NCT01378819

Brief Summary

The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
Last Updated

June 22, 2011

Status Verified

February 1, 2010

Enrollment Period

10 months

First QC Date

June 20, 2011

Last Update Submit

June 21, 2011

Conditions

Keywords

laparoscopic cholecystectomyPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    The postoperative pain will be investigated 24 hours after surgery

    24 hours

Interventions

The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective cholecystectomy for symptomatic gallstones.

You may not qualify if:

  • Diagnosis of acute cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 22, 2011

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 22, 2011

Record last verified: 2010-02