NCT07643857Not yet recruiting
Circular Staplers and Anastomotic Leak After Colorectal Surgery
Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 597 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Diseases
- Colorectal cancer
- NCT number
- NCT07643857
What you commit to
- Study type: Observational
- Planned participants: 597
- From Sept 2026 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing emergency surgery
- Patients undergoing additional surgical procedures during the same operation (e.g., cholecystectomy, liver resection, etc.)
Age
- Patients under 18 years of age
Other
- Patients with documented metastases at preoperative staging (cM+)
- Lack of informed consent
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.