Parastomal HerniaPhase 4NCT01722565
Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
A Phase 4 study testing laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25) in people with Parastomal Hernia, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2014
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation.
- Life expectancy above 12 months
Who cannot join
- - Patients with allergy or intolerance of the compounds in the mesh
- Carriers of prosthetic meshes in the area of the ostomy
- Patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach.
- Cirrhotic patients
- Patients with life expectancy below 12 months due to underlying disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Corporacion Sanitaria Universitaria Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients.
Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection.
Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.
- Conditions
- Parastomal Hernia
- Being tested
- laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)
- Keywords
- Parastomal hernias, Tolerance of lightweight meshes, laparoscopic abdominoperineal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mesh Group | Experimental | Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure Receives: Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25) |
| Control Group | No intervention | Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in the incidence of Parastomal Hernia after the mesh placement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Xavier Serra-Aracil, MD, Principal investigator, Corporacion Sanitaria Universitaria Parc TauliManuel Lopez-Cano, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722565
- Sponsor's protocol ID
- LAP-APR-2012-028
- Status last verified
- Sep 2015
- First submitted
- 4 Nov 2012
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
- ClinicalTrials.gov ID
- NCT01722565
- Acronym / sponsor ID
- LAP-APR-2012-028
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernias, Tolerance of lightweight meshes, laparoscopic abdominoperineal resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Nov 2012 (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.
Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients.
Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection.
Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh Group | Experimental | Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure |
| Control Group | No intervention | –Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation.
- Life expectancy above 12 months
Key exclusion criteria (5 listed)
- - Patients with allergy or intolerance of the compounds in the mesh
- Carriers of prosthetic meshes in the area of the ostomy
- Patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach.
- Cirrhotic patients
- Patients with life expectancy below 12 months due to underlying disease
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 |
|---|---|---|
| laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25) | Procedure or surgery | Mesh Group |
Primary outcome
The reduction in the incidence of Parastomal Hernia after the mesh placement
Time frame: 12 months
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 10 Sep 2015.
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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.
Xavier Serra-Aracil, MD principal investigator
Corporacion Sanitaria Universitaria Parc Tauli
Manuel Lopez-Cano, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25) in people with Parastomal Hernia, run by Corporacion Parc Tauli 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 5 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 10 Sep 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The reduction in the incidence of Parastomal Hernia after the mesh placement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2015.