •  shorter hospital stay (mean difference -2.16 days, 95% CI -3.22 to -1.1 days) in analysis of 11 trials with 3,084 patients, results limited by significant heterogeneity
      • no significant differences in
        •  urinary complications in analysis of 8 trials with 1,756 patients
        •  anastomotic leakage in analysis of 10 trials with 2,505 patients
        •  reoperation in analysis of 7 trials with 2,316 patients
    •  Reference – Cochrane Database Syst Rev 2014 Apr 15;(4):CD005200
  • LAP surgery and open surgery may have similar rates of 3-year locoregional recurrence and overall survival in patients with nonmetastatic rectal cancer (level 2 [mid-level] evidence)
    •  based on randomized noninferiority trial (COLOR II) without blinding of outcome assessors
    •  1,103 patients with nonmetastatic rectal adenocarcinoma ≤ 15 cm from anal verge were randomized to LAP vs. open partial or TME and followed for 3 years
    •  33% received preoperative chemotherapy and 59% preoperative radiotherapy
    •  noninferiority margin for LAP surgery was upper limit of 90% CI < 5% for difference between groups in locoregional recurrence at 3 years
    •  59 patients excluded from analyses for metastasis, lack of carcinoma, or other reason
    • comparing LAP vs. open surgery
      •  locoregional recurrence rate 5% vs. 5% (90% CI 2.6% lower to 2.6% higher, noninferiority met)
      •  overall survival 86.7% vs. 83.6% (not significant)
      •  disease-free survival 74.8% vs. 70.8% (not significant)
      •  distant metastasis in 19.1% vs. 22.1% (no p value reported)
    •  Reference – COLOR II trial (N Engl J Med 2015 Apr 2;372(14):1324full-text), commentary can be found in Colorectal Dis 2016 Mar;18(3):233
    • CLINICIANS’ PRACTICE POINT: APR was probably used in 29% of LAP and 27% of open approach patients; tumors for these patients were within 5 cm of the anal verge, but the resection type was not specifically reported.
    • LAP and open surgery associated with similar health-related quality of life (level 2 [mid-level] evidence)
      •  based on substudy of COLOR II trial with low compliance
      •  385 patients completed health-related quality of life questionnaires
      •  79% reported 12-month outcomes
      •  no significant differences comparing LAP vs. open surgery in health-related quality of life at 4 weeks, 6 months, or 1 year
      •  both groups reported deterioration to moderate-to-severe levels postoperatively followed by gradual return to preoperative levels over time
      •  Reference – Br J Surg 2013 Jun;100(7):941full-text, correction can be found in Br J Surg 2016 Nov;103(12):1746
    • LAP and open surgery associated with similar risk of bowel obstruction, incisional hernia, or parastomal hernia (level 2 [mid-level] evidence)
      •  based on prespecified secondary analysis of COLOR II trial
      •  1,044 patients who had LAP or open surgery were followed for median of 61 months
      • comparing LAP vs. open surgery
        •  ≥ 1 episode of bowel obstruction in 12.5% vs. 11.9% (not significant)
        •  incisional hernia in 18.7% vs. 17% (not significant)
        •  parastomal hernia in 17.4% vs. 9.3% (not significant, p = 0.066)
      •  no significant differences in rates of readmission or reoperation due to bowel obstruction, incisional hernia, or parastomal hernia
      •  Reference – Ann Surg 2019 Jan;269(1):53
  • LAP resection may have higher risk of noncomplete mesorectal excision than open resection, but may have similar risk of positive CRM and numbers of retrieved lymph nodes in patients with rectal cancer (level 2 [mid-level] evidence)
    •  based on systematic review of trials without clinical outcomes
    •  systematic review of 14 randomized trials comparing LAP vs. open partial or TME in 4,034 adults (median age 63 years, 57% men) with rectal cancer
    •  conversion from LAP resection to open resection required in 13.1%
    •  9 studies defined positive CRM as ≤ 1 mm from closest tumor to cut edge of tissue; 1 study failed to
    • define criteria for positive CRM
    • LAP resection associated with increased risk of noncomplete (defined as incomplete or nearly complete) mesorectal excision in analysis of 5 trials with 2,352 patients
      •  risk ratio 1.31 (95% CI 1.05-1.64)
      •  NNH 15-200 with noncomplete excision in 10% of open resection group
    • no significant differences in
      •  risk of positive CRM in analysis of 9 trials with 2,989 patients
      •  risk of positive distal resection margin in analysis of 2 trials with 935 patients
      •  distance to radial margin in analysis of 4 trials with 2,102 patients
      •  distance to distal margin in analysis of 6 trials with 2,547 patients
      •  number of lymph nodes retrieved in analysis of 12 trials with 3,170 patients
    •  Reference – JAMA Surg 2017 Apr 19;152(4):e165665, editorial can be found in JAMA Surg 2017 Apr 19;152(4):e165659
    • LAP-assisted resection may not be as effective for successful resection as open resection in patients with stage II/III rectal cancer (level 2 [mid-level] evidence)
      •  based on randomized noninferiority trial with allocation concealment inadequately described
      •  486 adults (mean age 57 years) with clinical stage II/III rectal cancer (body mass index [BMI] ≤ 34, Eastern Cooperative Oncology Group [ECOG] score < 3, and histologically proven adenocarcinoma of rectum ≤ 12 cm above anal verge) were randomized to LAP vs. open resection
      •  all patients completed neoadjuvant fluorouracil-based chemoradiation or radiation therapy alone prior to surgery
      • 23% of LAP and 24% of open approach patients were treated with APR
      •  successful resection defined as negative distal and circumferential radial margins and complete or nearly complete TME
      •  noninferiority of LAP resection defined as successful resection rate < 6% lower than with open resection at limit of 1-sided 95% CI for difference
      •  in laparoscopy group, 17.1% were hand assisted and 14.2% were robotic assisted, 11.3% of laparoscopies converted to open resection
      •  89.5% included in per-protocol analysis and 95% included in intention-to-treat analysis (all patients who had surgery)
      • comparing LAP vs. open resection
        •  successful resection rate 81.7% vs. 86.9% (limit of 95% CI for difference 10.8% lower, noninferiority not met) in per-protocol analysis
        • estimated mean blood loss 256.1 mL vs. 318.4 mL (p = 0.004)
        •  operative time 266.2 minutes vs. 220.6 minutes (p < 0.001)
        •  mean length of hospital stay 7.3 days vs. 7 days (not significant)
        •  readmission within 30 days in 3.3% vs. 4.1% (not significant)
        •  severe complications in 22.5% vs. 22.1% (not significant)
      •  consistent results for successful resection rates in intention-to-treat analysis
      •  Reference – ACOSOG Z6051 trial (JAMA 2015 Oct 6;314(13):1346full-text)
    •  consistent results not meeting noninferiority criteria for successful resection outcome in per-protocol analysis of noninferiority trial in 402 patients with clinical stage II/III rectal cancer comparing LAP vs. open resection in ALaCaRT trial (JAMA 2015 Oct 6;314(13):1356), editorial can be found in JAMA 2015 Oct 6;314(13):1343, commentary can be found in JAMA Oncol 2017 Jan 1;3(1):113, Br J Surg 2017 May;104(6):643

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