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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04394338
Enrollment
60
Registered
2020-05-19
Start date
2020-02-01
Completion date
2021-12-31
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Inguinal Hernia Repair

Keywords

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

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.

Interventions

OTHERself-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.

Sponsors

Mahidol University
Lead SponsorOTHER
Ramathibodi Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective laparoscopic inguinal hernia repair

Exclusion criteria

* Rejected or withdrawn consent

Design outcomes

Primary

MeasureTime frameDescription
Mesh placement timeDuring the surgical procedureThe duration from the introduction of the self-gripping mesh into the preperitoneal space until the completion of its final placement.

Secondary

MeasureTime frameDescription
post operative pain: pain scores24 hours after surgeryDuring 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.
wound infection30 days post-surgerywound infection

Countries

Thailand

Contacts

STUDY_CHAIRChairat Supsamutchai, MD

Ramathibodi Hospital, Mahidol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026