This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.
A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler. A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a three-row circular stapler, defunctioning colostomy is performed.
Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a two-row circular stapler, defunctioning colostomy is performed.
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Moscow, Russia
RECRUITINGAnastomotic leakage rate
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
Time frame: 6 weeks
Operating time
The duration of surgical procedure in minutes
Time frame: 1 day
Circular stapler misfunction rate
The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer
Time frame: 1 day
Anastomotic bleeding rate
The rate of bleeding from the line of stapled anastomosis verified by proctoscopy
Time frame: 30 days
Re-intervention rate
The rate of repeat surgeries due to anastomotic leakage
Time frame: 6 weeks
Early postoperative complications rate
The rate of complications in first 30 days after surgery
Time frame: 30 days
The postoperative hospital stay
The number of days from the first day after operation to discharge
Time frame: 1 month
Complications of defunctioning stoma
The rate of complications related to defunctioning stoma
Time frame: 3 months
Overall quality of life
Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Cancer-related quality of life
Assessed with patient-reported questionnaire EORTC QLQ-C30 with supplementary module EORTC QLQ-CR29. A total score in each of 4 modules (functional scale, global health status, symptom scale, colorectal cancer module) will be calculated and transformed into a 0-100 scale. For Functional scale, Global health status scale and Colorectal cancer module a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. For Symptom scale a score of 100 is equivalent to maximum disability and a score of 0 is equivalent to no disability.
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Manifestation of Low Anterior Resection Syndrome (LARS)
Assessed with patient-reported questionnaire LARS, total score will be calculated (min 0, max 42) for each patient and also each patient will be assigned to either "no LARS" group (total score 0-20), or "minor LARS" group (total score 21-29) or "major LARS" group (total score 30-42)
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Adverse events rate
The rate of adverse events related to circular stapler usage
Time frame: 12 months
Serious adverse events rate
The rate of serious adverse events related to circular stapler usage
Time frame: 12 months
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