Rectal CancerPhase 3BIOPEXNCT01927497
Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer
A Phase 3 study testing Biological mesh assisted perineal closure and Primary perineal closure in people with Rectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Biological mesh assisted perineal closure and Primary perineal closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Mar 2013to 1 Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age of 18 years or higher.
- Planned for eAPR for primary rectal cancer.
- Life expectancy of more than 2 years.
- Ability to return for all scheduled and required study visits.
- Preoperative (chemo)radiotherapy.
- Written informed consent for study participation.
Who cannot join
- Previous pelvic irradiation for other cancers (i.e. prostate cancer).
- Total exenteration or sacral resection above level S4/S5.
- Sensitivity to porcine derived products or polysorbate.
- Severe systemic diseases affecting wound healing (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV).
- Collagen disorders (i.e. Marfan).
- Enrolment in trials with overlapping primary endpoint or otherwise expected influence on wound healing (i.e. biological therapy like antiangiogenic agents).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Results of Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer
Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data.
Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy.
Read more
Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh.
Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized.
Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm.
Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.
- Conditions
- Rectal Cancer
- Being tested
- Biological mesh assisted perineal closure, Primary perineal closure
- Keywords
- Rectal cancer, Extralevator abdominoperineal resection, Biological Mesh, Primary closure
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological mesh assisted perineal closureProcedure or surgery
Also called Biological Mesh, Strattice™, Strattice® Reconstructive Tissue Matrix, Lifecell
The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm.
Primary perineal closureProcedure or surgery
Also called Primary closure, Perineal wound closure
The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Biological mesh closure | Experimental | Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection Receives: Procedure: Biological mesh assisted perineal closure |
| Primary perineal closure | Active comparator | Primary perineal closure after extralevator abdomino perineal resection Receives: Procedure: Primary perineal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Uncomplicated Perineal Wound Healing
uncomplicated perineal wound healing is defined as a Souphampton wound score less than II
Measured: From operation to 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study start8 Mar 2013
- Primary completion1 Sep 2014
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCell
- Responsible party
- Principal investigator, P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Gijsbert D. Musters, M.D., Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Willem A. Bemelman, Prof, PhD, M.D., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Harm J. Rutten, M.D. PhD, Principal investigator, Catharina Ziekenhuis EindhovenBaljit Singh, M.D. PhD, Principal investigator, Leicester hospital, LeicesterMarcel G.W. Dijkgraaf, M.D., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927497
- Sponsor's protocol ID
- METC 2012_360
- Other IDs
- NTR3717
- Acronym
- BIOPEX
- Status last verified
- Jul 2021
- First submitted
- 19 Aug 2013
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
van den Berg R, Musters GD, Verhoef C, Sharabiany S, Hompes R, Singh B, Chaudhri SS, van Geloven AAW, Vuylsteke RJCLM, de Wilt JHW, Leijtens JWA, Vermaas M, Rothbarth J, Burger JWA, Lamme B, van de Ven A, Blommestein HM, Tanis PJ. Cost-Effectiveness of Pelvic Floor Reconstruction Using Biological Mesh After Extralevator Abdominoperineal Resection for Rectal Cancer. Dis Colon Rectum. 2026 Sep 1;69(9):2312-2320. doi: 10.1097/DCR.0000000000004326. Epub 2026 Jun 15.
PubMed 42290606Musters GD, Bemelman WA, Bosker RJ, Burger JW, van Duijvendijk P, van Etten B, van Geloven AA, de Graaf EJ, Hoff C, de Korte N, Leijtens JW, Rutten HJ, Singh B, van de Ven A, Vuylsteke RJ, de Wilt JH, Dijkgraaf MG, Tanis PJ. Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study). BMC Surg. 2014 Aug 27;14:58. doi: 10.1186/1471-2482-14-58.
PubMed 25163547
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01927497
- Acronym / sponsor ID
- BIOPEX / METC 2012_360
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Extralevator abdominoperineal resection, Biological Mesh, Primary closure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- LifeCell
- Study start
- 8 Mar 2013 (actual)
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Posted 17 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data.
Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy.
Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh.
Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized.
Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm.
Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological mesh closure | Experimental | Procedure: Biological mesh assisted perineal closureBiological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection |
| Primary perineal closure | Active comparator | Procedure: Primary perineal closurePrimary perineal closure after extralevator abdomino perineal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 years or higher.
- Planned for eAPR for primary rectal cancer.
- Life expectancy of more than 2 years.
- Ability to return for all scheduled and required study visits.
- Preoperative (chemo)radiotherapy.
Key exclusion criteria (6 listed)
- Previous pelvic irradiation for other cancers (i.e. prostate cancer).
- Total exenteration or sacral resection above level S4/S5.
- Sensitivity to porcine derived products or polysorbate.
- Severe systemic diseases affecting wound healing (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV).
- Collagen disorders (i.e. Marfan).
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 |
|---|---|---|
| Biological mesh assisted perineal closureAlso: Biological Mesh, Strattice™, Strattice® Reconstructive Tissue Matrix, LifecellThe eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm. | Procedure or surgery | Biological mesh closure |
| Primary perineal closureAlso: Primary closure, Perineal wound closureThe perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon. | Procedure or surgery | Primary perineal closure |
Primary outcome
30-day Uncomplicated Perineal Wound Healing
Time frame: From operation to 30 days after the operation
uncomplicated perineal wound healing is defined as a Souphampton wound score less than II
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42290606van den Berg R, Musters GD, Verhoef C, Sharabiany S, Hompes R, Singh B, Chaudhri SS, van Geloven AAW, Vuylsteke RJCLM, de Wilt JHW, Leijtens JWA, Vermaas M, Rothbarth J, Burger JWA, Lamme B, van de Ven A, Blommestein HM, Tanis PJ. Cost-Effectiveness of Pelvic Floor Reconstruction Using Biological Mesh After Extralevator Abdominoperineal Resection for Rectal Cancer. Dis Colon Rectum. 2026 Sep 1;69(9):2312-2320. doi: 10.1097/DCR.0000000000004326. Epub 2026 Jun 15.
- Derived from this study: PubMed 25163547Musters GD, Bemelman WA, Bosker RJ, Burger JW, van Duijvendijk P, van Etten B, van Geloven AA, de Graaf EJ, Hoff C, de Korte N, Leijtens JW, Rutten HJ, Singh B, van de Ven A, Vuylsteke RJ, de Wilt JH, Dijkgraaf MG, Tanis PJ. Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study). BMC Surg. 2014 Aug 27;14:58. doi: 10.1186/1471-2482-14-58.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Gijsbert D. Musters, M.D. study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Willem A. Bemelman, Prof, PhD, M.D. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Harm J. Rutten, M.D. PhD principal investigator
Catharina Ziekenhuis Eindhoven
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 Biological mesh assisted perineal closure and Primary perineal closure in people with Rectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 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 17 Aug 2021. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
30-day Uncomplicated Perineal Wound Healing (time frame: From operation to 30 days after the operation). 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 NCT01927497, which also lists 2 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 Aug 2021.