NCT07696078

Brief Summary

The goal of this observational study is to learn about the long-term effects of cholecystectomy in patients over the age of 60 who take cholecystectomy to treat their acute cholecystitis). The main question it aims to answer is: Does frailty a risk factor for postcholecystectomy complications?

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

April 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

7 years

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

FrailtyGallbladder Diseases

Keywords

frailtyacute cholecystitis

Outcome Measures

Primary Outcomes (1)

  • postcholecystecomy complications

    through CD classification

    3 years

Study Arms (2)

frail patient

ACTIVE COMPARATOR
Procedure: cholecystectomy open

non frail patient

ACTIVE COMPARATOR
Procedure: cholecystectomy open

Interventions

cholecystectomy openPROCEDURE

frail following open cholecystectomy

frail patientnon frail patient

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FrailtyGallbladder DiseasesCholecystitis, Acute

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBiliary Tract DiseasesDigestive System DiseasesCholecystitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start

April 1, 2016

Primary Completion

April 1, 2023

Study Completion

April 1, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share