Circular Staplers and Anastomotic Leak After Colorectal Surgery

NCT07643857 | Not Yet Recruiting

• 1 other identifier: PROTECT study
• Study Type: observational
• Target: 597
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Colorectal anastomosis; circular stapler; powered circular stapler; three-rwo circular stapler; two-row circular stapler; Tristaple

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery

Secondary Outcomes (3)

• Postoperative complications

  From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery

• Reintervention rate

  From the date of surgery until the first reintervention, assessed up to 30 days after index surgery

• Postoperative length of stay

  From date of surgery until the date of hospital discharge, average 1 week

Study Arms (1)

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; Device: Three-row circular stapler; Device: Powered circular stapler

Interventions

Two-row circular stapler DEVICE

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.

Patients undergoing colorectal cancer surgery with primary anastomosis

Powered circular stapler DEVICE

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.

Patients undergoing colorectal cancer surgery with primary anastomosis

Three-row circular stapler DEVICE

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.

Patients undergoing colorectal cancer surgery with primary anastomosis

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 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Bolognini di Seriate Bergamo: lead

Central Study Contacts

Stefano Agnesi, MD

CONTACT

+390353063612; stefano.agnesi@asst-bergamoest.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share