Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia

Hernia, a common human disease, is defined as any organ or tissue leaving its normal location via congenital or acquired weak point, defect or fissure. Hernia frequently develops in inguinal (inguinal hernia), femoral (femoral hernia), umbilical (umbilical hernia), incision (incisional hernia) or diaphragmatic areas (diaphragmatic hernia).

Inguinal hernia accounts for more than 90% of all hernia. It is estimated 27% male and 3% female would be bothered by the inguinal hernia throughout the life. There were about 30 thousands of surgeries for hernia in Taiwan, and about 20 millions of surgeries for hernia worldwide annually. Inguinal hernia is classified into direct and indirect type. When testes passed through the inguinal canals into the scrotum before or after birth, the internal ring of inguinal canal would close gradually. Indirect type of inguinal hernia is abdominal organs or tissues enter the inguinal canal due to non-obliteration of internal ring. When inguinal hernia develops, one protruding mass would be seen on the groin area, and the patient feel pain and swelling. If the hernia could not be reduced spontaneously, the organ/tissue in the hernia sac would undergo blood supply disturbance, and organ/tissue necrosis, bowel perforation, even death follows. Surgery is usually suggested if one patient is diagnosed with inguinal hernia.

Open herniorrhaphy, which ligating the internal ring in the pre-peritoneal layer and then removing the hernia sac, is used to manage the indirect type of inguinal hernia traditionally. Incidence of inguinal hernia in children is about 5-6%, and almost is indirect type. Most patients are newborn to 6 years old. In 2006, Dr. Patkowski published percutaneous internal ring suture (PIRS) under laparoscopy. In PIRS the inner ring opening is closed by suture line in the pre-peritoneal layer under single-port laparoscopy. The hernia sac is remained without removal. It differs from the open herniorrhaphy is that the knots will tie the peritoneal layer and musculo-fascial layer at the same time, and patients were more painful after surgery. After 20-year observations, there was little difference found in the operation time and hernia recurrence rate between the open herniorrhaphy and PIRS. Surgical scars were smaller after PIRS, and it made PIRS being the routine surgery for indirect inguinal hernia in several children's hospitals in the America and Europe. In our hospital, there were more than 300 children with indirect inguinal hernia underwent single port laparoscopic PIRS since 2016. The operation time was less than 20 minutes in average. These children did not need admission, their recovery time was shorter, and the hernia recurrence rate was zero.

In adults, their inguinal hernia could be indirect, direct even mixed types. Inguinal hernia typing in adults often is not confirmed actually before surgery, yet the problem could be resolved during laparoscopy. Traditionally the main surgical method was to repair the inguinal hernia with mesh in the Hesselbach's triangle regardless of hernia type. The method could not satisfy every patient's requirement, and the overall hernia recurrence rate is 30-50%. In fact, 67-82% of adult cases with inguinal hernia belonged to the indirect type according to the published researches. Therefore, we thought single port laparoscopic PIRS could be utilized in adults also. In past 6 years, more than 100 adults underwent single port laparoscopic PIRS at our hospital for their indirect inguinal hernia. Hernia recurrence and chronic pain rate were 5%.

There is one new inguinal ring repair needle set developed recently, and which is suitable for single-port laparoscopic hernia surgery. The needle set is composed of puncture needle and suture guide needle. The puncture needle is composed of outer and inner sheath, and it can easily puncture and peel off the tissue. When the puncture needle arrives the inner ring of inguinal canal, removing the inner sheath, and outer sheath is left in the musculo-fascial layer. The suture guide needle is inserted into the outer sheath to tie and close the inner ring. The knot will naturally penetrate the muscular layer and stay on the peritoneal layer. In general, this hernia needle set can solve the inconvenience during the surgery and post-operative pain of patients.

This is a single-blind and randomized study to evaluate the safety and efficacy of the new inguinal needle set in managing the adults' indirect inguinal hernia.

• Trial period: Two years.
• Grouping: Divided into control and study group (sample size: 48 cases more than 18 years old in each group)
• Random sampling: participants will be randomized equally to receive ready-made or new needle set for inguinal hernia.
• Control group: Patients with indirect inguinal hernia and undergoing laparoscopic percutaneous internal ring suture via ready-made needle set.
• Trial period: 2025-05-01 to 2027-04-30.
• Follow-up period after surgery: six months.
• Test execution location: Chang Gung Memorial Hospital at Chiayi, Taiwan.
• Belonged to single center trial.
• Confidentiality of subject information: If the medical records would be used for reports and analysis, the subjects will be identified with codes and personal informations will be removed.
• Medical records would be used: (1) basic data: age, body height, body weight, BMI, hernia side, obliteration of the contralateral processus vaginalis, operation time, hospitalization days; (2) out-patient department follow up: post-operational pain severity and duration evaluated by Mankoski Pain Scale, analgesics kinds and frequencies, days for wound recovery, days for recovery of daily activities evaluated by Mankoski Pain Scale , hernia recurrence at the operational side.
• The primary endpoint: post-operational pain score