The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair

Not Applicable

• Conditions: Laparoscopic Inguinal Hernia Repair
• Interventions: Other: self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia

• Registration Number: NCT04394338
• Lead Sponsor: Mahidol University

Brief Summary

Inguinal hernia is one of the most-common surgical conditions. Incidence is about 27% in males and 3% in females.The treatment of this condition is inguinal hernia repair operation which can be approached with several techniques; open hernia repair, laparoscopic hernia repair and robotic hernia repair. The current guidelines recommend the hernia repair operation with mesh placement either Lichtenstenstein operation or laparoscopic technique; transabdominal preperitoneal technique (TAPP) and totally extraperitoneal technique (TEP). In the laparoscopic approach, one of the complications that can occur is post-operative pain from the mesh fixator. So the self-gripping mesh becomes another option to decrease this incidence.However the adhesive property of the mesh is still challenging for many surgeons. Several techniques of self-gripping mesh placement were introduced. One of the popular techniques is bilateral vertical folding of self-gripping mesh which still causes some adhesive problems when introduced to the target area. This research's aim is to present a new technique of the self-gripping mesh placement which is more effective, more convenient, and decreases the time taken to place the mesh at the surgery site.

Detailed Description

A randomized control trail comparing the duration of mesh placement and surgeon satisfaction of self-gripping mesh with plastic sheath and with non-plastic sheath covering mesh. Patients with groin hernia who planned for elective laparoscopically repair hernia with self-gripping mesh at Ramathibodi Hospital, Faculty of Medicine, Mahidol University will are informed of the details of research at the outpatient department before admission. 1:1 open label randomization trail was designed dividing the patients into two groups by the study number. The operation will be done with the standard laparoscopic hernia repair technique by experienced surgeons.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-17
• Study First Posted: 2020-05-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Elective laparoscopic inguinal hernia repair

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Exclusion Criteria

• Rejected or withdrawn consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plastic sheath covering	self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia	plastic sheath was prepared with the standard 9 cmx15cm self-gripping mesh. Then the meshe were folded and unfolded over or under the plastic sheaths in different directions.

Primary Outcome Measures

Name	Time	Method
Duration	5 min	the duration of self-gripping mesh placement with plastic sheath

Secondary Outcome Measures

Name	Time	Method
wound infection	30 days	wound infection
post operative pain: pain scores	24 hours after surgery	During a preoperative visit, the patients are introduced to the concept of the visual analogue scale (VAS), which ranges from 0 = no pain to 10 = worst pain. The measure pain scores (Visual Analog Scale) in the postoperative period.

Trial Locations

Locations (1)

Chairat Supsamutchai; 🇹🇭 Bangkok, Bankok, Thailand