Efficacy evaluation of a low weight prosthetic mesh in the prevention of incisional hernia in patients undergoing medial laparotomy surgery
| ISRCTN | ISRCTN98336745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98336745 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/08/2009
- Registration date
- 22/10/2009
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vicente Vicente
Scientific
Scientific
General Surgery Department
University Hospital Joan XXIII de Tarragona
C/ Dr. Mallafre Guasch nº 4
Tarragona
43007
Spain
| drvicentevicente@hotmail.es |
Study information
| Study design | Prospective randomised simple blind parallel group single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy evaluation of a low weight prosthetic mesh in the prevention of incisional hernia in patients undergoing medial laparotomy surgery: a prospective randomised single-blind parallel group single centre trial |
| Study objectives | Placemet of a low weight prosthetic mesh can prevent or reduce the ocurrence of incisional hernia in patients requiring medial laparotomy surgery. |
| Ethics approval(s) | Ethics Committee of the University Hospital Joan XXIII Tarragona, 27/04/2009 |
| Health condition(s) or problem(s) studied | Incisional hernia |
| Intervention | Intervention group: At the end of the surgery we close the abdominal fascia with a continuous suture and a low weight polypropilene prosthetic mesh is placed 3 cm above the end zone attached to the aponeurosis with continous sutures. Control group: At the end of the surgery we close the abdominal fascia with a continuous suture only. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Physical exploration in series controls, in one week, one month, three months, six months, one year and two years 2. Computed tomography (CT) scan in doubt cases |
| Secondary outcome measures | 36-item short form health survey (SF-36) quality of life test at baseline, one month, six months and one year |
| Overall study start date | 01/05/2009 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 71 patients in the control group and 71 patients in the mesh group |
| Key inclusion criteria | 1. All patients aged between 18 and 80 years, both sexes, requiring digestive surgery in our hospital, by a medial laparotomy 2. American Society of Anaesthesiology (ASA) less than grade IV |
| Key exclusion criteria | 1. Allergic to polypropilene 2. Previous prosthetic mesh for a previous incisional hernia 3. Any ostomy in the abdominal wall 4. ASA greater than or equal to grade 4 5. Living prognosis less than 12 months 6. Corticotherapy 7. Haemodialysis |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
University Hospital Joan XXIII de Tarragona
Tarragona
43007
Spain
43007
Spain
Sponsor information
University Hospital Joan XXIII de Tarragona (Spain)
Hospital/treatment centre
Hospital/treatment centre
General Surgery Department
Dr. Mallafre Guasch nº 4
Tarragona
43007
Spain
"ROR" |
https://ror.org/05s4b1t72 |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospital Joan XXIII de Tarragona (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2014 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No | |
| Results article | results | 01/04/2019 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added.
