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Conventional SILS vs Harmonic Scalpel SILS (SILS)

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ClinicalTrials.gov Identifier: NCT01272505
Recruitment Status : Unknown
Verified April 2010 by Mansoura University.
Recruitment status was:  Recruiting
First Posted : January 7, 2011
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Mansoura University

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.

Condition or disease Intervention/treatment Phase
Gallbladde Stones Procedure: converntional SILC Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

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



Primary Outcome Measures :
  1. operative time

Secondary Outcome Measures :
  1. complications


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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

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

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