Parastomal HerniaNCT00908661
Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
A study testing Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh in people with Parastomal Hernia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2007to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with permanent ostomy and 1 years of life expectancy
- Signed informed consent
Who cannot join
- Allergy to the compounds of the mesh
- Rejection of the patient
- Rejection of the surgeon
- Field of emergency
- Life expectancy < 1 year
- Prior meshes in the surgical site
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Valldhebron Research Institute
Barcelona, Barcelona, 08035
About this study
Official title: Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach
The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.
Read the detailed description
Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.
Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.
- Conditions
- Parastomal Hernia
- Being tested
- Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
- Keywords
- Parastomal, hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose meshDevice
Also called PROCEED mesh
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic mesh | Active comparator | All patients will have a permanent ostomy and a randomisation with prophylactic mesh Receives: Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh |
| without prophylactic mesh | No intervention | All patients will have a permanent ostomy and a randomisation without prophylactic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Measured: 24 to 36 months after surgery
Secondary outcomes (1)
Measuring the quality of life using the SF-36
Measured: Preoperative and at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startNov 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908661
- Sponsor's protocol ID
- PR(AG)116/2006
- Status last verified
- Mar 2011
- First submitted
- 25 May 2009
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.
PubMed 19300232Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.
PubMed 19502871Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.
PubMed 22782367
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach
- ClinicalTrials.gov ID
- NCT00908661
- Acronym / sponsor ID
- PR(AG)116/2006
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal, hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.
Detailed description
Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.
Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic mesh | Active comparator | Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose meshAll patients will have a permanent ostomy and a randomisation with prophylactic mesh |
| without prophylactic mesh | No intervention | –All patients will have a permanent ostomy and a randomisation without prophylactic mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with permanent ostomy and 1 years of life expectancy
- Signed informed consent
Key exclusion criteria (6 listed)
- Allergy to the compounds of the mesh
- Rejection of the patient
- Rejection of the surgeon
- Field of emergency
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose meshAlso: PROCEED meshLightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh | Device | Prophylactic mesh |
Primary outcome
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Time frame: 24 to 36 months after surgery
1 secondary outcome
Measuring the quality of life using the SF-36
Time frame: Preoperative and at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Background: PubMed 19300232Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.
- Background: PubMed 19502871Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.
- Derived from this study: PubMed 22782367Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh in people with Parastomal Hernia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done (time frame: 24 to 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908661, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.