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Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial.
Trials 2018; 19(1):322T

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.

Authors+Show Affiliations

Department of Surgery/Hernia Clinic, Diakonessenhuis, Utrecht/Zeist, The Netherlands. mroos@diakhuis.nl.Department of Surgery/Hernia Clinic, Diakonessenhuis, Utrecht/Zeist, The Netherlands.Department of Radiology, Diakonessenhuis, Utrecht/Zeist, The Netherlands.Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.Department of Surgery/Hernia Clinic, Diakonessenhuis, Utrecht/Zeist, The Netherlands.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29914545

Citation

Roos, Marleen M., et al. "Effectiveness of Endoscopic Totally Extraperitoneal (TEP) Hernia Correction for Clinically Occult Inguinal Hernia (EFFECT): Study Protocol for a Randomized Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 322.
Roos MM, Verleisdonk EMM, Sanders FBM, et al. Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial. Trials. 2018;19(1):322.
Roos, M. M., Verleisdonk, E. M. M., Sanders, F. B. M., Hoes, A. W., Stellato, R. K., Frederix, G. W. J., ... Burgmans, J. P. J. (2018). Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial. Trials, 19(1), p. 322. doi:10.1186/s13063-018-2711-7.
Roos MM, et al. Effectiveness of Endoscopic Totally Extraperitoneal (TEP) Hernia Correction for Clinically Occult Inguinal Hernia (EFFECT): Study Protocol for a Randomized Controlled Trial. Trials. 2018 Jun 18;19(1):322. PubMed PMID: 29914545.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial. AU - Roos,Marleen M, AU - Verleisdonk,Egbert-Jan M M, AU - Sanders,Floris B M, AU - Hoes,Arno W, AU - Stellato,Rebecca K, AU - Frederix,Geert W J, AU - Simmermacher,Rogier K J, AU - Burgmans,Josephina P J, AU - ,, Y1 - 2018/06/18/ PY - 2018/01/15/received PY - 2018/05/25/accepted PY - 2018/6/20/entrez PY - 2018/6/20/pubmed PY - 2019/3/15/medline KW - Clinically occult KW - Cost-effectiveness KW - Inguinal hernia KW - Pain KW - Quality of life KW - TEP KW - Watchful waiting SP - 322 EP - 322 JF - Trials JO - Trials VL - 19 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29914545/Effectiveness_of_endoscopic_totally_extraperitoneal__TEP__hernia_correction_for_clinically_occult_inguinal_hernia__EFFECT_:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2711-7 DB - PRIME DP - Unbound Medicine ER -