Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery.
研究概览
简要总结
Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.
详细描述
Inguinal hernia is one of the most common treatable surgical conditions. The synthetic prostheses most often used in the inguinal area may in some cases create new clinical problems, such as foreign body sensation in the groin, discomfort, and abdominal wall stiffness, surgical site infections, migration of mesh and may affect procreation and sexual function, The cost and availability of mesh prostheses in smaller towns and underdeveloped regions proves to be a major hindrance. The requirement of the hour is to find a technique that is simple, cost effective, easy to perform, does not require extensive dissection or use of a foreign body, and also gives an acceptable recurrence rate without any major intra or post-operative complications and can be performed as a day care procedure to reduce the burden of cases in our community. A possible option for this is the Desarda method, presented in 2001, which uses an undetached strip of aponeurosis of the external oblique muscle instead of a mesh and has shown to have promising results in studies conducted so far. Several retrospective and randomized controlled trials have shown that local anaesthesia provides the best clinical and economic benefits to patients undergoing inguinal hernia repair. As there have been no studies till date comparing the outcomes for patients operated by these methods under local anaesthesia only, hence this study has been planned to assess if Desarda's technique is suitable to be used as a day care procedure with early return to normal activities after surgery, less post operative discomfort and minimum dose of analgesics and acceptable recurrence rates. This will help reduce the burden of the hospitals as these patients can be operated on a day care basis with minimal discomfort.
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
- Double (Participant, Investigator)
盲法说明
This will be a double blind trial .The patient will not be revealed about the technique being performed. The investigator who will follow up the patients post operatively in the out-patient clinic will also be blinded about the procedure performed on the patient.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Primary uncomplicated inguinal hernia
- •Male patients aged more than 18 years and less than 80 years
- •BMI less than 30kg/sq m
- •American Society of Anaesthesiologists (ASA) scale less than III
排除标准
- •Patients with recurrent, irreducible or strangulated inguinal hernias
- •Patients unable to interpret VAS or give consent
- •Patients participating in other clinical trials
- •Patients with infection in the inguinal region or epididymo-orchitis
- •Patients allergic to local anaesthetics
结局指标
主要结局
To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery.
时间窗: 7 days
Time taken to return to normal gait comfortably after the surgery is calculated based on the ability to walk comfortably or move freely after surgery, as measured by ability to bend, squat, kneel ,stoop.
次要结局
- Time required to return to work(30 days)
- Early recurrence within 6 months(6 months)
- Post operative pain(6 month)
- Presence of wound infection(6 months)
- Presence of seroma(30 days)
- Presence of haematoma(30 days)
- Loss or change in sensation in the operated groin(30 days)
- Foreign body sensation(6 months)
- Abdominal wall stiffness(6 months)
- Testicular edema/atrophy(6 months)
研究者
Dr. Prakash Kumar Sasmal
ASSOCIATE PROFESSOR, DEPT. OF GENERAL SURGERY
All India Institute of Medical Sciences, Bhubaneswar
