3-midline-ports Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Three Ports Placed in the Line Alba of the Abdomen (3-midline-ports Technique): an Alternative Approach for Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378819
• Other study ID #: UMH
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2011
• Last updated: June 21, 2011
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective cholecystectomy for symptomatic gallstones.

Exclusion Criteria:

• Diagnosis of acute cholecystitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 3-midline-ports laparoscopic cholecystectomy
The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
• 3-midline-ports laparoscopic cholecystectomy
Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The postoperative pain will be investigated 24 hours after surgery	24 hours	Yes