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Clinical Trials/CTRI/2023/09/057520
CTRI/2023/09/057520Not yet recruitingPhase 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 site in 1 country70 target enrollmentStarted: July 12, 2023Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
seroma

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Consecutive Adult patients with primary inguinal hernia.

Exclusion Criteria

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

Outcomes

Primary Outcomes

seroma

Time Frame: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

pain

Time Frame: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Early post-operative complications

Time Frame: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

scrotal hematoma

Time Frame: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Secondary Outcomes

  • Intra-op complications(Operative Time)

Investigators

Sponsor
ABVIMS, Dr. RML hospital
Sponsor Class
Government medical college

Study Sites (1)

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