Rectal CancerNEAPENCT01347697
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
A study testing Reconstruction with an acellular porcine dermal collagen implant (biological mesh) and Reconstruction with a gluteus maximus myocutaneous flap in people with Rectal Cancer and Defect of Floor of Lesser Pelvis, run by Umeå University at 8 sites in 2 countries.
Trial summary
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: a technique using a gluteus maximus myocutaneous flap or a technique using an acellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Defect of Floor of Lesser Pelvis
- What is being tested?
- Reconstruction with an acellular porcine dermal collagen implant (biological mesh) and Reconstruction with a gluteus maximus myocutaneous flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Sep 2011to 30 Sep 2024
- 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
- Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.
Who cannot join
- Age less than 18 years
- Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction
- Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option
- Expected survival less than one year at operation
- Patient do not sign informed consent document
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Sweden7 sites
Sunderby County Hospital
Luleå, 971 80
Skåne Universtiy Hospital
Malmö, 20502
Östersund Hospital
Östersund, 831 83
Karolinska University Hospital, Solna
Stockholm, 171 76
Umeå University Hospital, Department of Surgical and Perioperative Sciences
Umeå, 901 85
Uppsala University Hospital
Uppsala, 751 85
Västmanlands Sjukhus Västerås
Västerås, 72189
About this study
Official title: Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:
- a technique using a gluteus maximus myocutaneous flap or
- a technique using an acellular porcine collagen implant (biological mesh)
Read more
The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.
The study is interventional, randomized and by definition a comparative effectiveness research project.
Read the detailed description
Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative operation for rectal carcinomas too low for primary anastomosis, especially if the levator and sphincter musculature is infiltrated. This enlarged operation, when the levator musculature is excised en bloc with the rectum, creates a large defect. Primary closure is often not possible, and reconstruction with prosthetic material or a myocutaneous flap is necessary to avoid a perineal hernia. Implantation of a collagen sheet (biological mesh) has shown preliminary good results and on the other hand, the use of a gluteus myocutaneous flap is routine in many clinics. There is a lack of scientific evidence to prove which method is better for the reconstruction of the lesser pelvic floor.
The current study aims to compare the two reconstruction techniques.
Centres that treat locally advanced rectal cancers with the extended abdominoperineal excision of rectum (EAPE)[Holm et al 2007] can participate provided that:
- the operative technique is standardized according to the study protocol
- the centre/unit has resources for examinations of participants by a physiotherapist or a nurse
- the centre/unit has one investigator in charge of the study locally
- the centre/unit has an operative volume that enables at least 6 patients to be included/randomised during the anticipated three year study phase for inclusions
Centres that do not operate the rectal cancers included in this study can participate by arranging the preoperative examination and physical tests as well as follow-up of patients that are referred to other centres for the operation. In these cases the operating centre cares for the randomisation, operation and start of postoperative rehabilitation while the study follow-up and final rehabilitation can be completed at the patients' primary referral hospital. The primary referral hospital needs a site investigator in charge of study patients just like centres that do the operations.
Patients with primary or recurrent cancers of rectal origin can be included but individual patients can be included only once. Concomitant therapies are allowed and preoperative or postoperative radiation therapy and/or chemotherapy may be given or not according to local multidisciplinary team (MDT) decisions.
- Conditions
- Rectal Cancer, Defect of Floor of Lesser Pelvis
- Being tested
- Reconstruction with an acellular porcine dermal collagen implant (biological mesh), Reconstruction with a gluteus maximus myocutaneous flap
- Keywords
- rectal neoplasms, reconstructive surgical procedure, bioprosthesis, surgical flaps, locomotion, lesser pelvis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction with an acellular porcine dermal collagen implant (biological mesh)Procedure or surgery
Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer.
Reconstruction with a gluteus maximus myocutaneous flapProcedure or surgery
Reconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low rectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Porcine collagen implant (biological mesh) | Experimental | Reconstruction with an acellular porcine dermal collagen implant (biological mesh). Receives: Procedure: Reconstruction with an acellular porcine dermal collagen implant (biological mesh) |
| Gluteus maximus flap | Active comparator | Reconstruction with a gluteus maximus myocutaneous flap. Receives: Procedure: Reconstruction with a gluteus maximus myocutaneous flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in Timed-Stands Test
Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.
Measured: 6 months after surgery
Secondary outcomes (13)
Change in physical performance
Change in Timed-Stands Test performance
Measured: 3, 6 and 12 months after surgery compared with preoperative results
Primary wound healing assessed with the Southampton Wound Assessment Scale
The Southampton Wound Assessment Scale is a validated measure of wound healing after surgery.
