NCT05770128

Brief Summary

The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 25, 2021

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

October 25, 2021

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.

    incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique.

    6 months

Interventions

laparoscopePROCEDURE

subserosal manipulation of gallbladder with laparoscope .

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

any patient admitted to surgical department wth age above 18 years old suffering \& diagnosed of chronic cholecystitis , symptomatic cholelithiasis

You may qualify if:

  • Adult with age of or above 18 years.
  • Diagnosis of chronic cholecystitis , symptomatic cholelithiasis

You may not qualify if:

  • Previous operation or adhesion
  • severe Acute Calculus pancreatitis
  • gall bladder cancer
  • Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
  • Recurrent cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystitis

Interventions

Laparoscopes

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Central Study Contacts

Ahmed M. Hussein, resident

CONTACT

Abdallah B. Abdallah, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed Mohamed Hussein

Study Record Dates

First Submitted

October 25, 2021

First Posted

March 15, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03