Better outcomes with open surgery vs. laparoscopic for rectal cancer

Key clinical point: Two studies evaluating resection results failed to show laparoscopic surgeries for colorectal cancer as noninferior to open procedures.

Major finding: Among patients with stage III or IV rectal cancers, 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%), not supporting noninferiority for laparoscopic procedures (P = .41 for noninferiority). Similarly, among patients with T1-3 rectal tumors, 82% assigned laparoscopic surgery and 89% in the open surgery group saw adequate resections (P = .38 for noninferiority).

Data source: Randomized trials of slightly under 500 patients each at multiple study sites in North America, Australia, and New Zealand.

Disclosures: Australian-led study was publicly and institutionally funded with no investigator disclosures; U.S.-led study had support from a device manufacturer and several coauthors disclosed support from this and other manufacturers.

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Laparoscopic vs. open: Inform patients of risks, benefits of each

The studies by Fleshman et al. and Stevenson et al. have set a standard for surgeons performing these complex operations and the surgical expertise that must be ensured when conducting randomized clinical trials. In both studies, only surgeons accredited after video review of relevant operations were allowed to participate, and the primary outcome was defined as the adequacy of surgical dissection as assessed by completeness of the total mesorectal excision, uninvolved CRM, and uninvolved distal resection margin. The technical quality of surgery in both trials was high as demonstrated by few laparoscopic conversions, high sphincter preservation rates, and low rates of anastomotic leakage and other complications in these study groups that included high-risk overweight patients, the majority of whom were male. Likewise, the composite pathologic success rate based on meeting all three surgical dissection criteria was very high. However, in both studies, the adequacy of surgical dissection tended to be lower in the minimally invasive group, compared with the open resection group despite comparable low rates of distal margin involvement. Although several nonrandomized studies with inherent selection bias have described the overall advantages of a minimally invasive approach for patients with rectal cancer or complicated diverticulitis, these large, randomized, multicenter trials substantiate recent findings from similar randomized trials. A laparoscopic resection may not be oncologically justified in many patients requiring proctectomy for rectal cancer. The studies do not signal a moratorium on laparoscopic approaches, but surgeons must proceed in a judicious manner to ensure that patients are informed about the benefits and risks associated with minimally invasive and open operations.

Dr. Scott A. Strong and Dr. Nathaniel J. Soper are with Northwestern University Feinberg School of Medicine, Chicago. Dr. Strong and Dr. Soper declared no conflicts of interest. These remarks were excerpted from an accompanying editorial (JAMA. 2015 Oct 6. doi: 10.1001/jama.2015.11454).




Two randomized studies of rectal cancer surgeries using highly qualified surgeons were not able to show that laparoscopic procedures produce results equal to open ones.

The studies, published online in JAMA, each enrolled slightly under 500 patients at multiple sites, randomized them to open pelvic dissection or laparoscopic dissection, and selected surgeons with exceptional skills.

Both studies found rates of pathologist-determined adequate surgical dissection to be slightly lower for patients undergoing the laparoscopic procedures.

The North American study was carried out under the American College of Surgeons Oncology Group and led by Dr. James Fleshman of Baylor University Medical Center, Dallas. The study, which took place at 35 surgical centers, enrolled 486 patients with stage II or III rectal cancer within 12 cm of the anal verge who were randomized after neoadjuvant therapy to minimally invasive (n = 240) or open proctectomy (n=222) (JAMA. 2015;314[13]:1346-55).

Success was measured by pathologic oncologic markers related to quality of the rectal specimen: 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 estimations for this patient group.

Successful resection occurred in 82% of laparoscopic resection cases (95% confidence interval, 76.8%-86.6%) and 87% of open cases (95% CI, 82.5%-91.4%). The results did not support noninferiority for laparoscopic procedures (P = .41).

The finding came as a surprise, Dr. Fleshman and colleagues wrote in their analysis, not least because of the skill level of the surgeons participating in the study. A group of “highly motivated, credentialed, expert laparoscopic rectal surgeons was ideal to test this hypothesis,” they wrote. Moreover, only 11% of patients assigned laparoscopy had to be converted to open procedures, “so the learning curve cannot be invoked to explain our results because conversion rates were reasonable.”

More likely, they wrote, “the technique itself, along with the current methodology available, must be questioned if motivated experts cannot produce a quality specimen defined by this novel combined metric.”

Proctectomy is always challenging, Dr. Fleshman and colleagues wrote, “and it can be even more difficult to work in the deep pelvis with in-line rigid instruments from angles that require complicated maneuvers to reach the extremes of the pelvis. It is possible that modification of instruments or a different platform such as robotics will improve efficacy of minimally invasive techniques.”

The Australian study, carried out by the Australasian Gastro-Intestinal Trials Group network and led by Dr. Andrew R. L. Stevenson of the University of Queensland and Royal Brisbane and Women’s Hospital, Brisbane, Australia, enrolled 475 patients with T1-3 rectal tumors less than 15 cm from the anal verge and randomized them to laparoscopic (n = 238) or open (n = 235) pelvic dissection. Half of patients had received radiotherapy before the operations. Some 26 surgeons operated at 24 sites in Australia and New Zealand. (JAMA. 2015;314[13]:1356-63).

For this trial, successful resection was defined as complete total mesorectal excision, a clear circumferential margin of at least 1 mm, and a clear distal resection margin of 1 mm or more. The prescribed noninferiority margin for this patient group was 8%. As in the North American study, pathologists were blinded to the method of surgery.

Successful resection occurred in 194 patients (82%) in the laparoscopic group and 208 (89%) in the open surgery group, not reaching noninferiority for the laparoscopic approach (P = 0.38 for noninferiority). Conversion to open dissection occurred in 9% of the laparoscopy-assigned patients.

“Even though our trial was not designed to demonstrate whether one method of rectal dissection was superior to the other, the inability to establish noninferiority suggests that surgeons should be cautious when considering the suitability of a laparoscopic approach for a patient with rectal cancer,” Dr. Stevenson and colleagues wrote in their analysis.

“Subgroup analyses raise the possibility that laparoscopic surgery might be less successful than open surgery in patients who have received neoadjuvant therapy, have larger T3 tumors, or have higher BMIs. However, our study was underpowered to show significant differences in proportions of lower success rates for laparoscopic surgery vs. open surgery.”

The North American trial was funded by the National Cancer Institute, the American Society of Colon and Rectal Surgeons, the Society of American Gastrointestinal and Endoscopic Surgeons, and the Covidien Company. Dr. Fleshman reported no conflicts, while several coauthors disclosed financial relationships with surgical device manufacturers, including Covidien.

The Australasian trial was funded by the Colorectal Surgical Society of Australia and New Zealand and the National Health and Medical Research Council. No conflicts of interest were reported.

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