Quality of Life Measures After Single Access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.

February 24, 2012 updated by: MOHAMED ABDELLATIF, Mansoura University

Single Access Laparoscopic Cholecystectomy

This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a prospective study, two hundred fifty patients with symptomatic gall bladder stone were randomized to SALC or conventional laparoscopic cholecystectomy (CLC) (125 in each group). The primary endpoint of this study was to assess the total outcomes of quality of life using EuroQoL EQ-5D questionnaire. The secondary endpoints were postoperative pain, analgesia requirement and duration, operative time, perioperative complications, estimated blood loss, hospital stay, cosmoses outcomes and number of days required to return to normal activities.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mohamed Abdellatif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GALL BLADDER STONES

Exclusion Criteria:

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single ACCESS cholecystectomy
single ACCESS laparoscopic cholecystectomy
Procedure: surgery
single ACCESS laparoscopic cholecystectomy
Other Names:
  • SALC
  • GROUP I
Active Comparator: traditional
conventional laparoscopic cholecystectomy
Other: SURGERY
CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
Other Names:
  • CLC
  • GROUP II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QUALITY OF LIFE
Time Frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative
Quality of life was the primary endpoint of this study assessed by EuroQoL EQ-5D 9 questionnaire preoperatively, 1 week, 1 and 6 months after surgery. The EQ-5D is a validated questionnaire which consists of 2 pages: the EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The WQ-5D-descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 2 hours
(defined as the interval between the initial skin incision and skin closure)
2 hours
postoperative pain
Time Frame: 5 days
using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)
5 days
days to return to normal activity (RTNA)
Time Frame: 10 days
patients were contacted by phone every day until they are able to return to their normal daily works
10 days
COSMOSIS OUTCOMES
Time Frame: 1 AND 6 MONTHS
cosmetic outcomes 1 and 6 months after surgery using Patient and Observer Scar Assessment Scale (POSAS)(10), it comprises two distinct series of Visual Analogue Scale (VAS) instruments: one is self-assessed by the patient and one by an independent doctor, ranging from 1 (poor) to 10 (excellent)
1 AND 6 MONTHS
ANALGESIC REQUIRMENT
Time Frame: POSTOPERATIVE PERIOD
NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED
POSTOPERATIVE PERIOD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: ramadan ellithy, md, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 27, 2012

Last Update Submitted That Met QC Criteria

February 24, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Single access chOLECYSTECTOMY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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