Single vs. double stapling and purse-string techniques after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center randomized study at Alexandria University will compare single-stapled versus double-stapled colorectal anastomosis after low anterior resection with total mesorectal excision for rectal adenocarcinoma. Within the single-stapling group, participants are further randomized to intracorporeal versus transanal placement of the purse-string suture. Primary aims include differences in anastomotic healing and leakage rates, with secondary assessments of oncologic resection quality and patient-reported bowel function and quality of life. Allocation is intraoperative and uses independent randomization to ensure unbiased group assignment. A total of 124 adults aged 18-80 will be enrolled, with 62 in the double-stapling arm and 31 in each single-stapling subgroup.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alexandria University
  Alexandria, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed Mohi eldein, PhD
• Email: Ahmed.eldaoushy@alexmed.edu.eg
• Phone: +201281362223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.