NCT03718572

Brief Summary

Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 23, 2018

Last Update Submit

October 23, 2018

Conditions

Evaluation Studies

Outcome Measures

Primary Outcomes (1)

  • Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy

    Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy

    6 monthes

Study Arms (2)

Scoring factors

Procedure: Laparoscopic cholecystectomy

Difficulty criteria

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Surgical removal of Gall bladder using laparoscopy

Difficulty criteriaScoring factors

Eligibility Criteria

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

Adults male and female age of or above 18 years

You may qualify if:

  • Adults male and female age of or above 18 years
  • Symptomatic chronic calculous cholecystitis
  • Ultrasound confirmed Gall bladder stones

You may not qualify if:

  • Complicated chronic calculous cholecystitis
  • Malignant Gall bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

AbdElRhman Mohamed, Dr

CONTACT

0201065787845elabassi1001@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 24, 2018

Study Start

January 1, 2019

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Locations

EG(1)