Laparoscopic Inguinal Hernia RepairNCT04394338
The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
A study testing self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia in people with Laparoscopic Inguinal Hernia Repair, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Inguinal Hernia Repair
- What is being tested?
- self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic inguinal hernia repair
Who cannot join
- Rejected or withdrawn consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia
- Keywords
- inguinal hernia repair, laparoscopic inguinal hernia repair, self-gripping mesh placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-gripping mesh placement with plastic sheath in laparoscopic inguinal herniaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh placement time
The duration from the introduction of the self-gripping mesh into the preperitoneal space until the completion of its final placement.
Measured: During the surgical procedure
Secondary outcomes (2)
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.
Measured: 24 hours after surgery
wound infection
wound infection
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Inguinal Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor
- Investigators
- Chairat Supsamutchai, MD, Study chair, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394338
- Sponsor's protocol ID
- MURA2020/184
- Status last verified
- Jul 2026
- First submitted
- 7 May 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04394338
- Acronym / sponsor ID
- MURA2020/184
- Conditions
- Laparoscopic Inguinal Hernia Repair
- Keywords
- inguinal hernia repair, laparoscopic inguinal hernia repair, self-gripping mesh placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| plastic sheath covering | Active comparator | Other: self-gripping mesh placement with plastic sheath in laparoscopic inguinal herniaplastic 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. |
| mesh placement without plastic sheath | No intervention | –self-gripping mesh were placed without plastic sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopic inguinal hernia repair
Key exclusion criteria (1 listed)
- Rejected or withdrawn consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-gripping mesh placement with plastic sheath in laparoscopic inguinal herniato 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. | Other | plastic sheath covering |
Primary outcome
Mesh placement time
Time frame: During the surgical procedure
The duration from the introduction of the self-gripping mesh into the preperitoneal space until the completion of its final placement.
2 secondary outcomes
post operative pain: pain scores
Time frame: 24 hours after surgery
wound infection
Time frame: 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chairat Supsamutchai, MD study chair
Ramathibodi Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia in people with Laparoscopic Inguinal Hernia Repair, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesh placement time (time frame: During the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.