Patient-reported outcomes after robotic and conventional laparoscopic transabdominal preperitoneal inguinal hernia repair: the PROTAPP study
- Conditions
- K40Inguinal hernia
- Registration Number
- DRKS00031257
- Lead Sponsor
- Kantonsspital Baselland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Male and female patients with inguinal hernias scheduled for robotic TAPP or laparoscopic TAPP repair will be included. Patients have to be 18 years of age for study participation. There is no upper age limit. Patients with unilateral hernias and bilateral hernias will be included. Patients from all ethnic and sociodemographic backgrounds will be included, as long as they do not represent exclusion criteria as specified below.
Exclusion Criteria
Patients younger than 18 years. Vulnerable Patients (e.g. pregnant patients, emergencies, prisoners). Inability to follow procedures or insufficient knowledge of project language (German). Inability to give consent. No access to a personal smart phone device using Android or iOS.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - COMI Hernia total score 6 weeks after robotic TAPP.<br>- COMI Hernia total score 6 weeks after laparoscopic TAPP.<br>(COMI Hernia = Core Outcome Measure Index Hernia, a score determined by a questionnaire, which describes quality of life before and after inguinal hernia repair).
- Secondary Outcome Measures
Name Time Method - COMI Hernia total score 52 weeks after rTAPP.<br>- COMI Hernia subscores 6 and 52 weeks after rTAPP.<br>- Rates of complications and hernia recurrence 6 and 52 weeks after rTAPP.<br>- Patient satisfaction (5 point Likert scale) 6 and 52 weeks after rTAPP.<br>- COMI Hernia total score 52 weeks after LTAPP.<br>- COMI Hernia subscores after 6 and 52 weeks after LTAPP.<br>- Rates of complications and hernia recurrence 6 and 52 weeks after LTAPP.<br>- Patient satisfaction (5 point Likert scale) 6 and 52 weeks after LTAPP.<br>(COMI Hernia = Core Outcome Measure Index Hernia, a score determined by a questionnaire, which describes quality of life before and after inguinal hernia repair).