NCT01413633

Brief Summary

The investigators describe a novel technique for GB fundus retraction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

August 8, 2011

Last Update Submit

April 7, 2015

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • operative time

    the time from starting the procedure till the skin closure

    about 3 hours

Study Arms (1)

cholecystectomy

EXPERIMENTAL

single incision laparoscopic cholecystectomy

Procedure: cholecystectomy

Interventions

cholecystectomyPROCEDURE

single incision laparoscopic cholecystectomy

Also known as: SILC
cholecystectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all cases underwent single incision cholecystectomy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • DRAMADAN ELLITHY, M

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 10, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)