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Conventional SILS vs Harmonic Scalpel SILS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Mansoura University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01272505
First received: January 6, 2011
Last updated: NA
Last verified: April 2010
History: No changes posted
  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
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

  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with symptomatic gallbladder stones

Exclusion Criteria:

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

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on June 13, 2013