Pain and Quality of Life After Inguinal Hernia Repair. Randomized Study Comparing Laparoscopic TAPP Repair With Open Lichtenstein Repair (QoL-TAPP Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Chronic pain
Study Overview
Brief Summary
This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia. Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score).
Detailed Description
Inguinal hernia repair is one of the most frequently performed surgical operations. Since the introduction of mesh repair, recurrence rates have fallen dramatically and chronic pain, as a side-effect of surgery, is becoming increasingly important.
Chronic pain is defined as pain or discomfort that lasts for more than 3 months after surgery. The reported incidence of chronic pain varies between 0 and 75 per cent after open mesh repair, and between 0 and 29 per cent after laparoscopic repair. Prospective trials suggest that there is less chronic pain after laparoscopic than open repair.
Although pain is an important parameter determining the Quality of Life (QoL) after a hernia operation, other aspects, like restriction of activities and esthetical outcome, are also of importance.
This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia.
Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score). The EuraHS-QoL score is a validated hernia specific questionnaire with 9 questions that can be scored by the patient in an 11-point scale from 0-10. The EuraHS-QoL questions are divided in 3 domains: "Pain" (range 0-30), "Restriction of activities" (range 0-40), and "Esthetical discomfort" (range 0-20). The total score ranges from 0-90, with the lower scores being the most favourable outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary inguinal hernia
- •unilateral hernia
Exclusion Criteria
- •bilateral hernia
- •recurrent hernia
- •incarcerated hernia
- •large scrotal hernia
- •known femoral hernia
- •need for associated procedures
- •not able to understand the questionaire
- •immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- •chronic renal failure (hemodialysis)
- •active infection
- •pregnancy
- •allergy to polypropylene or cyanoacrylate
- •patient's refusal and/or absence of informed consent
Arms & Interventions
Laparoscopic repair
Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)
Intervention: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair) (Procedure)
Open repair
Open Inguinal Hernia Repair (Lichtenstein repair)
Intervention: Open Inguinal Hernia Repair (Lichtenstein repair) (Procedure)
Outcomes
Primary Outcomes
Chronic pain
Time Frame: 1 year
Pain scores (0-10) using the European Registry for Abdominal Wall Hernias Quality of Life Instrument (EuraHS Quality of Life questionnaire). Each question has a scale from 0-10, whereas 0 is considered the best outcome.
Secondary Outcomes
- Duration of surgery(Surgery)
- Rate of postoperative complications(30 days)
- Restrictions of activities(1 year)
- Early recurrences(1-year)
- Cosmetic discomfort(1 year)