Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KKSK-4711
Study information
Scientific title
Acronym
LAPSIS
Study hypothesis
1. Surgisis Gold (perforated) is non-inferior as compared to conventional meshes
2. Laparoscopic is superior to open ventral hernia repair in regards of the development of major complications
Ethics approval
Added 30/09/2013: Medical Ethics Committee of the UZ KULeuven, 17/01/2005, ref: ML2925
Study design
Multicenter two factorial randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary or incisional ventral hernia
Intervention
Collagen mesh (Surgisis Gold® [perforated]) versus conventional mesh and laparoscopic versus open ventral hernia repair.
Updated 10/09/2009: this trial has stopped recruiting and the last patient was randomised on 21/07/2009. Follow-up is ongoing for the next three years and the date of last patient out (LPO) is anticipated for August 2012. The anticipated end date of this trial was changed from 31/05/2009 to reflect this.
Updated 13/09/2013: follow-up has ended and the database has been locked.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Major complication (hernia recurrence, prosthetic infection, re-operation) rate within three years after surgery
Secondary outcome measures
1. Early (first 30 days postoperatively) and late (up to three years postoperatively) local complication rate (wound infection, wound dehiscence, wound sinus, fistula formation, bleeding, hematoma, seroma formation, peritonitis, mechanical obstruction, ileus, other)
2. Early (first 30 days postoperatively) general complication rate (all adverse events other than listed under local complications: thromboembolic events, cardiac, respiratory, other)
3. Time to failure (= major complication)
4. Chronic abdominal wall pain (Von Korff chronic pain questionnaire; preoperatively, one and three years postoperatively
5. Chronic discomfort e.g. abdominal wall stiffness (visual analogue scale [VAS]; preoperatively and three years postoperatively)
6. Mortality (up to three years postoperatively)
7. Incidence of and cause for conversion in the laparoscopy group
Overall trial start date
01/07/2005
Overall trial end date
31/08/2012
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Elective repair of ventral (including umbilical) hernia with need for mesh repair
2. Age ≥18 years
3. Male and female patients may participate
4. Minimal hernia orifice diameter ≥4 cm
5. Largest hernia orifice ≤10 cm
6. Eligibility to laparoscopic mesh repair
7. Written informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
660
Participant exclusion criteria
1. Medical or surgical contraindication to general anesthesia
2. Severe comorbidity (American Society of Anesthesiologists [ASA] physical status classification ≥4)
3. Pregnancy
4. Emergency surgery for incarcerated irreducible hernia
5. Previous mesh repair at the same site
6. Hernia orifice <3 cm away from costal margin/sternum and/or pubis
7. Lumbar hernia
8. Parastomal hernia
9. Need for more than one mesh covering the hernia orifice
10. Need for a mesh larger than 20 cm x 20 cm or 22 cm x 13 cm
11. Crohns disease
12. Life expectancy less than 12 months
13. Chemotherapy within the last four weeks
14. Radiotherapy within the last two months
15. Previous abdominal radiotherapy
16. Known allergy against porcine materials
17. Marfans syndrome
18. Child B or C liver disease
19. Morbid obesity (body mass index [BMI] ≥40 kg/m^2)
20. Non-compliance
21. Simultaneous participation in other interventional trials interfering with one of the approaches in this trial
22. Previous participation in this trial
Recruitment start date
01/07/2005
Recruitment end date
31/08/2012
Locations
Countries of recruitment
Austria, Belgium, Croatia, Denmark, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal
Trial participating centre
Herestraat 49
Leuven
3000
Belgium
Funders
Funder type
Industry
Funder name
Cook Biotech Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list