3-midline-ports Cholecystectomy | NCT01378819

Studies
3-midline-ports Cholecystectomy

NCT01378819

Sponsor

Universidad Miguel Hernandez de Elche

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Postoperative Pain

Interventions

3-midline-ports laparoscopic cholecystectomy
3-midline-ports laparoscopic cholecystectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 20, 2011

First Submission Date that Met QC Criteria

Jun 21, 2011

First Posted Date

Jun 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3-midline-ports laparoscopic cholecystectomy	Procedure	The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
3-midline-ports laparoscopic cholecystectomy	Procedure	Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	The postoperative pain will be investigated 24 hours after surgery	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective cholecystectomy for symptomatic gallstones.

Exclusion Criteria:

Diagnosis of acute cholecystitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided