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Conventional SILS vs Harmonic Scalpel SILS (SILS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Mansoura University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272505
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  Purpose
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.

Condition Intervention
Gallbladde Stones Procedure: converntional SILC Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • operative time

Secondary Outcome Measures:
  • complications

Estimated Enrollment: 137
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with symptomatic gallbladder stones

Exclusion Criteria:

  • acute cholecystitis cbd stones contraindications for laparoscopy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272505


Contacts
Contact: ahmed a elgeidie, md 0020105290111 ext 0 ahmedraoaf@mans.edu.eg

Locations
Egypt
Mansoura Gastroenterology Surgical Center Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: ahmed a elgeidie, md    0020105290111 ext 0    ahmedraoaf@mans.edu.eg   
Principal Investigator: ahmed a elgeidie, md         
Sponsors and Collaborators
Mansoura University
  More Information

ClinicalTrials.gov Identifier: NCT01272505     History of Changes
Other Study ID Numbers: HSSILSVSCSILS
First Submitted: January 6, 2011
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
Last Verified: April 2010