NCT00732550

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 30, 2020

Status Verified

April 1, 2016

Enrollment Period

10.2 years

First QC Date

August 3, 2008

Last Update Submit

July 28, 2020

Conditions

Cholelithiasis

Keywords

cholelithiasischolecystitis

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.

    Continuous

Secondary Outcomes (2)

  • To assess pain associated with the single trocar approach

    Continuous

  • To assess scar formation associated with single trocar approach

    Continuous

Study Arms (2)

Single trocar

EXPERIMENTAL

Patients will undergo cholecystectomy by the single trocar approach

Procedure: Single trocar cholecystectomy

Standard lap cholecystectomy

ACTIVE COMPARATOR

Standard lap choly

Procedure: Standard laparoscopic cholecystectomy

Interventions

Single trocar cholecystectomyPROCEDURE

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

Single trocar
Standard laparoscopic cholecystectomyPROCEDURE

Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Standard lap cholecystectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization Ein-Kerem campus

Jerusalem, Israel

Location

MeSH Terms

Conditions

CholelithiasisCholecystitis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Yoav Mintz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Avraham Rivkind, MD

    Hadassah Medical Organization

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2008

First Posted

August 12, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

July 30, 2020

Record last verified: 2016-04

Locations

IL(1)