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A Randomized Trial Comparing Pain-related Outcomes Using Objective Pain Measurement Following Laparoscopic And Open Groin Hernia Repair

A Randomized Trial Comparing Pain Threshold Using Quantitative Sensory Testing In Patients With Primary Groin Hernia Following Laparoscopic Groin Hernia Repair And Lichtenstein Open Mesh Repair

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045456
Enrollment
64
Registered
2022-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 2: O- Medical and Surgical Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Laparoscopic groin hernia repair: Patients will be randomized to either Totally Extraperitoneal Repair or Transabdominal Preperitoneal Repair in the laparoscopic arm Control Interventio

Sponsors

Dr Jasmine Dhal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with uncomplicated primary groin hernia, fit to undergo either laparoscopic groin hernia repair or Lichtenstein open mesh repair

Exclusion criteria

Exclusion criteria: 1. Age 75 years 2. Complicated, i.e., strangulated or obstructed hernia 3. Recurrent inguinal hernia 4. History of previous pelvic or lower abdominal surgery 5. History of hernia repair either on same or contralateral ide 6. History of chronic systemic or mental illness 7. Diabetes mellitus and chronic kidney disease 8. Chronic analgesic/ opioid abuse 9. Unfit for general anesthesia 10. Coagulopathies

Design outcomes

Primary

MeasureTime frame
To compare the preoperative and postoperative pain threshold at 6 weeks and 3 months, via Quantitative Sensory Testing, using non-invasive thermal stimulus, between laparoscopic groin hernia repair and Lichtenstein open mesh repairTimepoint: Baseline, 6 weeks, 3 months—

Secondary

MeasureTime frame
To determine risk factors for early postoperative and chronic groin pain following laparoscopic groin hernia repair and Lichtenstein open mesh repairTimepoint: Not applicable;To study the correlation of pain threshold and pain scores with hernia-related quality of life, using Carolinas Comfort Scale and World Health Organization Quality Of Life Instrument (WHOQOL-BREF Questionnaire)Timepoint: Preoperatively, 6 weeks, 3 months;To study the correlation of pain threshold with postoperative pain scores at 12 hours, 24 hours, or at the time of discharge, 1 week, 6 weeks and 3 months, in terms of Visual Analogue Scale scoresTimepoint: 12 hours, 24 hours or at the time of discharge, 1 week, 6 weeks, 3 months—

Countries

India

Contacts

Public ContactDr Virinder Kumar Bansal

All India Institute of Medical Sciences, New Delhi

drvkbansal@gmail.com9810348479

Outcome results

None listed

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