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

Mansoura University250 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Evidence of Cholecystectomy

Interventions

surgeryPROCEDURE

single ACCESS laparoscopic cholecystectomy

SURGERYOTHER

CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * GALL BLADDER STONES Exclusion Criteria: * ACUTE CHOLECYSTITIS * PREVIOUS LAPAROTOMY * ASA ABOVE 3

Locations (1)

Mohamed Abdellatif

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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.

Time frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative

Secondary Outcomes

operative time

(defined as the interval between the initial skin incision and skin closure)

Time frame: 2 hours

postoperative pain

using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)

Time frame: 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

Time frame: 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)

Time frame: 1 AND 6 MONTHS

ANALGESIC REQUIRMENT

NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED

Time frame: POSTOPERATIVE PERIOD

Data from ClinicalTrials.gov

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