Open mesh groin hernia repair in women - a comparison of two surgical methods

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: All patients will be physically examined, including ultrasonography of the groin, for diagnosis. All patients will be operated for their groin hernia. Two techniques will be used. The duration of the surgery will be 1‐2 hours in most cases, depending on the level of complexity. All patients will be followed up after 2 weeks, 1 year and 3 years. Patients will be randomised to the control or experimental group after diagnosis has been assured. A computer‐based program will be used and the randomisation will be done by a nurse. If a patient randomised to the control arm is found to have a femoral hernia (intraoperatively) she will cross over to the experimental arm). Control arm: Anterior mesh repair according to Lichtenstein, under local anaesthesia. Experimental arm: Modified anterior mesh repair under local anaesthesia. All steps are the same as for the control arm but in addition, the transversals fascia is opened and a slit of the mesh is fixed to cover the femoral canal. CONDITION: Groin hernia ; Digestive System ; Inguinal hernia and femoral hernia PRIMARY OUTCOME: Recurrence will be determined by a blinded observer through physical examination at 1 and 3 years. In unclear cases, ultrasonography will be used in addition to the physical examination. SECONDARY OUTCOME: ; 1. Postoperative complications will be determined through physical examination by a blinded observer at 2 weeks.; 2. Self‐Assessed health status will be measured using a health thermometer where 0 represents the worst imaginable health, and 100 represents the best imaginable health. This is done preoperatively, at 2 weeks, 1 year and 3 years.; 3. Patient satisfaction will be measured through asking the study participants "are you satisfied with the result of the operation?" as well as "are your level of groin symptoms less, the same or worse compared to before the surgery?". This is done at 1 and 3 years.; 4. Cost and cost‐effectiveness of the interventions will be calculated in terms of cost in USD per DALY averted. The IPQ results will be translated into disability weights for DALY calculation. Costs will be assessed from the providers perspective, including information on materials and medicines, staff costs, capital costs and overhead costs.; 5. Chronic pain will be measured using the Inguinal Pain Questionnaire. Level of pain will be assessed before the operation, and at 1 and 3 years postoperatively; INCLUSION CRITERIA: 1. Female 2. Primary, reducible groin hernia 3. ASA class 1‐2
Epistemonikos ID: 70282f6be1e81da612aab59da786959013d01705
First added on: Aug 24, 2024