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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Inguinal Hernia Repair
• Intervention / Treatment: Other: self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chairat Supsamutchai, MD; Phone Number: 66) 0851156958; Email: pogeneral2007@hotmai.com
• Study Contact Backup: Name: Chumpon Wilasrusmee, MD; Phone Number: 245 (66)22011527; Email: chumpon.wil@mahidol.ac.th

Study Locations

• Thailand
  • Bankok
    • Bangkok, Bankok, Thailand, 10400
      • Recruiting
      • Chairat Supsamutchai
      • Contact: Chairat Supsamutchai, MD; Phone Number: 245 022011527; Email: pogeneral2007@hotmail.com
      • Contact: Chumpon Wilasrusmee, MD; Phone Number: 145 022011527; Email: chumpon.wil@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective laparoscopic inguinal hernia repair

Exclusion Criteria:

• Rejected or withdrawn consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: plastic sheath covering; 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.	Other: self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia; to apply these to the mesh graft placement process. In the first step, plastic sheaths self-gripping mesh placement with plastic sheathwere prepared configuration with the standard 9cmx15cm self-gripping mesh. Then the meshes were folded and unfolded over or under the plastic sheaths.
No Intervention: mesh placement without plastic sheath; self-gripping mesh were placed without plastic sheath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration	the duration of self-gripping mesh placement with plastic sheath	5 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain: pain scores	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.	24 hours after surgery
wound infection	wound infection	30 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Ramathibodi Hospital
• Investigators: Study Chair: Chairat Supsamutchai, MD, Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: inguinal hernia repair; laparoscopic inguinal hernia repair; self-gripping mesh placement
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: MURA2020/184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No