Conventional SILS vs Harmonic Scalpel SILS | NCT01272505

Studies
Conventional SILS vs Harmonic Scalpel SILS

NCT01272505

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Jan 7, 2011Estimated

Enrollment

137Estimated

Phase

Not Applicable

Conditions

Gallbladde Stones

Interventions

converntional SILC
Harmonic scalpel Single incision laparoscopic 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 2010

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 6, 2011

First Posted Date

Jan 7, 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

Jan 6, 2011

Last Update Posted Date

Jan 7, 2011Estimated

Description Module

Brief Summary

Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.

Detailed Description

Not provided

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

137Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional SILC	Placebo Comparator	Conventional method of single incision laparoscopic cholecystectomy	Procedure: converntional SILC Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy
HS-SILC	Active Comparator		Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
converntional SILC	Procedure		conventional SILC
Harmonic scalpel Single incision laparoscopic cholecystectomy

Measure	Description	Time Frame
operative time

Measure	Description	Time Frame
complications

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with symptomatic gallbladder stones

Exclusion Criteria:

acute cholecystitis cbd stones contraindications for laparoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed a elgeidie, md	Contact	0020105290111	0	ahmedraoaf@mans.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura Gastroenterology Surgical Center	Recruiting	Al Mansurah	Dakahlia Governorate	35516	Egypt