Single-stapled colorectal anastomosis for left-sided colon surgery.
Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 5 sites (Gothenburg and 4 other locations) |
| Trial ID | NCT07417358 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Small single-center series have reported feasibility of single-stapled anastomosis with variable leak rates, but large multicenter comparative evidence is limited.
Eligibility criteria
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 this trial is running
Gothenburg and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.