Prosthetic material (Mesh) anchored by mechanical device versus glue during laparoscopic repair of abdominal wall hernia: A double blind randomised control trial

Mesh fixation with penetrating fixation device versus fibrin sealant during laparoscopic repair of ventral hernia: A double blind randomised control trial double blind randomised control trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011268

Enrollment

Registered

2018-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Primary ventral hernia

Interventions

Intervention1: Laparoscopic repair of ventral hernia: During laparoscopic repair of ventral hernia a mesh is placed at the hernia site. This mesh needs to be fixed to the abdominal wall. Mesh can be f

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients (adult male and females > 18 and <65 years old) admitted for elective laparoscopic repair of primary ventral hernia.

Exclusion criteria

Exclusion criteria: 1. Defect size less than 1 cm and greater than 5 cm on pre-operative ultrasound. 2. Secondary hernias including insicional hernia or parastomal hernia 3. Non midline ventral hernia 4. Patients with ASA grade IV and V 5. Significant co-morbidities like coronary artery disease, asthma, COPD, and previous malignancy. 6. Patients requiring other concomitant procedures. 7. Patients who do not give consent for participation in the study or patient with cognitive impairments 8. Patients on chronic analgesic use 9. Patients with uncorrectable coagulopathy

Design outcomes

Primary

Measure	Time frame
Abdominal pain evaluated on Visual Analogue Scale (VAS) ranging from 0(no pain) to 10(worst pain ever) at rest and during movementTimepoint: Pain will be measure at 6, 12, 24 hours and 7 days 30 days,3 month and 1 yearafter Laparoscopic ventral hernia repair both at rest and at movement	—

Secondary

Measure	Time frame
1. Duration of surgeryTimepoint: 1;2. Seroma formationTimepoint: 7 days, 1 month and at 3 months post operatively;3. Quality of lifeTimepoint: Pre operatively and at one month, three months and one year following surgery;4. Patient satisfaction scoreTimepoint: At one month, three months and one year following surgery;5. RecurrenceTimepoint: At three months and one year;6. Cost analysisTimepoint: 1	—

Measure

Time frame

1. Duration of surgeryTimepoint: 1;2. Seroma formationTimepoint: 7 days, 1 month and at 3 months post operatively;3. Quality of lifeTimepoint: Pre operatively and at one month, three months and one year following surgery;4. Patient satisfaction scoreTimepoint: At one month, three months and one year following surgery;5. RecurrenceTimepoint: At three months and one year;6. Cost analysisTimepoint: 1

—

Countries

India

Contacts

Public ContactDr Mithun K

Department of Surgical Disciplines, AIIMS, New Delhi

dr_hkb75@yahoo.com7838621462

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026