Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial

Authors: Marleen M. Roos, Egbert-Jan M. M. Verleisdonk, Floris B. M. Sanders, Arno W. Hoes, Rebecca K. Stellato, Geert W. J. Frederix, Rogier K. J. Simmermacher, Josephina P. J. Burgmans, EFFECT study group

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain.
The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia.

Methods

The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year.

Discussion

This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved.

Trial registration

The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry (NTR6835) registered on November 13, 2017.
Appendix
Available only for authorised users
Literature
1.
2.
Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009;13(4):343–403.CrossRefPubMedPubMedCentral
3.
Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Simons MP. Update with level 1 studies of the European hernia society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2014;18(2):151–63.CrossRefPubMed
4.
Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European registry for Abdominal Wall hernias quality of life instrument. Surgery. 2016;160(5):1344–57.CrossRefPubMed
5.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRefPubMedPubMedCentral
6.
7.
Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA productivity cost questionnaire; a standardized instrument for measuring and valuing health-related productivity losses. Value Health. 2015;18(6):753–8.CrossRefPubMed
8.
Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numeric rating scale. Eur J Pain. 2004;8(4):283–91.CrossRefPubMed
9.
Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60(12):1234–8.CrossRefPubMed
10.
Calder F, Evans R, Neilson D, Hurley P. Value of herniography in the management of occult hernia and chronic pain in adults. Br J Surg. 2000;87(6):824–5.CrossRefPubMed
11.
Gamer JP, Patel S, Glaves J, Ravi K. Is herniography useful? Hernia. 2006;10:66–9.CrossRef
12.
Gwanmesia I, Walsh S, Bury R, Bowyer K, Walker S. Unexplained groin pain: safety and reliability of herniography for the diagnosis of occult hernias. Postgrad Med J. 2001;77:250–1.CrossRefPubMedPubMedCentral
13.
Hall C, Hall PN, Wingate JP, Neoptelemos JP. Evaluation of herniography in the diagnosis of an occult abdominal wall hernia in symptomatic adults. Br J Surg. 1990;77:902–6.CrossRefPubMed
14.
Heise CP, Sprout IA, Starling JR. Peritoneography (herniography) for detecting occult inguinal hernia in patients with inguinodynia. Ann Surg. 2002;235:140–4.CrossRefPubMedPubMedCentral
15.
Loftus IM, Ubhi SS, Rodgers PM, Watkin DF. A negative herniogram does not exclude the presence of a hernia. Ann R Coll Surg Engl. 1997;79(5):372–5.PubMedPubMedCentral
16.
Ekberg O. Complications after herniography in adults. Am J Roentgenol. 1983;140:490–5.CrossRef
17.
Alam A, Nice C, Uberoi R. The accuracy of ultrasound in the diagnosis of clinically occult groin hernias in adults. Eur Radiol. 2005;15:2457–61.CrossRefPubMed
18.
Lilly MC, Arregui ME. Ultrasound of the inguinal floor for evaluation of hernias. Surg Endosc. 2002;16:659–62.CrossRefPubMed
19.
Robinson P, Hensor E, Lansdown MJ, Ambrose NS, Chapman AH. Inguinofemoral hernia: accuracy of sonography in patients with indeterminate clinical features. AJR Am J Roentgenol. 2006;187:1168–78.CrossRefPubMed
20.
van den Berg JC, de Valois JC, Go PM, Rosenbusch G. Detection of groin hernia with physical examination, ultrasound and MRI compared with laparoscopic findings. Investig Radiol. 1999;34:739–43.CrossRef
21.
Robinson A, Light D, Kasim A, Nice C. A systematic review and meta-analysis of the role of radiology in the diagnosis of occult inguinal hernia. Surg Endosc. 2013;27:11–8.CrossRefPubMed
22.
Miller J, Cho J, Michael MJ, Saouaf R, Towfigh S. Role of imaging in the diagnosis of occult hernias. JAMA Surg. 2014;149(10):1077–80.CrossRefPubMed
Metadata
Title
Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial
Authors
Marleen M. Roos
Egbert-Jan M. M. Verleisdonk
Floris B. M. Sanders
Arno W. Hoes
Rebecca K. Stellato
Geert W. J. Frederix
Rogier K. J. Simmermacher
Josephina P. J. Burgmans
EFFECT study group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2711-7

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Research on the mechanism of drug–drug interaction between salvianolate injection and aspirin based on the metabolic enzyme and PK-PD model: study protocol for a PK-PD trial

Study protocol

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial

Research

Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review

Study protocol

Physical Activity after Cardiac EventS (PACES) – a group education programme with subsequent text-message support designed to increase physical activity in individuals with diagnosed coronary heart disease: study protocol for a randomised controlled trial

Study protocol

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty

Research

Speech-guided breathing retraining in asthma: a randomised controlled crossover trial in real-life outpatient settings