Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

NCT ID: NCT00732550

Last Updated: 2020-07-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Cholelithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single trocar

Patients will undergo cholecystectomy by the single trocar approach

Group Type EXPERIMENTAL

Single trocar cholecystectomy

Intervention Type PROCEDURE

Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach

Standard lap cholecystectomy

Standard lap choly

Group Type ACTIVE_COMPARATOR

Standard laparoscopic cholecystectomy

Intervention Type PROCEDURE

Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Interventions

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Single trocar cholecystectomy

Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach

Intervention Type PROCEDURE

Standard laparoscopic cholecystectomy

Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-60
* symptomatic cholelithiasis
* ASA 1-2

Exclusion Criteria

* pregnancy
* morbid obesity with BMI\>35
* other gallbladder pathology like polyps or tumor
* history of upper abdomen laparotomy
* suspected choledocholithiasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoav Mintz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Avraham Rivkind, MD

Role: STUDY_CHAIR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization Ein-Kerem campus

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Single trocar HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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