NCT02130245

Brief Summary

The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

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
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

April 21, 2014

Last Update Submit

April 7, 2015

Conditions

Acute Cholecystitis

Keywords

Laparoscopic cholecystectomyAcute cholecystitisEarlyDelayed

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Operative time is assessed in minutes ,

    1 DAY

Secondary Outcomes (4)

  • Perioperative complications

    5 weeks

  • Conversion rate

    1 DAY

  • hospital stay in days

    2 weeks

  • Period of giving antibiotics in days

    2 WEEKS

Study Arms (2)

Early cholecystectomy

ACTIVE COMPARATOR

Laparoscopic cholecystectomy well be done after the immediate admission

Procedure: Early cholecystectomy

Delayed cholecystectomy

ACTIVE COMPARATOR

Laparoscopic cholecystectomy after a period of conservative treatment

Procedure: Delayed cholecystectomy

Interventions

Early cholecystectomyPROCEDURE

Early laparoscopic cholecystectomy for acute cholecystitis after admission

Also known as: First group
Early cholecystectomy
Delayed cholecystectomyPROCEDURE

Laparoscopic cholecystectomy well be done after a period on conservation

Also known as: Second group
Delayed cholecystectomy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Proved acute cholecystitis clinical, radiologic

You may not qualify if:

  • Evidence of peritonitis
  • ASA III or IV
  • Previous upper abdominal surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia

Al Mansurah, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

mohamed e abdellatif, md

CONTACT

00201115051680surg_latif@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 21, 2014

First Posted

May 5, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)