Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

NCT ID: NCT05789459

Last Updated: 2023-03-29

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

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-06-30

Brief Summary

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The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.

Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.

Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.

Detailed Description

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Conditions

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Distal Pancreatectomy Postoperative Pancreatic Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stapler group

closure with a stapler

Stapler

Intervention Type DEVICE

Stapler

Hand-sewn group

closure with suture

Suture

Intervention Type OTHER

Suture

Interventions

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Stapler

Stapler

Intervention Type DEVICE

Suture

Suture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy

Exclusion Criteria

* Incomplete medical records
* History of previous pancreatic operations
* Emergent operation
* Conversion to open pancreatectomy
* Receipt of wedge resection or other procedures
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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TingBo Liang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tingbo Liang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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DP-POPF

Identifier Type: -

Identifier Source: org_study_id

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