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

Not Applicable

Completed

• Conditions: Evidence of Cholecystectomy
• Interventions: Other: SURGERY

• Registration Number: NCT01412996
• Lead Sponsor: Mansoura University

Brief Summary

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

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• GALL BLADDER STONES

Exclusion Criteria

• ACUTE CHOLECYSTITIS
• PREVIOUS LAPAROTOMY
• ASA ABOVE 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single ACCESS cholecystectomy	SURGERY	single ACCESS laparoscopic cholecystectomy
traditional	SURGERY	conventional laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
QUALITY OF LIFE	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mohamed Abdellatif; 🇪🇬 Mansoura, Egypt