Colorectal Cancer Postoperative Complications
Conditions
Keywords
Colorectal anastomosis, circular stapler, powered circular stapler, three-rwo circular stapler, two-row circular stapler, Tristaple
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.
Interventions
DEVICETwo-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.
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.
DEVICEPowered 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.
Sponsors
Azienda Ospedaliera Bolognini di Seriate Bergamo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leakage | From the date of surgery until the first occurrence of anastomotic leakage, assessed up to 30 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTStefano Agnesi, MD
Outcome results
None listed