Wound HealBIOPEX2NCT04004650
Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer
A study testing Gluteal turnover flap in people with Wound Heal and Abdominoperineal Resection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Background: About 700 patients per year undergo an abdominoperineal resection (APR) for distal rectal cancer (Dutch Colorectal Audit 2016).Neoadjuvant (chemo)radiotherapy is often used to further improve locoregional control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Abdominoperineal Resection, Rectal Cancer
- What is being tested?
- Gluteal turnover flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jun 2019to 1 Nov 2022
- 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
- clinical diagnosis of primary rectal cancer or recurrent rectal cancer
- scheduled for abdominalperineal resection
- older then 18 years
Who cannot join
- intersphincteric APR
- (biological) mesh placement
- extended resections (sacral resection except for coccyx resection, (posterior) exenteration)
- severe systemic diseases affecting wound healing except diabetes (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV), collagen disorders (i.e. Marfan)
- enrolment in other trials with overlapping primary endpoint.
Trial locations and contacts
1 site in 1 country.
Gijsnert Musters, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam-Zuidoost, North Holland, 1105AZ
Sarah Sharabiany, MD, 0031653663288, s.sharabiany@amsterdamumc.nl
About this study
Background:
About 700 patients per year undergo an abdominoperineal resection (APR) for distal rectal cancer (Dutch Colorectal Audit 2016).Neoadjuvant (chemo)radiotherapy is often used to further improve locoregional control. Morbidity after APR is substantial and mainly consisting of perineal wound problems in about 35% of the patients. lf primary healing of the perineal wound after APR doesn't occur, secondary healing can take up to one year, and there is even a small proportion of patients in whom a chronic perineal wound or fistula persists after one year. During this long period, intensive wound care is necessary. This results in a heavy burden on both patient and health care resources.
Read more
Objective:
The high morbidity rate of the perineal wound has resulted in a continuing discussion on how to close the perineal defect after APR. Our research group recently published the BIOPEX-study (NL42094.018.12), in which 104 patients were randomized between primary perinea! wound closure and biological mesh closure of the pelvic floor after APR with preoperative radiotherapy for rectal cancer. Similar uncomplicated perineal wound healing rate at 30 days (Southampton wound score < 2) was found: 63% versus 66%, respectively. The hypothesis behind this negative trial result is related to the perineal dead space between the skin and the biological mesh. Fluid will accumulate in this dead space with the risk of secondary contamination and abscess formation, leading to wound dehiscence and purulent discharge. Autologous tissue flaps have been suggested to improve perineal wound healing based on several cohort studies. At least in the Netherlands, these flaps are used only for selected patients with the large defects and highest risk of wound problems, because of the more extensive surgery with added surgical trauma and operative time, and associated donor site morbidity. For these reasons, primary perineal closure (control arm of BIOPEX) is still the standard of care in the Netherlands.
A gluteal turnover flap (GT flap) is a small transposition flap trom the unilateral adjacent perineal skin and subcutaneous fat, which is flipped into the perineal dead space, and stitched with the de-epithelialised dermis to the contralateral pelvic floor remnant. Subsequently, the perineal subcutaneous fat and skin are closed over the flap in the midline, thereby not adding a donor site scar. A small pilot study trom our group showed that this is a promising solution for routine perineal closure after APR.
Study design:
In this multicenter single blinded study, eligible patients will be randomized between pelvic floor reconstruction using a GT flap (intervention arm) and primary closure of the perineal defect (standard arm). The perineal wound healing will be evaluated at 14 days and 1, 3, and 6 months post-operatively using the Southampton wound scoring system by an independent observer.
- Conditions
- Wound Heal, Abdominoperineal Resection, Rectal Cancer
- Being tested
- Gluteal turnover flap
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluteal turnover flapProcedure or surgery
Link to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc
| Study group | Role | What they receive |
|---|---|---|
| Primary closure | No intervention | Primary perineal closure after extralevator abdomino perineal resection |
| Gluteal turnover flap | Experimental | Gluteal flap reconstruction of the pelvic floor after extralevator abdomino perineal resection Receives: Procedure: Gluteal turnover flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal wound healing rate 30 days
The primary endpoint of the study is the percentage of uncomplicated perineal wound healing defined as a Southampton wound score of less than Il at 30 days postoperatively.
Measured: 30 days
Secondary outcomes (10)
Perineal wound healing
Southampton wound score
Measured: 14 days, 3 and 6 months postoperatively
Re-intervention or re-admission rate
Need tor re-intervention or re-admission related to pre-sacral abscess or either perineal wound problems.