Measured: 3 months from operation
Complications according to classification by Dindo-Clavien
The Dindo-Clavien classification of surgical complications is a validated instrument.
Measured: 3, 6 and 12 months after surgery
Proportion of persistent perineal sinus or fistula
Proportion of patients with the wound healing defect of all patients in the particular study arm
Measured: 3, 6 and 12 months after surgery
Ability to sit
Ability to sit is graded with a scale in three degrees.
Measured: 3, 6 and 12 months after surgery
Change of pain and discomfort in gluteal region measured with VAS
A standard visual analogue scale (VAS) from 0-100 mm is used.
Measured: 3, 6 and 12 months after surgery compared to preoperative
Pain and discomfort in gluteal region, spot measures with VAS
A standard visual analogue scale (VAS) from 0-100 mm is used.
Measured: 3, 6 and 12 months after surgery
Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29
EQ-5D and EORTC are validated quality of life instruments
Measured: 3, 6 and 12 months after surgery compared to preoperative
Quality of life spot measures
Quality of life at specified time points
Measured: 3, 6 and 12 months after surgery
Length of hospital stay
Length of index hospital stay in days.
Measured: Six months after surgery
Costs of surgical treatment
Hospital expenses converted to US$
Measured: 12 months after surgery
Quality-adjusted life years (QALYs gained)
Quality adjusted life year (QALY) is calculated using an quality of life utility index at repeated time points. The utility index is adjusted for the relevant background population.
Measured: 12 months after surgery
Local recurrence
Local recurrence of rectal cancer detected by clinical or radiological investigation
Measured: Five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study start5 Sep 2011
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Umeå UniversityThe 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
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Society of Medicine, Västerbotten County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Markku M Haapamäki, MD, PhD, Principal investigator, Umeå University, Department of Surgical and Perioperative SciencesJörgen Rutegård, MD, PhD, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347697
- Sponsor's protocol ID
- NEAPE-2010-335-31M
- Acronym
- NEAPE
- Status last verified
- Sep 2025
- First submitted
- 3 May 2011
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489.
PubMed 17143848Haapamaki MM, Pihlgren V, Lundberg O, Sandzen B, Rutegard J. Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap. Dis Colon Rectum. 2011 Jan;54(1):101-6. doi: 10.1007/DCR.0b013e3181fce26e.
PubMed 21160320Rutegard M, Svensson J, Rutegard J, Rautio T, Nilsson PJ, Sjostrom O, Lydrup ML, Odensten C, Soderstrom A, Dahlberg M, Haapamaki MM. Collagen implant versus gluteus maximus flap for perineal closure after extended abdominoperineal excision: NEAPE randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag079. doi: 10.1093/bjsopen/zrag079.
PubMed 42341212Rutegard M, Rutegard J, Haapamaki MM. Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study. BMJ Open. 2019 May 29;9(5):e027255. doi: 10.1136/bmjopen-2018-027255.
PubMed 31147361
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
- ClinicalTrials.gov ID
- NCT01347697
- Acronym / sponsor ID
- NEAPE / NEAPE-2010-335-31M
- Conditions
- Rectal Cancer, Defect of Floor of Lesser Pelvis
- Keywords
- rectal neoplasms, reconstructive surgical procedure, bioprosthesis, surgical flaps, locomotion, lesser pelvis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- The Swedish Society of Medicine, Västerbotten County Council, Sweden
- Study start
- 5 Sep 2011 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:
- a technique using a gluteus maximus myocutaneous flap or
- a technique using an acellular porcine collagen implant (biological mesh)
The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.
The study is interventional, randomized and by definition a comparative effectiveness research project.
Detailed description
Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative operation for rectal carcinomas too low for primary anastomosis, especially if the levator and sphincter musculature is infiltrated. This enlarged operation, when the levator musculature is excised en bloc with the rectum, creates a large defect. Primary closure is often not possible, and reconstruction with prosthetic material or a myocutaneous flap is necessary to avoid a perineal hernia. Implantation of a collagen sheet (biological mesh) has shown preliminary good results and on the other hand, the use of a gluteus myocutaneous flap is routine in many clinics. There is a lack of scientific evidence to prove which method is better for the reconstruction of the lesser pelvic floor.
The current study aims to compare the two reconstruction techniques.
