An interventional study of Tack fixation of mesh and Synthetic glue fixation in Inguinal Hernia, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Not applicable, Interventional, and Treatment
This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.
consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.
561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods with spiral tack is randomly assigned to one side, then comparative fixation method to the contralateral side. In group of active comparator, after randomization, the target inguinal hernia side of the patient has the mesh fixed with titanium spiral tacks.
Procedure: Tack fixation of mesh
The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.
Procedure: Synthetic glue fixation
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization
acute post-operative pain with VAS
Time frame: 6 hours after OP
Chronic pain VAS pain scale
Time frame: 6 months after OP
Questionnaire of complications
Time frame: 6 months after OP
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Nov 2016 and a primary completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation