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

Primary Purpose

Gallbladder Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cholecystectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all cases underwent single incision cholecystectomy

Exclusion Criteria:

  • none

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cholecystectomy

Arm Description

single incision laparoscopic cholecystectomy

Outcomes

Primary Outcome Measures

operative time
the time from starting the procedure till the skin closure

Secondary Outcome Measures

Full Information

First Posted
August 8, 2011
Last Updated
April 7, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01413633
Brief Title
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
Official Title
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cholecystectomy
Arm Type
Experimental
Arm Description
single incision laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
cholecystectomy
Other Intervention Name(s)
SILC
Intervention Description
single incision laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
operative time
Description
the time from starting the procedure till the skin closure
Time Frame
about 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all cases underwent single incision cholecystectomy Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DRAMADAN ELLITHY, M
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

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

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