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ACTIVE NOT RECRUITING

NCT07902167

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

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

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

Official title: Evaluating the Effectiveness and Safety of Laparoscopic Non-mesh Hernia Needle Set

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-04

Completion Date

2027-04-30

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Inguinal Hernia, Without Mention of Obstruction or Gangrene

Interventions

DEVICE

non-mesh inguinal hernia needle

Non-mesh inguinal hernia needle is used for indirect inguinal hernia repair by laparoscopy. It is composed of puncture needle and suture needle.

DEVICE

conventional needle set

Conventional needle set is used traditionally for percutaneous internal ring suture in Chang Gung Memorial Hospital at Chiayi, Taiwan.

Inclusion Criteria: * Participant is willing and able to give written informed consent for participation in the trial. * Adults (more than 18 years old) with inguinal hernia. * Do not want to undergo traditional open hernia surgery, but willing to undergo single-port laparoscopy to determine the hernia type. * For the indirect hernia, the participant is willing to undergo percutaneous internal ring suture by using either the ready-made or neoteric needle set decided by us randomly. * If employees or students of the study institution are considered for participation, they may be enrolled only if all of the following conditions are met: 1. They satisfy all inclusion criteria specified in this study protocol. 2. The investigator and research personnel involved in recruitment are not the participant's direct supervisor, instructor, or evaluator, and have no responsibility for assessing the participant's academic, employment, or professional performance. 3. Recruitment is conducted in a manner that minimizes the possibility of coercion or undue influence. Participants shall not be recruited through individual solicitation by their supervisors, instructors, or evaluators. Exclusion Criteria: * Pregnant women. * Obesity: Body mass index (BMI) ≧35. * Recurrent hernia after any hernia surgery. * Insufficient level of language to understand all study requirements in opinion of the investigators. * Hydroceles with multiple septations and complex anatomy. * Incarcerated or strangulated hernias. * Known connective tissue disorders (e.g., Loeys-Dietz, Marfan syndrome). * High bleeding tendency during surgery. * Technical conversion triggers: large hernias, edema, poor visualization. * Severe cardiopulmonary compromise. * Extensive intra-abdominal adhesions (e.g., from prior surgeries or infections). * Allergy to the materials of the medical devices used in this study (such as stainless steel and suture materials). * Patients asked for mesh repair for their inguinal hernia initially.

Locations (1)

Chang Gung Memorial Hospital

Chiayi City, Taiwan