Centres that treat locally advanced rectal cancers with the extended abdominoperineal excision of rectum (EAPE)[Holm et al 2007] can participate provided that:
- the operative technique is standardized according to the study protocol
- the centre/unit has resources for examinations of participants by a physiotherapist or a nurse
- the centre/unit has one investigator in charge of the study locally
- the centre/unit has an operative volume that enables at least 6 patients to be included/randomised during the anticipated three year study phase for inclusions
Centres that do not operate the rectal cancers included in this study can participate by arranging the preoperative examination and physical tests as well as follow-up of patients that are referred to other centres for the operation. In these cases the operating centre cares for the randomisation, operation and start of postoperative rehabilitation while the study follow-up and final rehabilitation can be completed at the patients' primary referral hospital. The primary referral hospital needs a site investigator in charge of study patients just like centres that do the operations.
Patients with primary or recurrent cancers of rectal origin can be included but individual patients can be included only once. Concomitant therapies are allowed and preoperative or postoperative radiation therapy and/or chemotherapy may be given or not according to local multidisciplinary team (MDT) decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porcine collagen implant (biological mesh) | Experimental | Procedure: Reconstruction with an acellular porcine dermal collagen implant (biological mesh)Reconstruction with an acellular porcine dermal collagen implant (biological mesh). |
| Gluteus maximus flap | Active comparator | Procedure: Reconstruction with a gluteus maximus myocutaneous flapReconstruction with a gluteus maximus myocutaneous flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.
Key exclusion criteria (5 listed)
- Age less than 18 years
- Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction
- Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option
- Expected survival less than one year at operation
- Patient do not sign informed consent document
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 |
|---|---|---|
| Reconstruction with an acellular porcine dermal collagen implant (biological mesh)Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer. | Procedure or surgery | Porcine collagen implant (biological mesh) |
| Reconstruction with a gluteus maximus myocutaneous flapReconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low rectal cancer. | Procedure or surgery | Gluteus maximus flap |
Primary outcome
Performance in Timed-Stands Test
Time frame: 6 months after surgery
Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.
13 secondary outcomes
Change in physical performance
Time frame: 3, 6 and 12 months after surgery compared with preoperative results
Primary wound healing assessed with the Southampton Wound Assessment Scale
Time frame: 3 months from operation
Complications according to classification by Dindo-Clavien
Time frame: 3, 6 and 12 months after surgery
Proportion of persistent perineal sinus or fistula
Time frame: 3, 6 and 12 months after surgery
Ability to sit
Time frame: 3, 6 and 12 months after surgery
Change of pain and discomfort in gluteal region measured with VAS
Time frame: 3, 6 and 12 months after surgery compared to preoperative
Pain and discomfort in gluteal region, spot measures with VAS
Time frame: 3, 6 and 12 months after surgery
Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29
Time frame: 3, 6 and 12 months after surgery compared to preoperative
Quality of life spot measures
Time frame: 3, 6 and 12 months after surgery
Length of hospital stay
Time frame: Six months after surgery
Costs of surgical treatment
Time frame: 12 months after surgery
Quality-adjusted life years (QALYs gained)
Time frame: 12 months after surgery
Local recurrence
Time frame: Five years after surgery
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 3 Oct 2025.
- Background: PubMed 17143848Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489.
- Background: PubMed 21160320Haapamaki MM, Pihlgren V, Lundberg O, Sandzen B, Rutegard J. Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap. Dis Colon Rectum. 2011 Jan;54(1):101-6. doi: 10.1007/DCR.0b013e3181fce26e.
- Derived from this study: PubMed 42341212Rutegard M, Svensson J, Rutegard J, Rautio T, Nilsson PJ, Sjostrom O, Lydrup ML, Odensten C, Soderstrom A, Dahlberg M, Haapamaki MM. Collagen implant versus gluteus maximus flap for perineal closure after extended abdominoperineal excision: NEAPE randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag079. doi: 10.1093/bjsopen/zrag079.
- Derived from this study: PubMed 31147361Rutegard M, Rutegard J, Haapamaki MM. Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study. BMJ Open. 2019 May 29;9(5):e027255. doi: 10.1136/bmjopen-2018-027255.
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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.
Markku M Haapamäki, MD, PhD principal investigator
Umeå University, Department of Surgical and Perioperative Sciences
Jörgen Rutegård, MD, PhD study director
Umeå University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction with an acellular porcine dermal collagen implant (biological mesh) and Reconstruction with a gluteus maximus myocutaneous flap in people with Rectal Cancer and Defect of Floor of Lesser Pelvis, run by Umeå University at 8 sites in 2 countries.
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 1 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in Timed-Stands Test (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347697, which also lists 4 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 3 Oct 2025.