跳至主要内容
临床试验/CTRI/2025/02/080189
CTRI/2025/02/080189尚未招募4 期

To analyse the effect of laparoscopic defect closure in direct inguinal hernia repairs (Total Extra-Peritoneal and Trans-Abdominal Pre-Peritoneal Plus repairs) on post operative outcomes

Abirami J Raghunath1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月21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
50
试验地点
1
主要终点
Seroma formation assessed clinically and using USG when required

研究概览

简要总结

Following totally extraperitoneal (TOTAL EXTRA-PERITONEAL REPAIRS) and transabdominal preperitoneal (TRANS ABDOMINAL PRE-PERITONEAL PLUS REPAIRS) repair, complications such as seroma formation, hernia recurrence, and postoperative pain have continued to present challenges to surgeons. Studies have demonstrated lower post-operative pain and shorter time to recovery associated with laparoscopic inguinal hernia repair when compared to open surgery. However, some studies have also described higher rates of seroma formation (up to 12%) and recurrence (up to 5%) with laparoscopic inguinal hernia repair, which      can result in decreased quality of life. In 2019, a study done in Singapore posited a modified laparoscopic technique involving primary closure of the direct hernia defect prior to mesh insertion in patients with direct inguinal hernia. They demonstrated a statistically significant reduction in recurrence and seroma formation, especially in certain at-risk patient populations, and proposed to name this procedure the “TOTAL EXTRA-PERITONEAL AND TRANS ABDOMINAL PRE-PERITONEAL PLUS” technique. Direct defect closure has proven to be effective in reducing recurrence and seroma formation post-operatively in patients undergoing laparoscopic inguinal hernia repair. The study stated that randomized controlled trials are required to further evaluate these outcomes. This is a prospective interventional parallel arm randomised controlled trial to be conducted at Sri Ramachandra Institute of Higher Education and Research. After obtaining consent, the patients will be assigned to case (closure of defect) and control (non-closure of defect) groups, using coin toss method. Closure of defect will be standardised with 2-0 VLOC barbed absorbable monofilament suture, and  psuedosac will be incorporated during defect closure. Incidence of postoperative complications namely post-operative pain, seroma formation and recurrence of hernia will be compared, with serial follow-up at 1 week, 1 month, and 3 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective total extra-peritoneal and trans abdominal pre-peritoneal repairs for direct inguinal hernias.

排除标准

  • Patients undergoing emergency repair of hernia Patients undergoing open repair Patients undergoing hernia repair as part of another study Patients with pre-existing infections or chronic infectious diseases such as tuberculosis Patients not willing to participate in the study Patients not willing for surgery.

结局指标

主要结局

Seroma formation assessed clinically and using USG when required

时间窗: Seroma formation upto 10 days post op | Recurrence of inguinal hernia upto 3 months post op | Post operative pain upto 3 months post op

Recurrence of inguinal hernia assessed clinically

时间窗: Seroma formation upto 10 days post op | Recurrence of inguinal hernia upto 3 months post op | Post operative pain upto 3 months post op

Post operative pain assessed using visual analog scale

时间窗: Seroma formation upto 10 days post op | Recurrence of inguinal hernia upto 3 months post op | Post operative pain upto 3 months post op

次要结局

  • 1.Operative time in minutes(2.Hernia defect size & EHS classification)

研究者

发起方
Abirami J Raghunath
申办方类型
Other [primary]
责任方
Principal Investigator
主要研究者

ABIRAMI J RAGHUNATH

Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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