NCT00974194

Brief Summary

Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

8 years

First QC Date

September 8, 2009

Last Update Submit

October 12, 2018

Conditions

Cholecystolithiasis

Keywords

CholecystolithiasisCholecystectomyLaparoscopic surgerySingle port

Outcome Measures

Primary Outcomes (5)

  • Pain (value on a Visual Analog Scale)

    VAS

    1 day

  • Pain (value on a Visual Analog Scale)

    VAS

    2 days

  • Pain (value on a Visual Analog Scale)

    VAS

    1 month

  • Pain (value on a Visual Analog Scale)

    VAS

    3 month

  • Pain (value on a Visual Analog Scale)

    VAS

    1 year

Secondary Outcomes (8)

  • Complications

    1 month

  • Operative time

    Operative day

  • Cost analysis

    1 year

  • Cosmetic results

    1 month

  • Cosmetic results

    3 month

  • +3 more secondary outcomes

Study Arms (2)

SinglePort CCK

EXPERIMENTAL

CCK using Triport

Procedure: Single Trocar CCK

LS CCK

ACTIVE COMPARATOR

CCK using three or four trocars

Procedure: Standard CCK

Interventions

Single Trocar CCKPROCEDURE

CCK using Triport

SinglePort CCK
Standard CCKPROCEDURE

CCK using three or four ports

LS CCK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cholecystolithiasis
  • Age 18 to 75 y.o.
  • BMI \< 35

You may not qualify if:

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Related Links

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Pierre Allemann, MD

    CHV/CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of surgery

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 10, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

CH(1)