Single Access Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- QUALITY OF LIFE
研究概览
简要总结
This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GALL BLADDER STONES
排除标准
- •ACUTE CHOLECYSTITIS
- •PREVIOUS LAPAROTOMY
- •ASA ABOVE 3
结局指标
主要结局
QUALITY OF LIFE
时间窗: 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.
次要结局
- operative time(2 hours)
- postoperative pain(5 days)
- days to return to normal activity (RTNA)(10 days)
- COSMOSIS OUTCOMES(1 AND 6 MONTHS)
- ANALGESIC REQUIRMENT(POSTOPERATIVE PERIOD)
研究者
MOHAMED ABDELLATIF
ASS. PROF.
Mansoura University