3 Fixation Devices in Laparoscopic Ventral Herniotomy
FS
A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
1 other identifier
interventional
75
1 country
1
Brief Summary
Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh. Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 19, 2020
February 1, 2020
4.3 years
February 9, 2012
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
Dolo Test (VAS)
1 measurement, 2nd postoperative day
Secondary Outcomes (3)
hernia recurrence
7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
quality of life
7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Pain
7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
Study Arms (3)
fixation with Protack
EXPERIMENTALfixation with Securestrap
EXPERIMENTALfixation with Glubran
EXPERIMENTALsurgery
Interventions
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
Eligibility Criteria
You may qualify if:
- ventral hernia 2(1,5) \< dia \> 7 cm
- danish speaking
- of sound mind
- bmi \< 35
- ASA 3 or less, no contra indication against laparoscopy
You may not qualify if:
- other size hernias,
- no danish,
- bmi \> 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Horsens Hospitallead
- Randers Regional Hospitalcollaborator
Study Sites (1)
Regional Hospital Horsens
Horsens, 8700, Denmark
Related Publications (1)
Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25.
PMID: 29799075DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sanne S Harsløf, MD
Regionshospitalet Horsens
- STUDY DIRECTOR
Thorbjørn Sommer, MD, PhD
Randers Regional Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 17, 2012
Study Start
April 1, 2013
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
February 19, 2020
Record last verified: 2020-02