Expert Opinion on Laparoscopic Surgery for Colorectal Cancer Parallels Evidence from a Cumulative Meta-Analysis of Randomized Controlled Trials

IMPORTANCE Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6%noninferiority margin was chosen according to clinical relevance estimation. RESULTS Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7%of laparoscopic resection cases (95%CI, 76.8%–86.6%) and 86.9%of open resection cases (95%CI, 82.5%–91.4%) and did not support noninferiority (difference, −5.3%; 1-sided 95%CI, −10.8%to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3%of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95%CI, 27.7–63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95%CI, −0.6 to 1.1), readmission within 30 days (3.3%vs 4.1%; difference, −0.7%; 95%CI, −4.2%to 2.7%), and severe complications (22.5%vs 22.1%; difference, 0.4%; 95%CI, −4.2%to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5%of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3%open resection; P = .11). Distal margin result was negative in more than 98%of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00726622

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“…In all of the comparisons, the potential for diminished outcome with laparoscopic resection compared with open resection was observed. 8–10,12 …”

Section: Discussionmentioning

confidence: 99%

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

Fleshman

Branda

Sargent

et al. 2015

JAMA

997

744

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“…3 a recent review on expert opinion regarding laparoscopic surgery for colorectal cancer found a changing dynamic of the opinion of laparoscopic surgery. 4 the authors found that, initially (in 1991 and 1992), the majority of expert opinion was that laparoscopic surgery was inferior to open surgery. from 1993 to 2003, most experts believed that further trials were needed before conclusions could be drawn.…”

mentioning

confidence: 99%

The Use of “Spin” in Laparoscopic Lower GI Surgical Trials with Nonsignificant Results

Patel

Chadi

Choi

et al. 2013

Diseases of the Colon &Amp; Rectum

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“…Martel G et al, [8], in extensive cumulative meta-analysis which they did for RCTs, randomized 5782 patients into laparoscopic (n=3,031) and open (n=2751) colorectal surgery groups. They reported that laparoscopic surgery done for colon cancer was noninferior to open surgery in terms of overall survival and that it has been so since 2004.…”

Section: Resultsmentioning

confidence: 99%

Laparoscopic Colorectal Surgery: An Update (with Special Reference to Indian Scenario)

Moirangthem¹

2014

JCDR

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Laparoscopic cholecystectomy, being already declared as gold standard technique, laparoscopic surgery has advanced far and wide, touching almost every corner of the abdomen. This advancement has gradually expanded to colorectal surgery which is done for malignant diseases as well. However, laparoscopic colorectal surgery has not been accepted as quickly as was laparoscopic cholecystectomy. This is because of its steep learning curve, concerns with oncological outcomes, lack of randomized control trials (RCTs) and initial reports on high port site recurrences which occurred after curative resections. But all these initial concerns have been overcome by doing a series of RCTs globally, in the past decade, that revealed that laparoscopic colorectal surgery for malignant disease offered short term benefits without compromising on oncological principles of radicality of resection, tumour resection margins and completeness of lymph node harvesting as compared to those of open surgery. Favourable post-operative results with respect to less blood loss, less pain, lesser surgical site infections, lesser requirement of analgesics, early return of bowel function and shorter hospital stay in patients who underwent laparoscopic colorectal resections were obtained in studies done on individual series, including those done in India and more recently, in large trials. An update on recent studies done on laparoscopic colorectal surgery by reviewing many RCTs and individual series, including our experiences, was made, to support the advantages of this procedure which were obtained when it was carried out by skilled hands.

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Expert Opinion on Laparoscopic Surgery for Colorectal Cancer Parallels Evidence from a Cumulative Meta-Analysis of Randomized Controlled Trials

Cited by 48 publications

References 50 publications

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

The Use of “Spin” in Laparoscopic Lower GI Surgical Trials with Nonsignificant Results

Laparoscopic Colorectal Surgery: An Update (with Special Reference to Indian Scenario)

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