Parastomal HerniaPhase 3RPMPPHNCT01955278
Role of Prosthetic Mesh in Preventing Parastomal Hernias
A Phase 3 study testing Definitive end colostomy with mesh and Conventional definitive end colostomy in people with Parastomal Hernia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Definitive end colostomy with mesh and Conventional definitive end colostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Oct 2016
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal disease that require realization of definitive end colostomy
- Laparoscopy assisted interventions
- Interventions intended to radical treatment in case of oncologic pathology
- Signed informed consent by the patient or representative in case of incapacity
Who cannot join
- No acceptance to participate or inability to obtain signed informed consent
- Urgent interventions
- Palliative interventions
- Lateral colostomies
- American Society of Anesthesiologists (ASA) Classification IV-V
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Santa Creu i Sant Pau
Barcelona, 08040
Ozlem Uyanik, MD, 0034677840299, ouyanik@santpau.cat
Ozlem Uyanik, MD
About this study
Official title: Prospective Randomized Study of the Role of Prosthetic Mesh in Preventing Parastomal Hernias in Patients With Definitive End Colostomy
Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3).
Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8).
Read more
The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support.
Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro.
Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique.
Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period.
Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.
Read the detailed description
Definition of parastomal hernia
Parastomal hernia is considered if it happens one of the following situations:
- Parastomal protrusion spontaneously or with Valsalva maneuver, evidenced by observation and palpation, exploring the patient at supine and standing position
- Protrusion of intrabdominal contents through the fascial hole, evidenced by abdominal computed tomography, in cases without clinical evidence of hernia or in obese patient whose exploration is difficult. For the description of parastomal hernias will be used the clinico-radiological classification described by Moreno et al. (12).
Ethical Issues The study is approved by the regional ethics committee. The patients candidates for the study will be informed in person by a surgeon of the team and will receive written information. Informed consent will be obtained from each patient according to the guidelines established by the ethics committee prior to randomization into the study. Patients will be free to leave the study at any time.
To ensure the optimal treatment for patients in each arm of the study, analysis will be conducted throughout the inclusion process to compare the incidence of parastomal hernias, specific morbidity and mortality specific related to the use of prosthetic mesh. If the observed differences were significant, we would stop the study.
Patient Selection Inclusion criteria
- Patients with colorectal disease that require realization of definitive end colostomy
- Laparoscopy assisted interventions
- Interventions intended to radical treatment in case of oncologic pathology
- Signed informed consent by the patient or representative in case of incapacity
Exclusion criteria
- No acceptance to participate or inability to obtain signed informed consent
- Urgent interventions
- Palliative interventions
- Lateral colostomies
- American Society of Anesthesiologists (ASA) Classification IV-V
Randomization and Statistical Analysis The incidence of parastomal hernia according to the literature is around 50%. Furthermore, according to the prospective randomized studies performed with prophylactic mesh, the incidence varies between 5% and 22% depending on the follow-up period and the definition used (4-6,8,10,12).
In the control group the incidence of the problem is approximately 50% of cases and the incidence in the prophylactic mesh group is about 15%.
With these results, setting the value of the type I error at 5% (α = 0.05), with bilateral approximation and considering an estimated loss of 5% during the fallow up, the number of patients is 30 in each group (power will be above 80%).
In case of meeting all the inclusion criteria and accepted by the patient, randomization will be:
Group A: Conventional definitive end colostomy Group B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro
Randomization will be performed by computer-generated sequence and concealment of the randomization order will be made using sealed opaque envelopes. The technique to be used in each case will be known at the time of the intervention by opening the envelope in order during the surgery.
Actuarial analysis of morbidity, mortality and recurrence index will be performed during the study (every 30 patients included). The analysis will be done by intention to treat and effective treatment.
Technical Aspects In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.
Perioperative Care Preoperative: Colon preparation, antibiotic and thromboembolic prophylaxis will be carried out in accordance with the standards of the center and will be applied equally in both study arms. In each patient the colostomy site will be marked on the abdomen the day before surgery, by the stoma therapist.
