NCT05498506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

August 10, 2022

Last Update Submit

February 22, 2024

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • the number of linear stapler cartridges

    the number of linear stapler cartridges used during DST anastomosis

    during surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent Laparoscopic anterior resection for mid-low rectal cancer at Ruijin Hospital, Shanghai, People's Republic of China, between 2016 and 2021.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, department of medical-engineering collaboration

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)