Laparoscopic versus Open Ventral Hernia repair using a classical versus Collagen MESH (Surgisis Gold®): a European Multicenter Two Factorial Randomized Controlled Trial (LAPSIS Trial)

ISRCTN ISRCTN34532248
DOI https://doi.org/10.1186/ISRCTN34532248
Secondary identifying numbers KKSK-4711
Submission date
22/06/2005
Registration date
15/09/2005
Last edited
18/12/2020
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marc Miserez
Scientific

Herestraat 49
Leuven
3000
Belgium

Study information

Study designMulticenter two factorial randomised controlled trial
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleLaparoscopic versus Open Ventral Hernia repair using a classical versus Collagen MESH (Surgisis Gold®): a European Multicenter Two Factorial Randomized Controlled Trial (LAPSIS Trial)
Study acronymLAPSIS
Study objectives1. 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(s)Added 30/09/2013: Medical Ethics Committee of the UZ KULeuven, 17/01/2005, ref: ML2925
Health condition(s) or problem(s) studiedPrimary or incisional ventral hernia
InterventionCollagen 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 typeProcedure/Surgery
Primary outcome measureMajor complication (hernia recurrence, prosthetic infection, re-operation) rate within three years after surgery
Secondary outcome measures1. 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 study start date01/07/2005
Completion date31/08/2012
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants660
Total final enrolment253
Key inclusion criteria1. 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
Key exclusion criteria1. 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. Crohn’s 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. Marfan’s 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
Date of first enrolment01/07/2005
Date of final enrolment31/08/2012

Locations

Countries of recruitment

  • Austria
  • Belgium
  • Croatia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal

Study participating centre

Herestraat 49
Leuven
3000
Belgium

Sponsor information

Individual Sponsor (Germany)
Other

Prof Dr Edmund Neugebauer
Ostmerheimer Str. 200
Cologne
51109
Germany

Funders

Funder type

Industry

Cook Biotech Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2021 18/12/2020 Yes No

Editorial Notes

18/12/2020: Publication reference and total final enrolment added.

BMC - Part of Springer Nature Springer Nature