Intraoperative: Anesthesia will be conducted according to the standards of the center and will be applied equally in both study arms.
Postoperative: In accordance with the standards of our center it will be applied in all patients.
Fallow up Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year.
Expected Results Statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation.
- Conditions
- Parastomal Hernia
- Being tested
- Definitive end colostomy with mesh, Conventional definitive end colostomy
- Keywords
- Laparoscopic colorectal surgery, Parastomal hernia, Prophylactic, Mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive end colostomy with meshDevice
Also called synthetic prosthetic mesh, low weight type, Ultrapro, 15x15 cm
In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.
Conventional definitive end colostomyOther
| Study group | Role | What they receive |
|---|---|---|
| Creation of defitinive end colostomy | Experimental | Patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy Receives: Device: Definitive end colostomy with mesh; Other: Conventional definitive end colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the incidence of parastomal hernias between groups
Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year.
The expected result is the statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation
Measured: During the monitoring period of one year
Secondary outcomes (3)
Compare the overall and specific postoperative morbidity and mortality between groups
Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year
Measured: During the monitoring period of one year
Compare the difference in surgical time between the conventional technique and the prosthetic mesh group
The duration of the surgery will be compared bentween the groups
Measured: During the surgery
Compare hospital stay between the groups
Days of hospital stay will be compared between the groups
Measured: Patientes will be followed for the duration of hospital stay, an expected average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Targarona, MD, Study director, Hospital de Santa Creu i Sant Pau, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955278
- Sponsor's protocol ID
- HSCSP10070PPHP
- Acronym
- RPMPPH
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2013
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
PubMed 15613293Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
PubMed 19011935Gogenur I, Mortensen J, Harvald T, Rosenberg J, Fischer A. Prevention of parastomal hernia by placement of a polypropylene mesh at the primary operation. Dis Colon Rectum. 2006 Aug;49(8):1131-5. doi: 10.1007/s10350-006-0615-1.
PubMed 16826330Helgstrand F, Gogenur I, Rosenberg J. Prevention of parastomal hernia by the placement of a mesh at the primary operation. Hernia. 2008 Dec;12(6):577-82. doi: 10.1007/s10029-008-0387-8. Epub 2008 Jun 4.
PubMed 18523836Vijayasekar C, Marimuthu K, Jadhav V, Mathew G. Parastomal hernia: Is prevention better than cure? Use of preperitoneal polypropylene mesh at the time of stoma formation. Tech Coloproctol. 2008 Dec;12(4):309-13. doi: 10.1007/s10151-008-0441-7. Epub 2008 Nov 18.
PubMed 19018469Lopez-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 19502871Berger D. Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay mesh (Dynamesh IPST). Hernia. 2008 Jun;12(3):243-6. doi: 10.1007/s10029-007-0318-0. Epub 2007 Dec 11.
PubMed 18071839Moreno-Matias J, Serra-Aracil X, Darnell-Martin A, Bombardo-Junca J, Mora-Lopez L, Alcantara-Moral M, Rebasa P, Ayguavives-Garnica I, Navarro-Soto S. The prevalence of parastomal hernia after formation of an end colostomy. A new clinico-radiological classification. Colorectal Dis. 2009 Feb;11(2):173-7. doi: 10.1111/j.1463-1318.2008.01564.x. Epub 2008 May 3.
PubMed 18462232Rubin MS, Schoetz DJ Jr, Matthews JB. Parastomal hernia. Is stoma relocation superior to fascial repair? Arch Surg. 1994 Apr;129(4):413-8; discussion 418-9. doi: 10.1001/archsurg.1994.01420280091011.
PubMed 8154967Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.
PubMed 15981038Goligher JC. Surgery of the anus, rectum and colon. 5th ed. London: Bailliere-Tindall; 1985.
Janson AR, Janes A, Israelsson LA. Laparoscopic stoma formation with a prophylactic prosthetic mesh. Hernia. 2010 Oct;14(5):495-8. doi: 10.1007/s10029-010-0673-0. Epub 2010 May 23.
