Conventional SILS vs Harmonic Scalpel SILS (SILS)

January 6, 2011 updated by: Mansoura University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura Gastroenterology Surgical Center
        • Contact:
        • Principal Investigator:
          • ahmed a elgeidie, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with symptomatic gallbladder stones

Exclusion Criteria:

  • acute cholecystitis cbd stones contraindications for laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: conventional SILC
Conventional method of single incision laparoscopic cholecystectomy
Procedure: converntional SILC
Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy
Active Comparator: HS-SILC
Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
operative time

Secondary Outcome Measures

Outcome Measure
complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • HSSILSVSCSILS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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