Circular Staplers and Anastomotic Leak After Colorectal Surgery (PROTECT)

June 10, 2026 updated by: Azienda Ospedaliera Bolognini di Seriate Bergamo

Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients undergoing elective colorectal resection with primary colorectal anastomosis for colorectal cancer at participating centers. Participants will be recruited from multiple italian and international hospitals involved in this multicenter observational study.

Description

Inclusion Criteria:

  • Adult patients (18 years or older)
  • Patients undergoing elective surgery, either open or minimally invasive (laparoscopic or robotic), for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row CS, three-row CS, PCS).

Exclusion Criteria:

  • Patients undergoing emergency surgery
  • Patients undergoing additional surgical procedures during the same operation (e.g., cholecystectomy, liver resection, etc.)
  • Patients with documented metastases at preoperative staging (cM+)
  • Patients under 18 years of age
  • Lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing colorectal cancer surgery with primary anastomosis
Patients undergoing elective surgery for anterior rectal resection, sigmoid resection, or left hemicolectomy for colorectal cancer with concomitant colorectal anastomosis (Knight-Griffen technique) using one of the circular stapler types under investigation (two-row circular stapler, three-row circular stapler, powered circular stapler).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anastomotic leakage
Time Frame: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
Reintervention rate
Time Frame: From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
From the date of surgery until the first reintervention, assessed up to 30 days after index surgery
Postoperative length of stay
Time Frame: From date of surgery until the date of hospital discharge, average 1 week
From date of surgery until the date of hospital discharge, average 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTECT study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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