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Single-Stapled Technique for Colorectal Anastomosis

Recruitingn/aAges 18 Years - anyAllUmeå University
NCT07417358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational multicenter study is to evaluate the safety and feasibility of a single-stapled technique (SST) for colorectal anastomosis and to explore whether this technique is associated with a reduced rate of anastomotic leakage compared with the conventional double-stapled technique (DST). The study includes adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis, including sigmoid resection, left hemicolectomy, or partial mesorectal excision (PME), for benign or malignant disease. The main questions it aims to answer are: What is the rate of anastomotic leakage within 90 days after surgery in patients operated with the single-stapled technique? Is the single-stapled technique feasible and safe across different surgical approaches (open, laparoscopic, and robot-assisted surgery) in a multicenter setting? Furthermore, outcome

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📋 Eligibility rules (as published)
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.
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What it tests

  • Single-stapled colorectal anastomosis
  • Double-stapled colorectal anastomosis
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Where

5 sites
Östra Sahlgrenska University Hospital
Gothenburg, Sweden
Sunderby Hospital
Luleå, Sweden
Skåne University Hospital
Malmö, Sweden
Surgical Centre, Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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