Back to results3-midline-ports Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
3-midline-ports laparoscopic cholecystectomy
3-midline-ports laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring laparoscopic cholecystectomy, Postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing elective cholecystectomy for symptomatic gallstones.
Exclusion Criteria:
- Diagnosis of acute cholecystitis
Sites / Locations
Outcomes
Primary Outcome Measures
Postoperative pain
The postoperative pain will be investigated 24 hours after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT01378819
First Posted
June 20, 2011
Last Updated
June 21, 2011
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT01378819
Brief Title
3-midline-ports Cholecystectomy
Official Title
Three Ports Placed in the Line Alba of the Abdomen (3-midline-ports Technique): an Alternative Approach for Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.
Detailed Description
The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laparoscopic cholecystectomy, Postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
3-midline-ports laparoscopic cholecystectomy
Intervention Description
The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
Intervention Type
Procedure
Intervention Name(s)
3-midline-ports laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The postoperative pain will be investigated 24 hours after surgery
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing elective cholecystectomy for symptomatic gallstones.
Exclusion Criteria:
Diagnosis of acute cholecystitis
12. IPD Sharing Statement
Learn more about this trial
3-midline-ports Cholecystectomy
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