Patient-assessed outcome up to three months in a randomised controlled trial comparing laparoscopic with open groin hernia repair

Hernia ◽  
2000 ◽  
Vol 4 (2) ◽  
pp. 73-79 ◽  
Author(s):  
N. W. Scott ◽  
A. M. Grant ◽  
S. J. Ross ◽  
A. Smith ◽  
I. M. C. Macintyre ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hernia Repair ◽  
Groin Hernia ◽  
Controlled Trial ◽  
Groin Hernia Repair ◽  
Randomised Controlled

Preventive Analgesic Efficacy of Intravenous Tramadol Versus Intravenous Nalbuphine for Elective Inguinal Hernia Repair Surgeries :Randomised Controlled Trial

2017 ◽  
Vol 4 (3 (part-1)) ◽  
pp. 629-634
Author(s):  
Bhavani Vaidiyanathan ◽  
◽  
Deepak Paulose Thattayathu ◽  
Sangeeta Dhanger ◽  
Irudhaya Joseph Raajesh ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Randomised Controlled Trial ◽  
Hernia Repair ◽  
Inguinal Hernia Repair ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Randomised Controlled

scholarly journals Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kelly M. A. Dreuning ◽  
Maurits W. van Tulder ◽  
Jasper V. Been ◽  
Maroeska M. Rovers ◽  
Jurgen C. de Graaff ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hernia Repair ◽  
Controlled Trial ◽  
Surgical Exploration ◽  
Contralateral Exploration ◽  
Unilateral Inguinal Hernia ◽  
Randomised Controlled

Abstract Background The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5–30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely. Methods The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants’ health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed. Discussion This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia. Trial registration ClinicalTrials.govNCT03623893. Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018

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