Clinical Research Directory

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

This is a prospective, single-blinded and randomized clinical trial, and will be conducted at Chang Gung Memorial Hospital Chiayi branch in Taiwan. 1. Why is this study being done? Inguinal hernia is a common condition in adults. It can be classified into different types, and more than half of adult inguinal hernias are belonged to the "indirect" type. Traditionally, inguinal hernias are repaired with artificial mesh in adults. Since 2018, we use the laparoscopy-assisted percutaneous internal ring suture (PIRS), which has been proofed to be safe and effectiveness in repairing the pediatric indirect inguinal hernia, to treat the adult indirect inguinal hernias. More than 150 adult patients were treated by using this method with good results and low recurrence rate. However, conventional needles for the pediatric group are too short and weak to operate on the adult group. Now there is a new device, laparoscopic non-mesh hernia needle set, designed specifically for adults. We would like to evaluate whether this new device can: (1) Shorten the operation time; (2) Reduce postoperative pain; (3) Maintain a low recurrence rate 2. What will happen to the participants The participants, whose hernia confirmed to be the indirect type under laparoscopic inspection, would be randomly assigned to one of two groups: (1) The control group: using conventional needle set for PIRS; (2) The experimental group: using laparoscopic non-mesh hernia needle set for PIRS. Both groups would undergo the same surgical method except the needle devices. For the participants with inguinal hernias other than the indirect type, an adequate mesh repair be performed according to the Guideline of Hernia Surg (Hernia. 2018; 22(1): 17-18) After surgery, three follow-up visits within six months would be arranged to all participants. Each visit will take about one hour. During these visits, we will: (1) Record about recovery and pain conditions; (2) Check surgical wound; (3) Evaluate whether the hernia has recurred. 3\. What are the possible complications? The risks of surgery are similar whether the participants join the study or not. Possible complications include: (1) Postoperative pain; (2) Hernia recurrence; (3) Wound infection; (4) Bruising or bleeding under the skin at the needle site This study will help us to determine whether the new needle set could decrease the complication rate. 4\. Participation in this study is completely voluntary. For the patients unwilling to participate this study, they will receive the standard procedures at present, including: (1) Open hernia repair with mesh, Lichtenstein method. (2) Laparoscopic hernia repair with mesh, TEP or TAPP. (3) Laparoscopic repair using the conventional hernia needle

Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males

This is a prospective, single-center, two-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias. Participants will be randomized to receive Fulvestrant 250 mg intramuscularly or anastrozole 1 mg orally for 6 months. The study will evaluate safety, tolerability, feasibility, hormone changes, hernia size, patient-reported outcomes, bone density, and imaging-based hernia classification.