NCT04569370

Brief Summary

Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

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

September 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 24, 2020

Last Update Submit

September 24, 2020

Conditions

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

    1 year

Study Arms (2)

Scoring Factor

Intervention: Procedure: Laparoscopic cholecystectomy

Procedure: Laparoscopic Cholecystectomy

Difficult criteria

Intervention: Procedure: Laparoscopic cholecystectomy

Procedure: Laparoscopic Cholecystectomy

Interventions

Surgical removal of Gall bladder using laparoscopy

Difficult criteriaScoring Factor

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals

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

Related Publications (1)

  • Veerank N, Togale MD. VALIDATION OF A SCORING SYSTEM TO PREDICT DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY: A ONE-YEAR CROSS-SECTIONAL STUDY. J West Afr Coll Surg. 2018 Jan-Mar;8(1):23-39.

    PMID: 30899702BACKGROUND

MeSH Terms

Conditions

CholecystitisBronchiolitis Obliterans Syndrome

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Salah Ibrahim, Prof

    Professor at faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Abobakr Mahfouz Abobakr, Resident

CONTACT

Besher Abo-el soud, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 29, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

September 29, 2020

Record last verified: 2020-09