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Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery

Sponsor
West China Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05657327
Collaborator
(none)
1,000
Enrollment
116.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery
    Actual Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jul 30, 2021
    Anticipated Study Completion Date :
    Sep 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group with postoperative complications

    Postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying
    Group without postoperative complications

    No postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying

    Outcome Measures

    Primary Outcome Measures

    1. Length of hospitalization [Entire perioperative period]

      Including the patient's perioperative hospital stay, postoperative time to discharge, and length of stay in the ICU

    2. Medical expenses [Entire perioperative period]

      Including the entire hospitalization period, medicine, surgery, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. All patients underwent laparoscopic pancreatic resections at the Department of Pancreatic Surgery of West China Hospital of Sichuan University and the Department of Minimal Invasive Surgery of Shangjin Nanfu Hospital between January 2014 and July

    3. All patients underwent laparoscopic pancreaticoduodenectomy (LPD), laparoscopic distal pancreatectomy (LDP), laparoscopic enucleation, laparoscopic middle pancreatectomy (LMP), laparoscopic duodenum-preserving resection of head of pancreas (LDPRHP), or laparoscopic Frey procedure.

    4. Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely.

    Exclusion Criteria:

    1. Patients converted to laparotomy

    2. Patients underwent total pancreatectomy

    3. Patients underwent pancreatic pseudocyst drainage management

    4. Patients underwent pancreas biopsy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • West China Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinrui Zhu，MD, Director, West China Hospital
    ClinicalTrials.gov Identifier:
    NCT05657327
    Other Study ID Numbers:
    • 126059
    First Posted:
    Dec 20, 2022
    Last Update Posted:
    Dec 20, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Gastroparesis
    Fistula
    Postoperative Complications
    Postoperative Hemorrhage

    Study Results

    No Results Posted as of Dec 20, 2022