Measured: 1,3,6 months
Perineal hernia rate
lncidence of symptomatic and asymptomatic perineal hernia
Measured: 1,3,6 months
Health-related quality of life
questionnaires: The 5-level EQ-5D version (EQ-5D-5L)
Measured: 1,3,6 months
Quality of Life in cancer patients
questionnaires: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (C30-QL2, CR29)
Measured: 1,3,6 months
Generic quality of Life
questionnaires: Short Form Survey (SF36)
Measured: 3,6 months
Urogenital Distress
questionnaires: Urogenital Distress Inventory (UDI-6)
Measured: 1,3,6 months
Incontinence scale
questionnaires:Incontinence Impact Questionnaire short form (IIQ-7)
Measured: 1,3,6 months
Urogenital function
questionnaires: international index of erectile function (IIEF)
Measured: 1,3,6 months
Female sexual distress
questionnaires: Female sexual distress scale (FSDS-R)
Measured: 1,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start28 Jun 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
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 Wound HealStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gijsbert Musters, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Pieter Tanis, Prof. MD. Phd, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004650
- Sponsor's protocol ID
- NL65461.018.18
- Acronym
- BIOPEX2
- Status last verified
- Jul 2019
- First submitted
- 10 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Berg R, Musters GD, Verhoef C, Blommestein HM, Tanis PJ; BIOPEX-2 Study Group. Cost-effectiveness of the gluteal turnover flap for perineal wound closure after abdominoperineal resection: randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag059. doi: 10.1093/bjsopen/zrag059.
PubMed 42308016Kreisel SI, Sharabiany S, Tuynman J, Belgers EHJ, Singh B, Chaudhri S, van Geloven AAW, Vuylsteke RJCLM, de Wilt JHW, Melenhorst J, Leijtens JWA, Vermaas M, Rothbarth J, Verhoef C, Burger JWA, Polat F, Fabry HFJ, Aalbers AGJ, Wijsman JH, Lamme B, van der Bilt JDW, Lapid O, van Dieren S, Hompes R, Tanis PJ, Musters GD. Perineal Wound Closure Using Gluteal Turnover Flap After Abdominoperineal Resection for Rectal Cancer: The BIOPEX-2 Randomized Clinical Trial. JAMA Surg. 2025 Apr 1;160(4):378-385. doi: 10.1001/jamasurg.2024.6818.
PubMed 39908025Sharabiany S, Blok RD, Lapid O, Hompes R, Bemelman WA, Alberts VP, Lamme B, Wijsman JH, Tuynman JB, Aalbers AGJ, Beets GL, Fabry HFJ, Cherepanin IM, Polat F, Burger JWA, Rutten HJT, Bosker RJI, Talsma K, Rothbarth J, Verhoef C, van de Ven AWH, van der Bilt JDW, de Graaf EJR, Doornebosch PG, Leijtens JWA, Heemskerk J, Singh B, Chaudhri S, Gerhards MF, Karsten TM, de Wilt JHW, Bremers AJA, Vuylsteke RJCLM, Heuff G, van Geloven AAW, Tanis PJ, Musters GD. Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study). BMC Surg. 2020 Jul 23;20(1):164. doi: 10.1186/s12893-020-00823-7.
PubMed 32703182
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04004650
- Acronym / sponsor ID
- BIOPEX2 / NL65461.018.18
- Conditions
- Wound Heal, Abdominoperineal Resection, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 2 Jul 2019 (actual)
- 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.
Background:
About 700 patients per year undergo an abdominoperineal resection (APR) for distal rectal cancer (Dutch Colorectal Audit 2016).Neoadjuvant (chemo)radiotherapy is often used to further improve locoregional control. Morbidity after APR is substantial and mainly consisting of perineal wound problems in about 35% of the patients. lf primary healing of the perineal wound after APR doesn't occur, secondary healing can take up to one year, and there is even a small proportion of patients in whom a chronic perineal wound or fistula persists after one year. During this long period, intensive wound care is necessary. This results in a heavy burden on both patient and health care resources.
Objective:
The high morbidity rate of the perineal wound has resulted in a continuing discussion on how to close the perineal defect after APR. Our research group recently published the BIOPEX-study (NL42094.018.12), in which 104 patients were randomized between primary perinea! wound closure and biological mesh closure of the pelvic floor after APR with preoperative radiotherapy for rectal cancer. Similar uncomplicated perineal wound healing rate at 30 days (Southampton wound score < 2) was found: 63% versus 66%, respectively. The hypothesis behind this negative trial result is related to the perineal dead space between the skin and the biological mesh. Fluid will accumulate in this dead space with the risk of secondary contamination and abscess formation, leading to wound dehiscence and purulent discharge. Autologous tissue flaps have been suggested to improve perineal wound healing based on several cohort studies. At least in the Netherlands, these flaps are used only for selected patients with the large defects and highest risk of wound problems, because of the more extensive surgery with added surgical trauma and operative time, and associated donor site morbidity. For these reasons, primary perineal closure (control arm of BIOPEX) is still the standard of care in the Netherlands.
