RANDOMISED CONTROLLED STUDY TO COMPARE INTRAPERITONEAL ONLAY MESH PLUS REPAIR VERSUS TRANSABDOMINAL PRE PERITONEAL MESH PLUS REPAIR FOR PATIENT WITH VENTRAL HERNIA

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,

• Registration Number: CTRI/2022/04/041759
• Lead Sponsor: ESIC Medical College and Hospital Faridabad

Brief Summary

Ventral hernia is the leading cause of abdominal pain, functional impairment and subacute intestinal obstruction. Large comparative studies have shown the advantage of laparoscopic repair over open repair. Conventional laparoscopic repair as popularised by Blanc and Booth in 1993 involves intraperitoneal placement of mesh. Limitation of which includes the requirement of costly composite mesh and fixating device. Also in few cases intraperitoneal mesh may lead to intestinal obstruction and perforation. The current trend among hernia surgeons is to place the mesh extraperitoneally or pre-peritoneally to avoid all the mesh related complications. The only limitation of pre-peritoneal mesh placement is slightly longer operative time and requirement of advanced laparoscopic skills. However there is paucity of literature comparing IPOM with TAPP which is limited to only few retrospective studies. Hence we are planning to conduct this prospective randomised  controlled study to know the advantages of one over another.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age ≥ 18 years Ventral hernia (Primary or Incisional) Defect size 2-8 cm.

Exclusion Criteria

• Patients undergoing emergency surgery 2.
• Parastomal or recurrent hernias 3.
• Unfit for General anesthesia and Laparoscopy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare postoperative morbidity including the pain scores and seroma rate	6hr, 24hr, 72 hr and than at 7, 30, 90, 180 and 360 days

Secondary Outcome Measures

Name	Time	Method
To compare length of hospital stay, surgical site infection (SSI), hernia recurrence, mesh infection, cost, operative time and patient quality of life

Trial Locations

Locations (1)

ESIC Medical College and Hospital; 🇮🇳 Faridabad, HARYANA, India

ESIC Medical College and Hospital

🇮🇳Faridabad, HARYANA, India

Dr Devender Singh

Principal investigator

09813643337

devinderkuntal@gmail.com