Comparison of two point fixation versus conventional fixation of polypropylene mesh in patients undergoing Lichtenstein repair for inguinal hernia: a pilot study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of postoperative groin discomfort
研究概览
简要总结
This randomised trial intends to evaluate the reduced rate of recurrence as well as improvement in the postoperative pain scores with of polypropylene mesh fixation at two ends of the inguinal canal (pubic tubercle and internal ring) to cover the posterior inguinal wall defect than conventional mesh fixation of Lichtenstein repair in adult patients with uncomplicated inguinal hernia. This study will recruit 45 patients in each intervention arm and follow them up for a period of 03 months following surgery for evaluation of the outcome measures. The postoperative groin discomfort will be considered the primary outcome measure in both the groups and duration of surgery, postoperative analgesia requirement, cost to the patient, chronic groin pain, and patient satisfaction will be evaluated as secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients > 18 years with uncomplicated primary inguinal hernia.
排除标准
- •ASA grade III and IV patients
- •Emergency hernioplasty
- •Recurrent inguinal hernia
- •Hernioplasty combined with orchiectomy or any additional procedure
- •Patients on immunosuppressive agents, steroid therapy, antipsychotic drugs
- •History of connective tissue disorder (eg: Rheumatoid arthritis, Scleroderma, Sjogren syndrome, Lupus erythematosus )
- •Patients having allergy to Paracetamol.
结局指标
主要结局
Incidence of postoperative groin discomfort
时间窗: To be measured at 06 hours, 24 hours. 07 days, and 30 days
次要结局
- Operational cost saving with two point mesh fixation technique(to be calculated in INR depending upon the usage of suture materials for each intervention)
- Duration of surgery(to be measured in minutes starting from the time of skin incision to last skin approximation suture)
- The total number of doses of analgesia required in postoperative period(From the postoperative recovery room upto the time of discharge from hospital)
- The length of postoperative hospital stay(To be measured in hours starting from the time of commencement of surgery up to the time of discharge)
- The incidence of chronic groin discomfort(To be measured at 03 months using visual analogue score)
- Local surgical site complications(To be evaluated clinically at the time of discharge, at 07 days, 30 days and 90 days)
- The quality of life and satisfaction score of the patients(To be evaluated at 03 months using Q-LES-Q-SF questionnaire and ECOG score)