PubMed 20496156
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of the Role of Prosthetic Mesh in Preventing Parastomal Hernias in Patients With Definitive End Colostomy
- ClinicalTrials.gov ID
- NCT01955278
- Acronym / sponsor ID
- RPMPPH / HSCSP10070PPHP
- Conditions
- Parastomal Hernia
- Keywords
- Laparoscopic colorectal surgery, Parastomal hernia, Prophylactic, Mesh
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 7 Oct 2013 (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 is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3).
Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8).
The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support.
Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro.
Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique.
Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period.
Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.
Detailed description
Definition of parastomal hernia
Parastomal hernia is considered if it happens one of the following situations:
- Parastomal protrusion spontaneously or with Valsalva maneuver, evidenced by observation and palpation, exploring the patient at supine and standing position
- Protrusion of intrabdominal contents through the fascial hole, evidenced by abdominal computed tomography, in cases without clinical evidence of hernia or in obese patient whose exploration is difficult. For the description of parastomal hernias will be used the clinico-radiological classification described by Moreno et al. (12).
Ethical Issues The study is approved by the regional ethics committee. The patients candidates for the study will be informed in person by a surgeon of the team and will receive written information. Informed consent will be obtained from each patient according to the guidelines established by the ethics committee prior to randomization into the study. Patients will be free to leave the study at any time.
To ensure the optimal treatment for patients in each arm of the study, analysis will be conducted throughout the inclusion process to compare the incidence of parastomal hernias, specific morbidity and mortality specific related to the use of prosthetic mesh. If the observed differences were significant, we would stop the study.
Patient Selection Inclusion criteria
- Patients with colorectal disease that require realization of definitive end colostomy
- Laparoscopy assisted interventions
- Interventions intended to radical treatment in case of oncologic pathology
- Signed informed consent by the patient or representative in case of incapacity
Exclusion criteria
- No acceptance to participate or inability to obtain signed informed consent
- Urgent interventions
- Palliative interventions
- Lateral colostomies
- American Society of Anesthesiologists (ASA) Classification IV-V
Randomization and Statistical Analysis The incidence of parastomal hernia according to the literature is around 50%. Furthermore, according to the prospective randomized studies performed with prophylactic mesh, the incidence varies between 5% and 22% depending on the follow-up period and the definition used (4-6,8,10,12).
In the control group the incidence of the problem is approximately 50% of cases and the incidence in the prophylactic mesh group is about 15%.
With these results, setting the value of the type I error at 5% (α = 0.05), with bilateral approximation and considering an estimated loss of 5% during the fallow up, the number of patients is 30 in each group (power will be above 80%).
In case of meeting all the inclusion criteria and accepted by the patient, randomization will be:
Group A: Conventional definitive end colostomy Group B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro
Randomization will be performed by computer-generated sequence and concealment of the randomization order will be made using sealed opaque envelopes. The technique to be used in each case will be known at the time of the intervention by opening the envelope in order during the surgery.
Actuarial analysis of morbidity, mortality and recurrence index will be performed during the study (every 30 patients included). The analysis will be done by intention to treat and effective treatment.
Technical Aspects In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.
Perioperative Care Preoperative: Colon preparation, antibiotic and thromboembolic prophylaxis will be carried out in accordance with the standards of the center and will be applied equally in both study arms. In each patient the colostomy site will be marked on the abdomen the day before surgery, by the stoma therapist.
Intraoperative: Anesthesia will be conducted according to the standards of the center and will be applied equally in both study arms.
Postoperative: In accordance with the standards of our center it will be applied in all patients.
Fallow up Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year.
