NCT05606029

Brief Summary

A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

October 25, 2022

Last Update Submit

November 2, 2022

Conditions

Gallbladder Malignant Neoplasm

Keywords

Gallbladder,PolypGallstonesMalignancyPerforation

Outcome Measures

Primary Outcomes (1)

  • Diagnosed with Gallbladder malignancy

    Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy

    For one year

Study Arms (1)

Patients who underwent cholecystectomy for benign conditions

In those who underwent cholecystectomy for benign conditions, the histopathological analysis showed the malignancy.

Procedure: Cholecystectomy, extended cholecystectomy

Interventions

Cholecystectomy, extended cholecystectomyPROCEDURE

Cholecystectomy and histopathological evaluation

Also known as: Histopathological evaluation of the specimen
Patients who underwent cholecystectomy for benign conditions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients who underwent cholecystectomy for benign conditions like gall stones, polyps,. Etc,.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmania General Hospital

Hyderabad, Telangana, 500012, India

Location

MeSH Terms

Conditions

Gallbladder NeoplasmsPolypsGallstonesNeoplasms

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCholelithiasisCholecystolithiasisCalculi

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sathaiah Dadi, MS Gen Surg

    Osmania Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS General Surgery, Principal investigator

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 4, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)