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

NCT ID: NCT04394338

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-03-01

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.

Conditions

Laparoscopic Inguinal Hernia Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

mesh placement without plastic sheath

self-gripping mesh were placed without plastic sheath.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Elective laparoscopic inguinal hernia repair

Exclusion Criteria

• Rejected or withdrawn consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramathibodi Hospital

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chairat Supsamutchai, MD

Role: STUDY_CHAIR

Ramathibodi Hospital, Mahidol University

Locations

Chairat Supsamutchai

Bangkok, Bankok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Chairat Supsamutchai, MD

Role: CONTACT

pogeneral2007@hotmai.com

66) 0851156958

Chumpon Wilasrusmee, MD

Role: CONTACT

chumpon.wil@mahidol.ac.th

(66)22011527 ext. 245

Facility Contacts

Chairat Supsamutchai, MD

Role: primary

pogeneral2007@hotmail.com

022011527 ext. 245

Chumpon Wilasrusmee, MD

Role: backup

chumpon.wil@mahidol.ac.th

022011527 ext. 145

Other Identifiers

MURA2020/184

Identifier Type: -

Identifier Source: org_study_id