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

Laparoscopic Inguinal Hernia Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394338
• Other study ID #: MURA2020/184
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: Chairat Supsamutchai, MD
• Phone: 66) 0851156958
• Email: pogeneral2007[@]hotmai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective laparoscopic inguinal hernia repair

Exclusion Criteria:

• Rejected or withdrawn consent

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Laparoscopic Inguinal Hernia Repair

Intervention

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.

Locations

Country	Name	City	State
Thailand	Chairat Supsamutchai	Bangkok	Bankok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration	the duration of self-gripping mesh placement with plastic sheath	5 min
Secondary	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
Secondary	wound infection	wound infection	30 days