Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer

Abstract

IMPORTANCE The efficacy of laparoscopic vs open surgery for patients with low rectal cancer has not been established. OBJECTIVE To compare the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer. DESIGN, SETTING, AND PARTICIPANTS This multicenter, noninferiority randomized clinical trial was conducted in 22 tertiary hospitals across China. Patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery. Between November 2013 and June 2018, 1070 patients were randomized to laparoscopic (n = 712) or open (n = 358) surgery. The planned follow-up was 5 years. Data analysis was performed from April 2021 to March 2022. INTERVENTIONS Eligible patients were randomized to receive either laparoscopic or open surgery. MAIN OUTCOMES AND MEASURES The short-term outcomes included pathologic outcomes, surgical outcomes, postoperative recovery, and 30-day postoperative complications and mortality. RESULTS A total of 1039 patients (685 in laparoscopic and 354 in open surgery) were included in the modified intention-to-treat analysis (median [range] age, 57 [20-75] years; 620 men [59.7%]; clinical TNM stage II/III disease in 659 patients).The rate of complete mesorectal excision was 85.3% (521 of 685) in the laparoscopic group vs 85.8% (266 of 354) in the open group (difference, −0.5%; 95% CI, −5.1% to 4.5%; P = .78). The rate of negative circumferential and distal resection margins was 98.2% (673 of 685) vs 99.7% (353 of 354) (difference, −1.5%; 95% CI, −2.8% to 0.0%; P = .09) and 99.4% (681 of 685) vs 100% (354 of 354) (difference, −0.6%; 95% CI, −1.5% to 0.5%; P = .36), respectively. The median number of retrieved lymph nodes was 13.0 vs 12.0 (difference, 1.0; 95% CI, 0.1-1.9; P = .39). The laparoscopic group had a higher rate of sphincter preservation (491 of 685 [71.7%] vs 230 of 354 [65.0%]; difference, 6.7%; 95% CI, 0.8%-12.8%; P = .03) and shorter duration of hospitalization (8.0 vs 9.0 days; difference, −1.0; 95% CI, −1.7 to −0.3; P = .008). There was no significant difference in postoperative complications rate between the 2 groups (89 of 685 [13.0%] vs 61 of 354 [17.2%]; difference, −4.2%; 95% CI, −9.1% to −0.3%; P = .07). No patient died within 30 days. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial of patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons was shown to provide pathologic outcomes comparable to open surgery, with a higher sphincter preservation rate and favorable postoperative recovery.

Laparoscopic vs Open Surgery for Low Rectal Cancer—Reply

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COMMENT & RESPONSEIn Reply We appreciate the comments by Yuan et al regarding our recent Original Investigation. 1 During the surgical operation, we strictly followed the study design of at least 10 cm for proximal resection margin (PRM). The fact that one-fourth of patients in the laparoscopic group had a PRM of 9 cm or less most likely reflects the contraction of resected specimen from the time of resection to the time of measurement (typically at the end of surgery).

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Laparoscopic vs Open Surgery for Low Rectal Cancer

“…First, the authors reported a significantly shorter median length of proximal resection margin (PRM) in the laparoscopic group than the open group (124 vs 130 mm; P = .02). Additionally, the length of PRM of more than one-quarter of surgical specimens was 9 cm or less in the laparoscopic group, which is not consistent with the study design.…”

“…Finally, as the authors mentioned, diverting ostomy was performed in patients with high-risk anastomosis. It is reported that fecal diversion does most benefit to patients with a low rectal anastomosis, male sex, or neoadjuvant radiotherapy .…”

Methods, Complications, and Outcomes in a Randomized Clinical Trial of Electroacupuncture After Colorectal Cancer Surgery

“…However, the time to first defecation of more than half of patients in the EA group and more than three-quarters of patients in the SA group was longer than 3 days, which was inferior to the results of a recently published study from China. 2 The detailed Enhanced Recovery After Surgery (ERAS) protocol and the actual patient adherence in this trial should have been reported by the authors to help evaluate the efficacy of EA objectively in the setting of ERAS. Besides, the occurrence rate of POI in this trial was significantly higher than in several randomized clinical trials.…”

“…Besides, the occurrence rate of POI in this trial was significantly higher than in several randomized clinical trials. [2][3][4] It is critical for future studies to check and determine the definition and diagnostic criteria of POI.…”