|- candidate number||28187|
|- NTR Number||NTR6835|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2017|
|- Secondary IDs||NL61730.100.17 / 843004118 METC / ZonMw|
|- Public Title||Effectiveness of total extraperitoneal hernia correction for clinically occult inguinal hernia: a multicenter randomized controlled trial|
|- Scientific Title||Effectiveness of total extraperitoneal hernia correction for clinically occult inguinal hernia: a multicenter randomized controlled trial|
|- ACRONYM||EFFECT trial|
|- hypothesis||A watchful waiting approach is non-inferior to application of the endoscopic totally extraperitoneal (TEP) inguinal hernia correction in terms of pain reduction and quality of life 3 months after treatment|
|- Healt Condition(s) or Problem(s) studied||Inguinal hernia, Pain, Cost-effectiveness , Quality of life, Clinically occult|
|- Inclusion criteria||- Age 18 years or older |
- Unilateral groin pain (minimum NRS score of 1 during rest and/or physical activity)
- No features of an inguinal hernia on physical examination
- Radiologic diagnosis of an inguinal hernia on ultrasonography
|- Exclusion criteria||- Previous inguinal hernia on the symptomatic side|
- Previous surgery in inguinal region of the symptomatic side
- BMI > 40
- ASA classification > III
- Reasons that complicate follow-up by means of questionnaires (eg. language barrier, psychiatric disorders)
- Unwilling to undergo surgery
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-dec-2017|
|- planned closingdate||29-jun-2021|
|- Target number of participants||160|
|- Interventions||- Endoscopic totally extraperitoneal (TEP) inguinal hernia correction|
- Watchful waiting approach (treatment will consist of rest, painkillers and optional physiotherapy)
|- Primary outcome||Reduction in pain intensity, measured in rest and during physical activity by the numeric rating scale (NRS)|
|- Secondary outcome||- Pain intensity 1.5,6 and 12 months after treatment|
- Quality of life
- Health care use
- Duration to resumption of daily and professional activities
- Morbidity after treatment
- Cross-over rate
- Patient satisfaction
|- Timepoints||Baseline, 1.5 months after treatment, 3 months after treatment, 6 months after treatment, 12 months after treatment|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Coen Hessen, van|
|- CONTACT for SCIENTIFIC QUERIES|| Ine Burgmans|
|- Sponsor/Initiator ||Diakonessenhuis Utrecht, The Netherlands., Diakonessenhuis Zeist|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective|
To evaluate the (cost-)effectiveness of endoscopic totally extraperitoneal (TEP) inguinal hernia correction compared to watchful waiting in patients with groin pain and a clinically occult inguinal hernia.
A watchful waiting approach is non-inferior to application of the endoscopic totally extraperitoneal (TEP) inguinal hernia correction in terms of pain reduction and quality of life 3 months after treatment.
The study design is a multicenter non-blinded randomized controlled non-inferiority trial.
The study population will consist of patients with groin pain and a clinically occult inguinal hernia; no features of an inguinal hernia can be detected on physical examination, while ultrasonography shows an inguinal hernia on the symptomatic side.
The intervention to be evaluated in this study is the endoscopic total extraperitoneal (TEP) inguinal hernia correction.
Outcomes of TEP inguinal hernia repair will be compared to a watchful waiting approach. Treatment will consist of rest, painkillers and optional physiotherapy.
The primary outcome measure of this study will be the reduction in pain intensity, measured in rest and during physical activity by the Numeric Rating Scale (NRS), 3 months after treatment.Secondary outcome measures are: Pain intensity 1.5,6 and 12 months after treatment, quality of life, health care use, duration to resumption of daily and professional activities, patient satisfaction and cost effectiveness.
Based on the assumption that both treatments will be similar in terms of pain reduction 3 months after treatment, a sample size that could detect the smallest clinically relevant difference between the two treatment modalities was calculated. Using an equivalence margin of a NRS of 0.75, the total sample size should be at least 160 patients, with 80 patients per arm.
The study duration will be 42 months. The first period up to a maximum of 30 months will consist of inclusion and follow-up, in the period hereafter follow-up, data analysis and reporting of the results will be performed.
|- Main changes (audit trail)|
|- RECORD||13-nov-2017 - 10-dec-2017|