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Circular Staplers and Anastomotic Leak After Colorectal Surgery

NCT07643857 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 597

Last updated 2026-06-12

No results posted yet for this study

Summary

The goal of this observational study is to evaluate whether different circular stapling devices influence the success of the surgical connection between the bowel ends after colorectal cancer surgery in patients undergoing colorectal resection using different stapling devices.

The main question this study aims to answer is whether different circular stapling devices affect the risk of a leak developing at the site where the bowel is reconnected after colorectal cancer surgery.

Researchers will compare three types of circular stapling devices commonly used in clinical practice (two-row, three-row, and powered circular staplers) to determine whether they are associated with different risks of leakage at the site where the bowel is reconnected after colorectal cancer surgery.

Participants will receive standard medical care. Taking part in this study will not affect their treatment, and no additional procedures, tests, or visits are required as part of the study.

Conditions

  • Colorectal Cancer Postoperative Complications

Interventions

DEVICE

Two-row circular stapler

Two-row circular stapler: circular stapling device creating a colorectal anastomosis using two concentric rows of staples. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.

DEVICE

Three-row circular stapler

Three-row circular stapler: circular stapling device creating a colorectal anastomosis using three concentric rows of staples with graduated staple heights designed to optimize tissue compression and sealing. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.

DEVICE

Powered circular stapler

Powered circular stapler: electrically powered circular stapling device used to create a colorectal anastomosis. The powered mechanism is designed to standardize tissue compression and stapler firing while reducing operator-dependent variability. The device is used according to routine clinical practice during colorectal resection with primary anastomosis.

Sponsors & Collaborators

  • Azienda Ospedaliera Bolognini di Seriate Bergamo

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643857 on ClinicalTrials.gov