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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
Information provided by:
Mansoura University Identifier:
First received: January 6, 2011
Last updated: NA
Last verified: April 2010
History: No changes posted
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • operative time [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with symptomatic gallbladder stones

Exclusion Criteria:

  • acute cholecystitis cbd stones contraindications for laparoscopy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01272505

Mansoura Gastroenterology Surgical Center
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
  More Information Identifier: NCT01272505     History of Changes
Other Study ID Numbers: HSSILSVSCSILS 
Study First Received: January 6, 2011
Last Updated: January 6, 2011
Health Authority: Egypt: Mansoura Gastroenterology Surgical Center processed this record on December 05, 2016