A Novel Technique For Gall Bladder Fundus Retraction In S... | NCT01413633

Studies
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy

NCT01413633

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Apr 8, 2015Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Gallbladder Diseases

Interventions

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 8, 2011

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

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 investigators describe a novel technique for GB fundus retraction.

Detailed Description

few methods are available for gall bladder (GB) retraction in SILC to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way to retract the gall bladder fundus.

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cholecystectomy	Experimental	single incision laparoscopic cholecystectomy	Procedure: cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecystectomy	Procedure	single incision laparoscopic cholecystectomy	cholecystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
operative time	the time from starting the procedure till the skin closure	about 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all cases underwent single incision cholecystectomy

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DRAMADAN ELLITHY, M	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002763	Cholecystectomy

Ancestor Terms

ID	Term
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided