Clinical Trials Logo
  1. Home
  2. Ventral Hernia
  3. NCT01109771
  4. Details
NCT01109771 Clinical Trial

Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair

Ventral Hernia Clinical Trial

— SORBET  

Official title:
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01109771
Other study ID # 2008/702
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2010
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

To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.

Recruitment information / eligibility
Status Completed
Enrollment 105
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: - written informed consent from the adult patient (18 years and older, no maximum age) - primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair Exclusion Criteria: - no written informed consent - hernia defects larger than 10cm diameter in width - 'hostile' abdomen; open abdomen treatment - contraindication to pneumoperitoneum - emergency surgery (incarcerated hernia) - lateral or parastomal hernia sites

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• permanent mesh fixation
Permanent mesh fixation will be used.
• absorbable mesh fixation
Absorbable mesh fixation will be used.

Locations
Country Name City State
Belgium Imelda Ziekenhuis Bonheiden
Belgium CHU Charleroi Charleroi
Belgium St-Vincentius Ziekenhuis Deinze
Belgium AZ Sint-Dymphna Geel
Belgium University Hospital Ghent Ghent
Belgium Virga Jesseziekenhuis Hasselt Limburg
Belgium Ziekenhuis Maas en Kempen Maaseik
Belgium AZ Sint-Maarten Mechelen
Belgium Heilig Hart Ziekenhuis Mol
Belgium UCL Mont-Godinne Mont-Godinne
Belgium H. Serruys Ziekenhuis Oostende

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Medtronic - MITG

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of patients with a VAS scale more than 40 1 year after surgery
Secondary number of invasive interventions (local infiltrations, reoperations) postoperatively 1 year after surgery
Secondary number of patients taking analgetics 1 year post-surgery
Secondary perioperative morbidity rate 1 year after surgery
Secondary quality of life 1 year post-surgery
Secondary recurrence rate 1 year post-surgery
See also
  Status Clinical Trial Phase
Recruiting NCT06016426 - Mass Closure vs Layer by Layer Closure N/A
Recruiting NCT05572021 - A Comparison of the Outcomes in Fortiva and Strattice Mesh N/A
Completed NCT02263625 - Regional Differences In Indication for Ventral Hernia Repair
Completed NCT02292264 - Risk Factors and Complications of Ventral Hernia Repair
Completed NCT02263599 - Conservative Treatment For Ventral Hernia
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT01325246 - Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair N/A
Completed NCT03283982 - Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM N/A
Not yet recruiting NCT05526209 - Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Recruiting NCT04173884 - Video-based Collaborative Learning to Improve Ventral Hernia Repair N/A
Recruiting NCT02703662 - Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction Phase 2/Phase 3
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Completed NCT01719718 - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair N/A
Completed NCT03342040 - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair N/A
Completed NCT04150796 - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias N/A
Recruiting NCT03222102 - Ventral Hernia Prevention After Liver Transplantation N/A
Completed NCT05610267 - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A

External Links