Health TrialsbyHealthPanel

Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

ConditionInguinal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients presenting with a bilateral inguinal hernia planned for a minimal invasive laparoscopic repair

Disqualifiers

Age below 18 years

unilateral groin hernia repair

incarcerated hernias

open hernia repair

Trial design

Design model

Parallel

Treatments tested in this trial

  • r-TAPP

    Procedure/Surgery

    Robot-assisted repair

  • l-TAPP

    Procedure/Surgery

    Laporoscopic repair

  • local anesthetics

    Procedure/Surgery

    local anesthetics will be administred

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: l-TAPP without local anestheticsOther 1 intervention
Group B: l-TAPP with local anestheticsOther 2 interventions
Group C: r-TAPP without local anestheticsOther 1 intervention
Group D: r-TAPP with local anestheticsOther 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
change of Baseline PADSS score up to 24h after surgery or unitl score is ≥ 9

Secondary outcomes

1

Recurrence rate

Recurrence rate will be assessed at 12 months post-operatively

Time frame
at 12 month
2

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.

Time frame
1 month and 12 months post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Algemeen Ziekenhuis Maria Middelares

Lead sponsor

Source ClinicalTrials.gov
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