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Recruiting NCT07929415

Single Versus Double Stapling and Two Purse-String Techniques in Rectal Cancer Surgery

Conditions: Rectal Cancer

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 124
Sponsor: Alexandria University

Location: Alexandria University Alexandria

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07929415). StuddyBuddy aggregates publicly available trial information.