A gluteal turnover flap (GT flap) is a small transposition flap trom the unilateral adjacent perineal skin and subcutaneous fat, which is flipped into the perineal dead space, and stitched with the de-epithelialised dermis to the contralateral pelvic floor remnant. Subsequently, the perineal subcutaneous fat and skin are closed over the flap in the midline, thereby not adding a donor site scar. A small pilot study trom our group showed that this is a promising solution for routine perineal closure after APR.
Study design:
In this multicenter single blinded study, eligible patients will be randomized between pelvic floor reconstruction using a GT flap (intervention arm) and primary closure of the perineal defect (standard arm). The perineal wound healing will be evaluated at 14 days and 1, 3, and 6 months post-operatively using the Southampton wound scoring system by an independent observer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary closure | No intervention | –Primary perineal closure after extralevator abdomino perineal resection |
| Gluteal turnover flap | Experimental | Procedure: Gluteal turnover flapGluteal flap reconstruction of the pelvic floor 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 (3 listed)
- clinical diagnosis of primary rectal cancer or recurrent rectal cancer
- scheduled for abdominalperineal resection
- older then 18 years
Key exclusion criteria (5 listed)
- intersphincteric APR
- (biological) mesh placement
- extended resections (sacral resection except for coccyx resection, (posterior) exenteration)
- severe systemic diseases affecting wound healing except diabetes (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV), collagen disorders (i.e. Marfan)
- enrolment in other trials with overlapping primary endpoint.
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 |
|---|---|---|
| Gluteal turnover flapLink to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc | Procedure or surgery | Gluteal turnover flap |
Primary outcome
Perineal wound healing rate 30 days
Time frame: 30 days
The primary endpoint of the study is the percentage of uncomplicated perineal wound healing defined as a Southampton wound score of less than Il at 30 days postoperatively.
10 secondary outcomes
Perineal wound healing
Time frame: 14 days, 3 and 6 months postoperatively
Re-intervention or re-admission rate
Time frame: 1,3,6 months
Perineal hernia rate
Time frame: 1,3,6 months
Health-related quality of life
Time frame: 1,3,6 months
Quality of Life in cancer patients
Time frame: 1,3,6 months
Generic quality of Life
Time frame: 3,6 months
Urogenital Distress
Time frame: 1,3,6 months
Incontinence scale
Time frame: 1,3,6 months
Urogenital function
Time frame: 1,3,6 months
Female sexual distress
Time frame: 1,3,6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Derived from this study: PubMed 42308016van den Berg R, Musters GD, Verhoef C, Blommestein HM, Tanis PJ; BIOPEX-2 Study Group. Cost-effectiveness of the gluteal turnover flap for perineal wound closure after abdominoperineal resection: randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag059. doi: 10.1093/bjsopen/zrag059.
- Derived from this study: PubMed 39908025Kreisel SI, Sharabiany S, Tuynman J, Belgers EHJ, Singh B, Chaudhri S, van Geloven AAW, Vuylsteke RJCLM, de Wilt JHW, Melenhorst J, Leijtens JWA, Vermaas M, Rothbarth J, Verhoef C, Burger JWA, Polat F, Fabry HFJ, Aalbers AGJ, Wijsman JH, Lamme B, van der Bilt JDW, Lapid O, van Dieren S, Hompes R, Tanis PJ, Musters GD. Perineal Wound Closure Using Gluteal Turnover Flap After Abdominoperineal Resection for Rectal Cancer: The BIOPEX-2 Randomized Clinical Trial. JAMA Surg. 2025 Apr 1;160(4):378-385. doi: 10.1001/jamasurg.2024.6818.
- Derived from this study: PubMed 32703182Sharabiany S, Blok RD, Lapid O, Hompes R, Bemelman WA, Alberts VP, Lamme B, Wijsman JH, Tuynman JB, Aalbers AGJ, Beets GL, Fabry HFJ, Cherepanin IM, Polat F, Burger JWA, Rutten HJT, Bosker RJI, Talsma K, Rothbarth J, Verhoef C, van de Ven AWH, van der Bilt JDW, de Graaf EJR, Doornebosch PG, Leijtens JWA, Heemskerk J, Singh B, Chaudhri S, Gerhards MF, Karsten TM, de Wilt JHW, Bremers AJA, Vuylsteke RJCLM, Heuff G, van Geloven AAW, Tanis PJ, Musters GD. Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study). BMC Surg. 2020 Jul 23;20(1):164. doi: 10.1186/s12893-020-00823-7.
- Individual participant dataSharing planned: No
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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.
Gijsnert Musters, MD, PhD contact
Pieter Tanis, Prof. MD. Phd principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluteal turnover flap in people with Wound Heal and Abdominoperineal Resection, 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 3 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 2 Jul 2019. 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.
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 Sarah Sharabiany, MD (0031653663288, s.sharabiany@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal wound healing rate 30 days (time frame: 30 days). 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 NCT04004650, 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 2 Jul 2019.