| The primary objective of this multicentre study is to investigate whether abstaining from operation is a better alternative to surgical treatment in male inguinal hernia patients. The target sample of 800 men will be randomly assigned to either surgical or observational non-surgical management. The outcomes of the study are pain/discomfort, quality of life, event-free survival and costs. An inguinal hernia or a groin hernia, is a protrusion (lump) of the small intestine or fatty tissue into the groin through a weakness or tear in the abdominal wall and the peritoneum. In the Netherlands, 30651 inguinal hernias were corrected in the year 2002, making it one of the most frequently performed operations in surgery. Of these hernias 89% was corrected in male patients. Up to 61% of all these male inguinal hernia patients is over 50 years of age [1]. The number of incarcerations/strangulations can only be investigated in the group that is managed observationally. In the group that is treated surgically incarcerations/ strangulations will not occur. A special Data Safety and Monitoring Committee (as mentioned below) will monitor adverse events, including serious adverse events, such as incarceration/strangulation. The primary objective of this study is to investigate whether watchful waiting is a better alternative to hernia operation in minimally symptomatic or asymptomatic male inguinal hernia patients over 50 years of age with respect to pain and discomfort. This research question will be answered by testing the following hypothesis: With a sample size of 800 patients (for calculation sample size, see page 12) observational management of 400 inguinal hernia patients will save one patient's life. As a result of the ten times higher mortality associated with elective hernia repair, one patient will die in 400 patients treated surgically (0,002x400=0,80) while no patients will die from surgery in case of observational management of 400 inguinal hernia (0,0002x400=0,08). Thus it may be that surgical treatment of a hernia is not a good option and a non-surgical observational approach should be the routine. Additionally, the percentage of patients with chronic pain after inguinal hernia repair is very high[8]. Therefore a trial is needed to compare the outcomes of surgical and observational management of inguinal hernia in men to provide data to surgeons, general practitioners and patients that can aid in choice of treatment. A Steering Committee including the principal investigators, the local investigators and other key people who take responsibility for the scientific integrity of the study, will meet prior to recruitment for the study to agree on the final protocol. Subsequently they will contact each other at regular intervals during the study to monitor progress and meet finally at the end of the study to review the results. The design of the trial is a multicentre, open, randomised controlled trial. Inguinal hernia patients matching the following inclusion criteria are asked to take part in the study. |
