Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Sponsor
B.P. Koirala Institute of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04994171
Collaborator
(none)
74
1
11
6.7

Study Details

Study Description

Brief Summary

The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention and validate Nassar Scale.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Laparoscopic cholecystectomy is the commonly performed procedure in our institute. Laparosopic cholecystectomy is high variable surgery ranging from simple routine operation to difficult surgery leading to increased morbidity and mortality. The majority of previous scores use a combination of pre-operative and operative data and were produced in studies that were limited by retrospective data, small sample sizes and lack of external validation.

    Very few intraoperative difficulty grading scale was published and none are widely used in clinical practice. So operative grading scale will have advantages of assisting in intra-operative strategy and planning, allowing comparison across different research studies, facilitating risk adjustment for surgical outcomes and providing an aid in training surgeons and monitoring of training progression.

    The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS
    Actual Study Start Date :
    Jul 1, 2020
    Actual Primary Completion Date :
    Jan 30, 2021
    Actual Study Completion Date :
    Jun 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Laproscopic cholecystectomy Conversion to open with Nassar Grade [30 day]

      Laproscopic cholecystectomy converted to open with Nassar grade ie chance of conversion to open in higher Nassar grade(difficult laparoscopic cholecystectomy)

    2. Duration of Surgery [30 day]

    3. Introperative Complication with Nassar Grade [30 day]

      Complication like biliary spillage, stone spillage and bleeding with higher Nassar grade (difficult laparoscopic cholecystectomy)

    Secondary Outcome Measures

    1. Total length of stay [30 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All patients undergoing laparoscopic cholecystectomy
    Exclusion Criteria:
    • CBD Stone

    • Malignancy of Extrahepatic biliary tree

    • Cholecystectomy as a part of other surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nirmal Prasad sah Dharān Bāzār Province 1 Nepal

    Sponsors and Collaborators

    • B.P. Koirala Institute of Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nirmal Prasad Sah, Assistant Professor, B.P. Koirala Institute of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04994171
    Other Study ID Numbers:
    • 1758/020
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nirmal Prasad Sah, Assistant Professor, B.P. Koirala Institute of Health Sciences

    Study Results

    No Results Posted as of Aug 9, 2021