Acute Cholecystitis: Early Versus Delayed Laparoscopic Ch... | NCT02130245

Studies
Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study

NCT02130245

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Apr 8, 2015Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Acute Cholecystitis

Interventions

Early cholecystectomy
Delayed cholecystectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Apr 21, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Early cholecystectomy	Procedure	Early laparoscopic cholecystectomy for acute cholecystitis after admission	Early cholecystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative time	Operative time is assessed in minutes ,	1 DAY

Secondary Outcomes

Measure	Description	Time Frame
Perioperative complications	Intraoperative complications like bleeding , injury,	5 weeks
Conversion rate	Conversion rate from laparoscopic to open and reason of conversion.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Proved acute cholecystitis clinical, radiologic

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed e abdellatif, md	Contact	00201115051680		surg_latif@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia	Recruiting	Al Mansurah			Egypt

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D041881	Cholecystitis, Acute

Ancestor Terms

ID	Term
D002764	Cholecystitis
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided