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NCT Number: NCT07643857

Circular Staplers and Anastomotic Leak After Colorectal Surgery

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.

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Key information

Conditions

Colorectal Cancer Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Anastomotic leakage

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

Secondary outcomes

  1. Postoperative complications

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

  2. Reintervention rate

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

  3. Postoperative length of stay

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Agnesi, MD

CONTACT

[email protected]

+390353063612

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

Other

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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