跳至主要内容
临床试验/CTRI/2023/09/057520
CTRI/2023/09/057520尚未招募Phase 3 4

A randomised control study to compare Extended view Totally Extraperitoneal Repair (eTEP) vs Trans Abdominal Pre-Peritoneal Repair (TAPP) in terms of early post-operative complications in groin hernias

ABVIMS, Dr. RML hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
seroma

研究概览

简要总结

Groin hernia is one of the commonest problemsencountered in general surgery practice.

Surgical procedure is the mainstay of management ofgroin hernia. Groin hernias can be repaired by either open or laparoscopictechniques. With advancements in endoscopic technology, laparoscopic herniasurgery is being increasingly used.

Earlier, open hernia repair used to be the most commonform of hernia repair. However, recently minimally invasive surgery has becomea more popular procedure for surgeons. It utilizes posterior approach forrepair of hernias in contrast to the anterior approach seen in open herniarepair.

Understanding the anatomy of the posterior approach isimperative in performing a successful dissection. Considering this, Daes andFelix introduced the concept of critical view of Myopectineal Orifice. Theanatomy of myopectineal orifice is defined as follows; it is bounded mediallyby the rectus abdominis muscle, laterally by the psoas, inferiorly by thepectineus ligament and superiorly by transversus abdominis muscle along withinternal oblique muscle.

The Extended view total extraperitoneal approach(eTEP) offers the advantage of reduced risk of intestinal and vascular injuriesas the peritoneum is not breached and  abdominal cavity is not entered. It allows foreasy and fast creation of extraperitoneal space along with a wider surgicalfield and improved tolerance for pneumoperitoneum. It also allows for the laparoscopicrepair in cases of obese patients, short umbilicus to pubic tubercle distanceand in previous pelvic surgeries.

Transabdominal pre-peritoneal hernia repair (TAPP)offers the advantage of having a shorter learning curve, being able to diagnoseoccult hernias and in the repair of incarcerated or strangulated hernias.

This study aims at comparing Extended view Totallyextra-peritoneal repair (eTEP) and Trans abdominal pre peritoneal repair (TAPP)and whether these are comparable in terms of early post-operative complicationsas no such study on eTEP and TAPP has been published.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Consecutive Adult patients with primary inguinal hernia.

排除标准

  • Previous lower abdominal surgeries Recurrent hernia Obstructed or strangulated hernia Associated hydrocele, epididymitis H/O orchidectomy ASA 3 or more.

结局指标

主要结局

seroma

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

pain

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Early post-operative complications

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

scrotal hematoma

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

次要结局

  • Intra-op complications(Operative Time)

研究者

发起方
ABVIMS, Dr. RML hospital
申办方类型
Government medical college

研究点 (1)

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