Multiple Firings in Double-stapled Colorectal Anastomosis

NCT ID: NCT05498506

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-01-31

Brief Summary

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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

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Cai Zhenghao

Director, department of medical-engineering collaboration

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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MISC-DST

Identifier Type: -

Identifier Source: org_study_id

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