Inguinal Hernia Clinical Trial
Official title:
Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult patients presenting with a bilateral inguinal hernia planned for a minimal invasive laparoscopic repair Exclusion Criteria: - Age below 18 years - unilateral groin hernia repair - incarcerated hernias - open hernia repair - no informed consent - pregnant women - ASA score 4 or more - patient included in another study. |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Maria Middelares | Ghent |
Lead Sponsor | Collaborator |
---|---|
Algemeen Ziekenhuis Maria Middelares |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in PADSS score | Time postoperative for the patient to get fit for discharge as determined by a PADSS score (Post Anesthesia Discharge Scoring System) to reach = 9 (10 is maximum). The score will be taken at 2 hourly intervals after surgery (0 hours,2 hours,4 hours,6 hours,8 hours,10 hours,12 hours,14 hours,16 hours,18 hours,20 hours,22 hours,24 hours) up to 24 hours or unitl score is = 9. | change of Baseline PADSS score up to 24h after surgery or unitl score is = 9 | |
Secondary | Recurrence rate | Recurrence rate will be assessed at 12 months post-operatively | at 12 month | |
Secondary | Quality of Life assessment: EuraHS Quality of Life questionnaire | Quality of Life assessment using the EuraHS Quality of Life questionnaire. The questionnaire consists of 9 questions. Each question has a scale from 0-10, wherease 0 is considered the best outcome. Total score (max.90) is assessed by summerizing the scale of each question. | 1 month and 12 months post-operatively |
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