Clinical trial Recruiting at 5 sites Observational Ages 18 and up

Single-stapled colorectal anastomosis for left-sided colon surgery.

Official title: Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study

Run by Umeå University · NCT07417358 · Data updated 2026-11-12

This will try a single-stapled method to reconnect the colon in adults having planned left-sided colorectal surgery to see if it lowers the risk of leaks compared with the usual double-stapled method.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorUmeå University
Academic / other
Locations5 sites (Gothenburg and 4 other locations)
StatusRecruiting
StartedJanuary 7, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2029
Registry record updatedFebruary 18, 2026
Trial IDNCT07417358 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) scheduled for elective left-sided colorectal resection with a planned colorectal anastomosis (sigmoid resection, left hemicolectomy, or partial mesorectal excision) for benign or malignant disease are eligible, with prospective participants able to provide informed consent.

Probably not a fit

Patients requiring total mesorectal excision (low rectal cancer), right-sided colectomies, procedures without an anastomosis (e.g., end colostomy/Hartmann's), or emergency/urgent resections are excluded and unlikely to benefit from this study's technique.

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

What this trial studies

This observational multicenter study enrolls adults undergoing elective left-sided colorectal resections (sigmoid resection, left hemicolectomy, or partial mesorectal excision) who receive a single-stapled colorectal anastomosis and compares outcomes to a retrospective double-stapled cohort. The primary outcome is anastomotic leakage within 90 days, and secondary aims include feasibility and safety across open, laparoscopic, and robot-assisted approaches. Data are collected prospectively at several Swedish university hospitals and supplemented by medical-record review of eligible cases operated during 2023–2025. The study is non-randomized and focuses on real-world surgical practice across multiple centers.

Why it matters

Potential benefit: If successful, the technique could reduce postoperative anastomotic leaks and their complications, potentially lowering reoperations, stoma rates, and hospital stays.

How similar studies have gone: Small single-center series have reported feasibility of single-stapled anastomosis with variable leak rates, but large multicenter comparative evidence is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years.
* Planned (elective) left-sided colorectal resection with creation of a colorectal anastomosis, including: Left hemicolectomy, and/or Sigmoid resection, and/or Partial mesorectal excision (PME).
* Benign or malignant indication.
* Prospective cohort: Ability to provide written informed consent.
* Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria.

Exclusion Criteria:

* Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME).
* Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations.
* Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis).
* Emergency/urgent colorectal resection (non-elective surgery).
* Prospective cohort: Inability to provide informed consent.

Where it's running

  • Östra Sahlgrenska University Hospital
    Gothenburg, Sweden
    Recruiting
  • Sunderby Hospital
    Luleå, Sweden
    Recruiting
  • Skåne University Hospital
    Malmö, Sweden
    Recruiting
  • Surgical Centre, Umeå University Hospital
    Umeå, Sweden
    Recruiting
  • Uppsala University Hospital
    Uppsala, Sweden
    Recruiting

Study contacts

  • Principal investigator: Oskar Grahn, MD, PhD — Umea University / Region Vasterbotten
  • Study coordinator: Oskar Grahn, MD, PhD
  • Email: oskar.grahn@umu.se
  • Phone: +46907850000

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.