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

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

Detailed Description
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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.

Official Title
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Single Access Laparoscopic Cholecystectomy

Conditions
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Evidence of Cholecystectomy

Intervention / Treatment
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* Procedure: surgery
* Other: SURGERY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GALL BLADDER STONES Exclusion Criteria: ACUTE CHOLECYSTITIS PREVIOUS LAPAROTOMY ASA ABOVE 3
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single ACCESS cholecystectomy<br>single ACCESS laparoscopic cholecystectomy | Procedure: surgery<br>* single ACCESS laparoscopic cholecystectomy<br>* Other names: GROUP I;|
| Active Comparator: traditional<br>conventional laparoscopic cholecystectomy | Other: SURGERY<br>* CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY<br>* Other names: GROUP II;|

What is the study measuring?
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Primary Outcome Measures

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