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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single ACCESS cholecystectomy | Active Comparator | single ACCESS laparoscopic cholecystectomy |
|
| traditional | Active Comparator | conventional laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure | single ACCESS laparoscopic cholecystectomy |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RAMADAN ELLITHY, MD | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Abdellatif | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| SURGERY | Other | CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY |
|
|
| 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 |