Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Powered circular stapler | Device | — | UNRESOLVED |
| Three-row circular stapler | Device | — | UNRESOLVED |
| Two-row circular stapler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing colorectal cancer surgery with primary anastomosis
- description
- 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).
- interventionNames
- Device: Two-row circular stapler
- Device: Three-row circular stapler
- Device: Powered circular stapler
Primary outcomes (1)
- measure
- Anastomotic leakage
- timeFrame
- From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery
Secondary outcomes (3)
- measure
- Postoperative complications
- timeFrame
- From the date of surgery until the first occurrence of any postoperative complications, assessed up to 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available