Comparison of one layer vs. two layer Modified Kugel mesh for inguinal herniorrhaphy

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participating are randomised on a 1:1 basis. Participants are randomly allocated based on a numbering system to being in group one or group two. Surgery is scheduled for one week after clinical visit. All fees incurred are paid by the National Health Care Insurance or patients' own insurance Group one: Participants undergo the open hernia repair surgical procedure to repair the hernia and then they receive the single layer pre‐peritoneal Modified Kugel (MK) mesh placement in the per‐peritoneal space. This is done through a 3‐4 cm inguinal incision. Group two: Participants receive the same procedure as Group one patients but also receive the additional on‐lay in the inguinal canal. This is also done through a 3‐4 cm inguinal incision. The surgical approach in each group is feasible and there is no standard of treatment, however those in group one will act as a control in order to compare their outcomes with those in group two to see if an optional on‐lay has any benefits than the one layer mesh. After the surgery, a separate research personnel (not the surgeon whom performed the surgery) follows‐up all the patients for at least one year after surgery at set intervals (seven days, one, three, six and 12 months) with a set of questionnaires. The data is the passed to another research personnel for data analysis. CONDITION: Inguinal hernia repair using open method ; Digestive System ; Inguinal hernia repair using open method PRIMARY OUTCOME: 1. Recurrence is measured using a clinical visit at day seven and through questionnaires via telephone interviews at one, three, six and 12 months ; 2. Pain is measured using a clinical visit at post‐OP day seven and through questionnaires via telephone interviews at one, three, six and 12 months ; 3. Inguinal nerve neuropathy is measured using a clinical visit at day seven and through questionnaires via telephone interviews at one, three, six and 12 months SECONDARY OUTCOME: Foreign body sensation are measured using a clinical visit at day seven and through questionnaires via telephone interviews at one, three, six and 12 months. INCLUSION CRITERIA: 1. Any patient undergoing elective inguinal herniorrhaphy at Changhua Christian Hospital 2. All ages and genders 3. Any patient with clinical presentation of inguinal hernia is eligible for our study
Epistemonikos ID: 14636cead031c85b1499e2067ba344586ccf6efc
First added on: Aug 23, 2024