Single-Stapled Technique for Colorectal Anastomosis

NCT07417358 | Recruiting

• 1 other identifier: SST-MC-2025
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colorectal Cancer; Colorectal Anastomosis; Anastomotic Leakage; Diverticular Disease of Left Side of Colon

Keywords

Single-stapled anastomosis; Colorectal anastomosis; Anastomotic leakage; Colorectal surgery; Left-sided colon resection; Partial mesorectal excision

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage (ISREC), within 90 days

  Anastomotic leakage following colorectal anastomosis, defined according to the International Study Group of Rectal Cancer (ISREC). Anastomotic leakage is recorded as a binary outcome (yes/no). Severity grading (ISREC Grade A, B, or C) will be reported descriptively as part of the same outcome.

  Within 90 days after surgery

Secondary Outcomes (10)

• Feasibility of the single-stapled technique (SST)

  During surgery

• Completeness of stapled anastomotic rings

  During surgery

• Intraoperative air leak test result

  During surgery

• Duration of surgery

  During surgery

• Length of postoperative hospital stay

  Within 90 days of primary surgery

Study Arms (2)

Prospective single-stapled technique cohort

Adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis (including sigmoid resection, left hemicolectomy, or partial mesorectal excision) in whom the anastomosis is constructed using the single-stapled technique (SST) as part of routine clinical practice. Patients are included prospectively and followed for postoperative complications, including anastomotic leakage within 90 days, as well as longer-term outcomes.

Procedure: Single-stapled colorectal anastomosis

Retrospective double-stapled technique cohort

A retrospective cohort of adult patients who previously underwent planned left-sided colorectal resection with colorectal anastomosis using the conventional double-stapled technique (DST) during the years 2023-2025. Patients are identified through medical record review at participating centers using the same inclusion criteria as the prospective cohort, and outcome data are collected retrospectively for comparison.

Procedure: Double-stapled colorectal anastomosis

Interventions

Single-stapled colorectal anastomosis PROCEDURE

Construction of a colorectal anastomosis using a single-stapled technique, where the rectal staple line is excised and a purse-string suture is placed on the rectal stump and tied around the tip of a circular stapler, before completion of the anastomosis. The procedure is performed as part of routine clinical practice during planned left-sided colorectal resection.

Prospective single-stapled technique cohort

Double-stapled colorectal anastomosis PROCEDURE

Construction of a colorectal anastomosis using the conventional double-stapled technique, where the rectal stump is closed with a linear stapler and the anastomosis is completed using a circular stapler and without excision of the rectal staple line. The procedure is performed as part of standard surgical practice.

Retrospective double-stapled technique cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) undergoing planned left-sided colorectal resection with construction of a colorectal anastomosis, including left hemicolectomy, sigmoid resection, or partial mesorectal excision, for benign or malignant indications. Patients are treated as part of routine clinical care at participating centers. The study includes both a retrospective cohort of patients operated during 2023-2025 and a prospective cohort of consecutively included patients undergoing surgery after study initiation. In the prospective cohort, the intent is to perform a single-stapled colorectal anastomosis when technically feasible in all consenting patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Sahlgrenska University Hospital: collaborator
• Skane University Hospital: collaborator

Study Sites (5)

Östra Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Sunderby Hospital

Luleå, Sweden

RECRUITING

Skåne University Hospital

Malmo, Sweden

RECRUITING

Surgical Centre, Umeå University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oskar Grahn, MD, PhD

  Umea University / Region Vasterbotten

  PRINCIPAL INVESTIGATOR

• Martin Rutegård, MD, PhD

  Ostra Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Grahn, MD, PhD

CONTACT

+46907850000; oskar.grahn@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 18, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)