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NCT00323674 Clinical Trial

Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

Hernia, Inguinal Clinical Trial

Official title:
Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00323674
Other study ID # 2006/080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2006
Est. completion date August 31, 2015

Study information
Verified date August 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Recruitment information / eligibility
Status Completed
Enrollment 278
Est. completion date August 31, 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Symptomatic hernia inguinalis - > 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Polysoft Mesh
Polysoft Mesh is used.
• Light Weight Mesh
Light Weight Mesh is used.

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of relapse Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Primary Postoperative pain assessment Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Primary Duration to full recovery (able to do all activities) Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
See also
  Status Clinical Trial Phase
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Completed NCT01421602 - A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Recruiting NCT01830452 - Less Chronic Pain After Lichtenstein Hernioplasty Using the Self-gripping Parietex Progrip Mesh Phase 4
Completed NCT00130091 - The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children Phase 2
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
Recruiting NCT03041948 - Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair N/A
Completed NCT02751190 - Chronic Pain After Groin Hernia Repair N/A
Completed NCT04228536 - Chronic Pain After Groin Hernia Surgery in Women
Completed NCT04839848 - Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
Recruiting NCT02011698 - Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial N/A
Completed NCT00749268 - AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair Phase 4
Completed NCT00827944 - Parietex Progrip Study Phase 4
Recruiting NCT03673163 - Lidocaine Infusion for Pain After Herniotomy N/A
Terminated NCT00735124 - Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy Phase 2/Phase 3
Recruiting NCT05323552 - Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.
Completed NCT03326700 - Effects of Hernia Repair on Men's Sexual Functions N/A
Completed NCT02616406 - Objective Measure of Recovery After Outpatient Surgery
Recruiting NCT05839587 - Transabdominal Preperitoneal Inguinal Hernia Repair N/A
Completed NCT03392636 - Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years N/A
Completed NCT05600296 - Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block Phase 1

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