Multiple Firings in Double-stapled Colorectal Anastomosis

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT05498506
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief Summary

Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2022-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 1. carcinoma of rectum confirmed by histopathological evaluation;
• 2. tumor located in the mid-low rectum (less than 10cm from the anal verge);
• 3. performance of DST anastomosis;
• 4. pelvic MRI obtained within 14 days before surgery.

Exclusion Criteria

• 1. other anastomotic techniques (e.g., trans-anal rectal excision);
• 2. Hartmann's operation or other procedures without anastomosis;
• 3. the number of linear stapler cartridges was not traceable in the operative report.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the number of linear stapler cartridges	during surgery	the number of linear stapler cartridges used during DST anastomosis

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China