NCT00689663

Brief Summary

Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection. Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

1.6 years

First QC Date

May 26, 2008

Last Update Submit

May 29, 2008

Conditions

Cholecystectomy

Keywords

cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate

    30 days

Secondary Outcomes (1)

  • surgical complications

    3 months

Study Arms (3)

1

ACTIVE COMPARATOR

Dissection staring at the triangle of calots. Dissection with electrocautery.

Procedure: Laparoscopic cholecystectomy

2

ACTIVE COMPARATOR

Dissection as fundus first with electrocautery.

Procedure: Laparoscopic cholecystectomy

3

ACTIVE COMPARATOR

Dissection as fundus first with ultrasonic dissection.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Randomized to three arm.

Also known as: Randomised study.
123

Eligibility Criteria

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

You may qualify if:

  • laparoscopic cholecystectomy

You may not qualify if:

  • age \>Z65
  • ASA \>3
  • obesity
  • previous extensive gastrointestinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sundsvall Hospital

Sundsvall, Sundsvall, se-85641, Sweden

Location

Related Publications (1)

  • Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.

    PMID: 15880649BACKGROUND

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Leif A Israelsson, MD,PhD

    Umea University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2008

First Posted

June 3, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

SE(1)