Conventional SILS vs Harmonic Scalpel SILS

NCT ID: NCT01272505

Last Updated: 2011-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Gallbladde Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional SILC

Conventional method of single incision laparoscopic cholecystectomy

Group Type PLACEBO_COMPARATOR

converntional SILC

Intervention Type PROCEDURE

Harmonic scalpel Single incision laparoscopic cholecystectomy

Intervention Type PROCEDURE

HS-SILC

Group Type ACTIVE_COMPARATOR

Harmonic scalpel Single incision laparoscopic cholecystectomy

Intervention Type PROCEDURE

Interventions

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converntional SILC

Intervention Type PROCEDURE

Harmonic scalpel Single incision laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with symptomatic gallbladder stones

Exclusion Criteria

* acute cholecystitis cbd stones contraindications for laparoscopy
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Locations

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Mansoura Gastroenterology Surgical Center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed a elgeidie, md

Role: CONTACT

0020105290111 ext. 0

Facility Contacts

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ahmed a elgeidie, md

Role: primary

0020105290111 ext. 0

Other Identifiers

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HSSILSVSCSILS

Identifier Type: -

Identifier Source: org_study_id

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