Evidence of Cholecystectomy
Conditions
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.
Interventions
PROCEDUREsurgery
single ACCESS laparoscopic cholecystectomy
OTHERSURGERY
CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* GALL BLADDER STONES
Exclusion criteria
* ACUTE CHOLECYSTITIS * PREVIOUS LAPAROTOMY * ASA ABOVE 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed