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临床试验/CTRI/2025/03/081717
CTRI/2025/03/081717尚未招募4 期

To Compare the Perioperative outcomes of Trans Abdominal Pre-Peritoneal Repair Procedure (TAPP) Versus Lichtenstein Open Repair in Treatment of Primary Unilateral Inguinal Hernia in Male patients: A Randomised Control Trail in a Tertiary care Centre of Eastern Uttar Pradesh

Dr Budarapu Vishnu Vardhan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Operative time.

研究概览

简要总结

Inguinal hernias are among the most common surgical conditions worldwide, with millions of procedures performed annually. The choice of surgical technique significantly impacts patient outcomes making it a critical area of research. Lichtenstein open mesh repair is considered the gold standard for open repair. A laparoscopic repair Trans Abdominal Pre peritoneal Repair offers potential advantages. Existing studies on Trans Abdominal Pre peritoneal repair versus Lichtenstein repair are often limited by heterogenicity  small sample sizes and observational designs. A randomized controlled trial ensures robust unbiased comparison of these techniques providing high quality evidence to guide clinical practice. This study will be conducted at the Department of General Surgery  All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with advanced medical facilities and a high volume of surgical cases providing a suitable environment for conducting a randomized controlled trial. The setting ensures access to a diverse patient population undergoing hernia repair allowing for robust data collection and analysis. This is a prospective single blinded single centred randomized controlled trial designed to compare the outcomes of Trans abdominal pre peritoneal repair procedure versus Lichtenstein open repair. Participants will be patients visiting surgery out patient department taking into account the inclusion and exclusion criteria. Patients will be randomized into one of the two study groups, Group A Trans abdominal pre peritoneal repair and Group B Lichtenstein open repair alternatively in order of arrival in outpatient department. All the cases of both group A and group B will be operated by surgeons with equivalent experience of minimum 5 years. Patient will be followed for 180 days. In this duration patient will be assessed on day of discharge on the day when patient revisit for suture removal, 90 days, 180 days after surgery. In addition patient will be assessed in between if any complications arise. The key outcomes that will be assessed include operative time duration of hospital stay time to return to normal activities or work  incidence of seroma hematoma surgical site infections during hospital stay incidence and severity of chronic pain at 3 months and 6 months post operatively and surgical site infections at 6 months post operatively in patients undergoing Trans abdominal pre peritoneal repair versus Lichtenstein open repair. Then assessment of outcomes is done.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • 1.Primary unilateral inguinal hernia 2.Direct or Indirect hernia 3.Adult patients (Age more than 18 years and less than 60 years).

排除标准

  • 1.Female gender 2.Age less than 18 Years and more than 60 Years 3.Recurrent inguinal hernia on same side 4.Concomitant another procedure of hernia 5.Bilateral inguinal hernia with repair on both sides.
  • 6.Patients not willing to be part of the study or assigned group.
  • 7.Hernias from other than inguinal region.
  • 8.Patients with previous lower Abdominal surgery or Trauma that may complicate laparoscopic access 9.Complicated hernia: Patients with obstructed, strangulated, or incarcerated hernias requiring emergency surgery 10.Patients with previous history of Diabetes Mellitus.
  • 11.Patients with severe cardio-pulmonary or systemic illness precluding general anaesthesia which is required for TAPP.
  • 12.Morbid Obesity (BMI greater than or equal to 35, which may hinder laparoscopic access or increase surgical risks.
  • 13.Anesthesia related post operative complications to be excluded.

结局指标

主要结局

1.Operative time.

时间窗: Operative time will be assessed intraoperatively | Duration of hospital stay will be assessed postoperatively on day 1 day 3 day 5 or further if prolonged stay. Time to return to normal activities will assessed on day 1 day 3 day 5 at the time when patient comes for suture removal or further if prolonged duration. Incidence of seroma or hematoma or surgical site infections during hospital stay will be assessed on day 1 day 3 and further if prolonged hospital stay

2.Duration of hospital stay.

时间窗: Operative time will be assessed intraoperatively | Duration of hospital stay will be assessed postoperatively on day 1 day 3 day 5 or further if prolonged stay. Time to return to normal activities will assessed on day 1 day 3 day 5 at the time when patient comes for suture removal or further if prolonged duration. Incidence of seroma or hematoma or surgical site infections during hospital stay will be assessed on day 1 day 3 and further if prolonged hospital stay

3.Time to return to normal activities or work.

时间窗: Operative time will be assessed intraoperatively | Duration of hospital stay will be assessed postoperatively on day 1 day 3 day 5 or further if prolonged stay. Time to return to normal activities will assessed on day 1 day 3 day 5 at the time when patient comes for suture removal or further if prolonged duration. Incidence of seroma or hematoma or surgical site infections during hospital stay will be assessed on day 1 day 3 and further if prolonged hospital stay

4.Incidence of seroma or hematoma or surgical site infections during hospital stay.

时间窗: Operative time will be assessed intraoperatively | Duration of hospital stay will be assessed postoperatively on day 1 day 3 day 5 or further if prolonged stay. Time to return to normal activities will assessed on day 1 day 3 day 5 at the time when patient comes for suture removal or further if prolonged duration. Incidence of seroma or hematoma or surgical site infections during hospital stay will be assessed on day 1 day 3 and further if prolonged hospital stay

次要结局

  • 1.To evaluate the incidence ,severity of chronic pain(2.To evaluate the incidence of surgical site infections)

研究者

发起方
Dr Budarapu Vishnu Vardhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Budarapu Vishnu Vardhan

All India Institute of Medical Sciences Gorakhpur

研究点 (1)

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