Condition category
Surgery
Date applied
22/06/2005
Date assigned
15/09/2005
Last edited
30/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marc Miserez

ORCID ID

Contact details

Herestraat 49
Leuven
3000
Belgium

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 measures

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

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. 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

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

Sponsor information

Organisation

Individual Sponsor (Germany)

Sponsor details

Prof Dr Edmund Neugebauer
Ostmerheimer Str. 200
Cologne
51109
Germany

Sponsor type

Other

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes