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

NCT04394338 | Unknown

• 1 other identifier: MURA2020/184
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Inguinal Hernia Repair

Keywords

inguinal hernia repair; laparoscopic inguinal hernia repair; self-gripping mesh placement

Outcome Measures

Primary Outcomes (1)

• Duration

  the duration of self-gripping mesh placement with plastic sheath

  5 min

Secondary Outcomes (2)

• post operative pain: pain scores

  24 hours after surgery

• wound infection

  30 days

Study Arms (2)

plastic sheath covering

ACTIVE COMPARATOR

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

mesh placement without plastic sheath

NO INTERVENTION

self-gripping mesh were placed without plastic sheath.

Interventions

self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia OTHER

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.

plastic sheath covering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective laparoscopic inguinal hernia repair

You may not qualify if:

• Rejected or withdrawn consent

Sponsors & Collaborators

• Mahidol University: lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

RECRUITING

Study Officials

• Chairat Supsamutchai, MD

  Ramathibodi Hospital, Mahidol University

  STUDY CHAIR

Central Study Contacts

Chairat Supsamutchai, MD

CONTACT

66) 0851156958; pogeneral2007@hotmai.com

Chumpon Wilasrusmee, MD

CONTACT

(66)22011527; chumpon.wil@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 7, 2020
• First Posted: May 19, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)