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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MOHAMED ABDELLATIF, Mansoura University

ClinicalTrials.gov Identifier:

NCT01412996

First received: August 4, 2011

Last updated: February 24, 2012

Last verified: February 2012

History of Changes

Purpose

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

Condition	Intervention
Evidence of Cholecystectomy	Procedure: surgery Other: SURGERY


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Single Access Laparoscopic Cholecystectomy

Further study details as provided by Mansoura University:

Primary Outcome Measures:

QUALITY OF LIFE [ Time Frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

operative time [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
(defined as the interval between the initial skin incision and skin closure)
postoperative pain [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)
days to return to normal activity (RTNA) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
patients were contacted by phone every day until they are able to return to their normal daily works
COSMOSIS OUTCOMES [ Time Frame: 1 AND 6 MONTHS ] [ Designated as safety issue: Yes ]
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)
ANALGESIC REQUIRMENT [ Time Frame: POSTOPERATIVE PERIOD ] [ Designated as safety issue: Yes ]
NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED


Enrollment:	250
Study Start Date:	November 2009
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

GALL BLADDER STONES

Exclusion Criteria:

ACUTE CHOLECYSTITIS
PREVIOUS LAPAROTOMY
ASA ABOVE 3

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412996

Locations


Egypt
Mohamed Abdellatif
Mansoura, Egypt, 35516

Sponsors and Collaborators

Mansoura University

Investigators


Study Chair:	RAMADAN ELLITHY, MD	Mansoura University

More Information

No publications provided


Responsible Party:	MOHAMED ABDELLATIF, ASS. PROF., Mansoura University
ClinicalTrials.gov Identifier:	NCT01412996 History of Changes
Other Study ID Numbers:	Single access chOLECYSTECTOMY
Study First Received:	August 4, 2011
Last Updated:	February 24, 2012
Health Authority:	Egypt: Ministry of Health and Population

ClinicalTrials.gov processed this record on March 01, 2015

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