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Taking people in SwedenNo phase

Single-stapled technique for joining the bowel after colon or rectal surgery

Looks at a stapling method for joining the bowel, in adults having surgery.

Plain-language title generated from the registry record
Registry title: Single-Stapled Technique for Colorectal Anastomosis

Key facts

Where
Gothenburg, Luleå, Malmö, Umeå, and Uppsala, SwedenSee the 5 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having planned surgery on the left side of the bowel with a join (anastomosis) between the bowel ends, for benign or cancer disease.

Age
18 years or older
Sex
All sexes can join
Disease stage
Benign or malignant disease needing planned left hemicolectomy, sigmoid resection or partial mesorectal excision (PME) with a colorectal anastomosis

Main reasons for not taking part

  • Total mesorectal excision (TME)
  • Right-sided or other resections outside the study-defined operations
  • Surgery without a colorectal anastomosis (for example Hartmann's procedure)
  • Emergency or urgent surgery
  • Not able to give informed consent (prospective part)

Read by machine on 9 November 2026.

Where in Sweden

  • Östra Sahlgrenska University HospitalGothenburg, SwedenTaking people
  • Sunderby HospitalLuleå, SwedenTaking people
  • Skåne University HospitalMalmö, SwedenTaking people
  • Surgical Centre, Umeå University HospitalUmeå, SwedenTaking people
  • Uppsala University HospitalUppsala, SwedenTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Umeå University
Trial code
NCT07417358
Record updated
18 February 2026
Original description
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).Read full original descriptionShow less

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

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, outcomes after single-stapled anastomosis will be compared with a retrospective cohort of patients operated with the conventional double-stapled technique to explore potential differences in anastomotic leakage rates and postoperative complications.

Participants will receive standard surgical care as determined by the treating surgical team. Patients included in the prospective part of the study will undergo colorectal anastomosis using the single-stapled technique as part of routine clinical practice. Data on perioperative variables, postoperative complications (including anastomotic leakage graded according to international consensus definitions), and follow-up outcomes will be collected prospectively using an electronic case report form (eCRF). A retrospective cohort from the same participating centers will be identified through medical record review using identical inclusion criteria.

The results of this study are intended to provide robust multicenter data on the safety and clinical outcomes of the single-stapled technique and to serve as the basis for planning a future randomized controlled multicenter trial.

Inclusion: 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: Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis); Emergency/urgent colorectal resection (non-elective surgery); 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; Prospective cohort: Inability to provide informed consent.

ClinicalTrials.gov NCT07417358