Abstract
BackgroundAn inappropriate anastomosis method during laparoscopic anterior rectal resection can increase the risk of anastomotic complications and affect surgical, economic, and oncological outcomes. The aim of this study is to compare the incidence of anastomotic complications and the surgical, economic, and oncological outcomes following single versus double purse-string anastomosis during laparoscopic total mesorectal excision (TME) for low rectal cancer.Methods/designThis randomized controlled trial (the SINGLE–DOUBLE study) will randomly assign middle and low rectal adenocarcinoma patients to receive either single or double purse-string anastomosis during laparoscopic low anterior rectal resection. Patients will be eligible for inclusion only if they (1) have adenocarcinoma confirmed by preoperative colonoscopy and biopsy, (2) have a tumor situated less than 12 cm from the anal verge, (3) do not have the anal sphincter involved, and (4) do not have distant metastases. The primary endpoint measure will be the incidence of anastomotic complications (leakage, narrowing, and bleeding). The secondary endpoints will be surgical, economic, and oncological outcomes. A total of 500 patients will be enrolled in the study. Sample size calculation was based on previous reports and our retrospective analysis.DiscussionThis randomized single-center controlled trial is expected to demonstrate which anastomosis method (single or double purse-string anastomosis) is better for reducing complications and improving prognosis in rectal cancer patients undergoing laparoscopic TME for low or middle rectal cancer.Trial registrationRegistration number: ChiCTR1800016116. Protocol Registration Receipt: May 13, 2018.
Highlights
An inappropriate anastomosis method during laparoscopic anterior rectal resection can increase the risk of anastomotic complications and affect surgical, economic, and oncological outcomes
In 1979, Ravitch and Steichen [14] first proposed the end-to-end anastomosis for low rectal cancer. This procedure was improved by the use of a straight-line stapler (TA-55) to close the distal rectal segment, an end-to-end colorectal anastomosis performed using double staplers, and a tubular stapler inserted through a linear stapler via the anus
According to Griffen et al [15], this kind of anastomosis has several advantages: (1) it avoids the technical difficulties involved in distal rectal suturing, (2) it makes anus-preserving surgery in lower rectal cancer technically feasible, (3) it reduces the possibility of contamination because the distal rectal segment is not opened, and (4) it makes it possible to connect intestinal segments of different diameters and reduces the complications of anastomosis
Summary
An inappropriate anastomosis method during laparoscopic anterior rectal resection can increase the risk of anastomotic complications and affect surgical, economic, and oncological outcomes. According to Griffen et al [15], this kind of anastomosis has several advantages: (1) it avoids the technical difficulties involved in distal rectal suturing, (2) it makes anus-preserving surgery in lower rectal cancer technically feasible, (3) it reduces the possibility of contamination because the distal rectal segment is not opened, and (4) it makes it possible to connect intestinal segments of different diameters (the wider rectal ampulla and the narrower sigmoid colon) and reduces the complications of anastomosis This anastomosis method is widely applied, and laparoscopic linear stapling is used to close rectal stump. The procedure is difficult to perform within the confines of the pelvic space
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