Overview
This study compares ways of joining the bowel after surgery for rectal cancer. It aims to find out whether using a single-stapling technique leads to fewer bowel leaks than using a double-stapling technique. It also compares two ways of placing the closing stitch used in the single-stapling technique.
The study will include 124 adults having planned surgery to remove rectal cancer while preserving the anus. After removing the affected part of the rectum, the surgeon joins the remaining bowel. A leak can occur if this join does not heal properly.
Participants will be assigned by chance during surgery to one of two techniques:
Double stapling: the surgeon closes the remaining rectum with a straight stapler, then uses a circular stapler to join the bowel.
Single stapling: the surgeon closes the remaining rectum with a drawstring-like stitch, then uses a circular stapler to join the bowel.
Participants assigned to single stapling will have a second assignment by chance. The surgeon will place the closing stitch either from inside the abdomen or through the anus.
The main outcome is a bowel leak that requires treatment within 30 days after surgery. Researchers will also compare other complications, recovery, findings from the removed cancer tissue, and whether the cancer returns locally during the first year.
Participants will be followed for 12 months after surgery. They will complete questionnaires about bowel function, bowel control, and quality of life at 6 and 12 months.
Description
This prospective, single-center randomized controlled trial will be conducted at the Colorectal Unit, Surgery Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt. It will compare single-stapled and double-stapled anastomoses following low anterior resection with total mesorectal excision for rectal adenocarcinoma. Within the single-stapling group, a second randomized comparison will evaluate intracorporeal versus transanal placement of the rectal stump purse-string suture.
The study addresses whether avoiding the intersection between linear and circular staple lines influences anastomotic healing. It will also examine whether the route of purse-string placement affects surgical outcomes, pathological measures of oncological resection, and patient-reported bowel function and quality of life.
Randomization will take place intraoperatively after the surgeon confirms curative resectability and technical feasibility of the allocated approaches. Participants will first be randomized in a 1:1 ratio to single stapling or double stapling. Participants allocated to single stapling will then undergo a second 1:1 randomization to intracorporeal or transanal purse-string placement. The planned allocation is therefore 62 participants to double stapling, 31 to single stapling with an intracorporeal purse-string, and 31 to single stapling with a transanal purse-string.
An independent statistician will prepare the computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, sealed, opaque envelopes until intraoperative randomization. Operating surgeons cannot be blinded. Outcome assessors, including imaging assessors, pathologists, and research staff administering patient-reported outcome questionnaires, will be blinded to allocation. Participants will remain blinded where feasible.
Experienced colorectal surgeons will perform standardized total mesorectal excision. In the double-stapling group, the rectum will be divided and closed with a linear stapler before creation of the anastomosis with a circular stapler. In the single-stapling groups, the rectum will be divided without a linear stapler, and the open rectal stump will be closed with an intracorporeal or transanal purse-string before circular stapling. A defunctioning stoma may be created at the operating surgeon's discretion according to clinical risk factors, and its use will be recorded.
Anastomotic leaks will be defined and graded using the International Study Group of Rectal Cancer classification. The primary comparison will assess clinically significant leaks requiring active treatment without relaparotomy or requiring relaparotomy, corresponding to Grade B or Grade C, within 30 days after surgery. Other postoperative complications will be classified using the Clavien-Dindo system.
Follow-up will assess postoperative recovery, anastomotic complications, pathological resection findings, and local recurrence through one year. Bowel function, fecal continence, and quality of life will be assessed using the Low Anterior Resection Syndrome score, Wexner incontinence score, and European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire at 6 and 12 months after surgery.
The sample size is based on the primary comparison between the combined single-stapling group and the double-stapling group. The primary analysis will follow the intention-to-treat principle, with a supplementary per-protocol analysis. Prespecified adjusted analyses will account for relevant clinical and operative factors. The intracorporeal versus transanal purse-string comparison will be analyzed separately within participants randomized to single stapling.
Eligibility
Inclusion Criteria:
- Age 18-80 years.
- Histologically confirmed rectal adenocarcinoma, with the tumor located within 16 cm of the anal verge, measured by rigid proctoscopy or magnetic resonance imaging.
- Candidate for elective sphincter-preserving low anterior resection with total mesorectal excision.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Ability to provide written informed consent.
Exclusion Criteria:
- Locally advanced disease unsuitable for curative resection or metastatic disease (M1).
- Emergency surgery for obstruction or perforation.
- Previous pelvic radiotherapy for conditions other than the current rectal cancer.
- Planned abdominoperineal resection or Hartmann's procedure.
- Coagulopathy or contraindication to the use of surgical stapling devices.
- Inability to complete follow-up questionnaires.
