Circular Staplers and Anastomotic Leak After Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Two-row circular stapler, Three-row circular stapler, Powered circular stapler.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Postoperative Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of the Impact of New Circular Stapler Technology in Colorectal Anastomosis: the PROTECT Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Anastomotic leakage [Time frame: From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery]
Secondary outcome measures (3)
- Postoperative complications [Time frame: 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]
- Postoperative length of stay [Time frame: From date of surgery until the date of hospital discharge, average 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07643857 · PROTECT study