Expected Results Statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creation of defitinive end colostomy | Experimental | Device: Definitive end colostomy with mesh, Other: Conventional definitive end colostomyPatients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with colorectal disease that require realization of definitive end colostomy
- Laparoscopy assisted interventions
- Interventions intended to radical treatment in case of oncologic pathology
- Signed informed consent by the patient or representative in case of incapacity
Key exclusion criteria (5 listed)
- No acceptance to participate or inability to obtain signed informed consent
- Urgent interventions
- Palliative interventions
- Lateral colostomies
- American Society of Anesthesiologists (ASA) Classification IV-V
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 |
|---|---|---|
| Definitive end colostomy with meshAlso: synthetic prosthetic mesh, low weight type, Ultrapro, 15x15 cmIn the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures. | Device | Creation of defitinive end colostomy |
| Conventional definitive end colostomy | Other | Creation of defitinive end colostomy |
Primary outcome
Compare the incidence of parastomal hernias between groups
Time frame: During the monitoring period of one year
Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year. The expected result is the statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation
3 secondary outcomes
Compare the overall and specific postoperative morbidity and mortality between groups
Time frame: During the monitoring period of one year
Compare the difference in surgical time between the conventional technique and the prosthetic mesh group
Time frame: During the surgery
Compare hospital stay between the groups
Time frame: Patientes will be followed for the duration of hospital stay, an expected average of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 15613293Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
- Background: PubMed 19011935Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
- Background: PubMed 16826330Gogenur I, Mortensen J, Harvald T, Rosenberg J, Fischer A. Prevention of parastomal hernia by placement of a polypropylene mesh at the primary operation. Dis Colon Rectum. 2006 Aug;49(8):1131-5. doi: 10.1007/s10350-006-0615-1.
- Background: PubMed 18523836Helgstrand F, Gogenur I, Rosenberg J. Prevention of parastomal hernia by the placement of a mesh at the primary operation. Hernia. 2008 Dec;12(6):577-82. doi: 10.1007/s10029-008-0387-8. Epub 2008 Jun 4.
- Background: PubMed 19018469Vijayasekar C, Marimuthu K, Jadhav V, Mathew G. Parastomal hernia: Is prevention better than cure? Use of preperitoneal polypropylene mesh at the time of stoma formation. Tech Coloproctol. 2008 Dec;12(4):309-13. doi: 10.1007/s10151-008-0441-7. Epub 2008 Nov 18.
- 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.
- Background: PubMed 18071839Berger D. Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay mesh (Dynamesh IPST). Hernia. 2008 Jun;12(3):243-6. doi: 10.1007/s10029-007-0318-0. Epub 2007 Dec 11.
- Background: PubMed 18462232Moreno-Matias J, Serra-Aracil X, Darnell-Martin A, Bombardo-Junca J, Mora-Lopez L, Alcantara-Moral M, Rebasa P, Ayguavives-Garnica I, Navarro-Soto S. The prevalence of parastomal hernia after formation of an end colostomy. A new clinico-radiological classification. Colorectal Dis. 2009 Feb;11(2):173-7. doi: 10.1111/j.1463-1318.2008.01564.x. Epub 2008 May 3.
- Results publication: PubMed 8154967Rubin MS, Schoetz DJ Jr, Matthews JB. Parastomal hernia. Is stoma relocation superior to fascial repair? Arch Surg. 1994 Apr;129(4):413-8; discussion 418-9. doi: 10.1001/archsurg.1994.01420280091011.
- Results publication: PubMed 15981038Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.
- Results publicationGoligher JC. Surgery of the anus, rectum and colon. 5th ed. London: Bailliere-Tindall; 1985.
- Results publication: PubMed 20496156Janson AR, Janes A, Israelsson LA. Laparoscopic stoma formation with a prophylactic prosthetic mesh. Hernia. 2010 Oct;14(5):495-8. doi: 10.1007/s10029-010-0673-0. Epub 2010 May 23.
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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.
Eduardo Targarona, MD study director
Hospital de Santa Creu i Sant Pau, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Definitive end colostomy with mesh and Conventional definitive end colostomy in people with Parastomal Hernia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 4 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: status not confirmed, as of the sponsor's last update on 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Uyanik, MD (0034677840299, ouyanik@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the incidence of parastomal hernias between groups (time frame: During the monitoring period of one year). 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 NCT01955278, which also lists 12 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 17 Sep 2015.