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OpenTrials
Completed

NCT Number: NCT05498506

Multiple Firings in Double-stapled Colorectal Anastomosis

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital

Shanghai, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the number of linear stapler cartridges

    Time frame: during surgery

    the number of linear stapler cartridges used during DST anastomosis

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Official study title

Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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