An observational study in Primary Unilateral Inguinal Hernias, sponsored by University Hospital, Ghent. Completed at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by University Hospital, Ghent · Observational
A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair.
Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).
Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.
Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 101 is below the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients undergoing laparoscopic unilateral inguinal hernia repair
Exclusion Criteria:
TAPP repair for inguinal hernia
Procedure: TAPP repair for inguinal hernias · Other: EuraHS-QoL questionnaire · Other: Carolina Comfort Scale
TEP repair for inguinal hernia
Procedure: TEP repair for inguinal hernia · Other: EuraHS-QoL questionnaire · Other: Carolina Comfort Scale
questionnaire administration
questionnaire administration
assessment of the EuraHS-QoL
questionnaire assessment
Time frame: 1 year after start study
change in EuraHS-QoL assessment
clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score.
Time frame: preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent