Comparison of Open Vs Laparoscopic Repair of Uncomplicated VentralHernia Using Disease Specific Quality Of Life Index
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Laparoscopic ventral hernia repair improves quality-of-life as compared to open repair
研究概览
简要总结
After taking written informed consent with patients satisfying
inclusion criteria, the patient’s data like patient’s details, history & examination finding ,
values of routine laboratory investigations and preoperative HerQLes score will be recorded
in the Case Record Performa (CRF). The patients will be allocated randomly into one of the
two groups, Group A (Open Repair) and B (Laparoscopic Repair). Pre operatively patients
will be administered a single dose antibiotic prophylaxis of Ceftriaxone intravenous 1 gm, one
hour before surgery. The patients will be administered Intra-Venous Paracetamol (1gm) at
q8hr and Intra-Venous Diclofenac (Aq) 75 mg at q12hr on the immediate postoperative
period (POD-0). They will be switched to Tablet Diclofenac 50mg PO q8hr from POD1
onwards. The number of days of requirement of Tablet Diclofenac 50mg PO q8hr or any
other additional analgesia requirement will be noted down. Visual Analogue Scale (VAS)
for pain will be recorded at 24 hours postoperatively. The patients will be followed up at
POD7 (1st week) ,4th week and 8th week in the General Surgery Outpatient Department
(OPD) as well as over telephone, for recording HerQLes score for Quality of Life
postoperatively, VAS score for pain/discomfort and for development of any complications
like Seroma, Surgical Site Infection, and Recurrence etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-60 years ii.
- •Patient give informed written consent iii.
- •Ventral hernia less than 10cm in diameter iv.
- •Undergoing elective surgery for ventral hernia.
排除标准
- •Pregnant women ii.
- •Patients with complicated ventral hernia (pain, incarcerated, strangulated etc) iii.
- •Patients with multiple abdominal scars iv.
- •Patients with abdominal wall infection v.
- •Patients on immunosuppressive agents or suffering from immunosuppressive disorders vii.
- •History of connective tissue disorder (e.g.: Rheumatoid arthritis, Scleroderma, Sjogren syndrome, Lupus erythematosus etc ).
结局指标
主要结局
Laparoscopic ventral hernia repair improves quality-of-life as compared to open repair
时间窗: 2 month follow up for each patients postoperatively. | Total duration of study is 12 to 18 months.
postoperatively.
时间窗: 2 month follow up for each patients postoperatively. | Total duration of study is 12 to 18 months.
次要结局
- Laparoscopic ventral hernia repair also improves the following parameter as compared to(open repair postoperatively.)