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Multiple Firings in Double-stapled Colorectal Anastomosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05498506
Enrollment
350
Registered
2022-08-12
Start date
2022-12-01
Completion date
2023-01-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

None listed

Sponsors

Shanghai Minimally Invasive Surgery Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the number of linear stapler cartridgesduring surgerythe number of linear stapler cartridges used during DST anastomosis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026