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CompletedNCT00732550Updated Jul 30, 2020

Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

An interventional study of Single trocar cholecystectomy and Standard laparoscopic cholecystectomy in Cholelithiasis, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Cholelithiasis

Keywords

  • cholelithiasis
  • cholecystitis
03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 197 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • morbid obesity with BMI>35
  • other gallbladder pathology like polyps or tumor
  • history of upper abdomen laparotomy
  • suspected choledocholithiasis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Single trocar

    Patients will undergo cholecystectomy by the single trocar approach

    Procedure: Single trocar cholecystectomy

  • Active comparator
    Standard lap cholecystectomy

    Standard lap choly

    Procedure: Standard laparoscopic cholecystectomy

Interventions

  • ProcedureSingle trocar cholecystectomy

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

  • ProcedureStandard laparoscopic cholecystectomy

    Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

06

What researchers measure

Primary outcomes

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

    Time frame: Continuous

Secondary outcomes

  1. To assess pain associated with the single trocar approach

    Time frame: Continuous

  2. To assess scar formation associated with single trocar approach

    Time frame: Continuous

07

Study locations

1 site
  • Hadassah Medical Organization Ein-Kerem campus
    Jerusalem, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00732550
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Aug 12, 2008
Start date
Jul 2008
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Jul 30, 2020

Study contacts

Yoav Mintz, MD
principal investigator · Hadassah Medical Organization
Avraham Rivkind, MD
study chair · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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