NCT04994171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

July 29, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

SurgeryLaparoscopicCholecystectomyCholecystitis

Outcome Measures

Primary Outcomes (3)

  • Laproscopic cholecystectomy Conversion to open with Nassar Grade

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

    30 day

  • Duration of Surgery

    30 day

  • Introperative Complication with Nassar Grade

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

    30 day

Secondary Outcomes (1)

  • Total length of stay

    30 day

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital patients

You may qualify if:

  • All patients undergoing laparoscopic cholecystectomy

You may not qualify if:

  • CBD Stone
  • Malignancy of Extrahepatic biliary tree
  • Cholecystectomy as a part of other surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nirmal Prasad sah

Dharān, Koshi, Nepal

Location

Related Publications (3)

  • Chandio A, Timmons S, Majeed A, Twomey A, Aftab F. Factors influencing the successful completion of laparoscopic cholecystectomy. JSLS. 2009 Oct-Dec;13(4):581-6. doi: 10.4293/108680809X1258998404560.

    PMID: 20202401BACKGROUND
  • Ahmed N, Hassan MU, Tahira M, Samad A, Rana HN. Intra-Operative Predictors of difficult cholecystectomy and Conversion to Open Cholecystectomy - A New Scoring System. Pak J Med Sci. 2018 Jan-Feb;34(1):62-66. doi: 10.12669/pjms.341.13302.

    PMID: 29643880BACKGROUND
  • Jameel SM, Bahaddin MM, Mohammed AA. Grading operative findings at laparoscopic cholecystectomy following the new scoring system in Duhok governorate: Cross sectional study. Ann Med Surg (Lond). 2020 Oct 23;60:266-270. doi: 10.1016/j.amsu.2020.10.035. eCollection 2020 Dec.

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 6, 2021

Study Start

July 1, 2020

Primary Completion

January 30, 2021

Study Completion

June 1, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations