NCT01927497

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
6 years until next milestone

Results Posted

Study results publicly available

August 17, 2021

Completed
Last Updated

August 17, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

August 19, 2013

Results QC Date

July 13, 2019

Last Update Submit

July 23, 2021

Conditions

Rectal Cancer

Keywords

Rectal cancerExtralevator abdominoperineal resectionBiological MeshPrimary closure

Outcome Measures

Primary Outcomes (1)

  • 30-day Uncomplicated Perineal Wound Healing

    uncomplicated perineal wound healing is defined as a Souphampton wound score less than II

    From operation to 30 days after the operation

Study Arms (2)

Biological mesh closure

EXPERIMENTAL

Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection

Procedure: Biological mesh assisted perineal closure

Primary perineal closure

ACTIVE COMPARATOR

Primary perineal closure after extralevator abdomino perineal resection

Procedure: Primary perineal closure

Interventions

Biological mesh assisted perineal closurePROCEDURE

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.

Also known as: Biological Mesh, Strattice™, Strattice® Reconstructive Tissue Matrix, Lifecell, Porcine dermal Mesh
Biological mesh closure
Primary perineal closurePROCEDURE

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.

Also known as: Primary closure, Perineal wound closure
Primary perineal closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Cener

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • Musters 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.

    PMID: 25163547DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

strattice

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
prof. dr. P.J. Tanis
Organization
Academic medical center
g.d.musters@amc.nl
0031205669111

Study Officials

  • Gijsbert D. Musters, M.D.

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY CHAIR

  • Willem A. Bemelman, Prof, PhD, M.D.

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

  • Harm J. Rutten, M.D. PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Baljit Singh, M.D. PhD

    Leicester hospital, Leicester

    PRINCIPAL INVESTIGATOR

  • Marcel G.W. Dijkgraaf, M.D.

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 22, 2013

Study Start

March 8, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

August 17, 2021

Results First Posted

August 17, 2021

Record last verified: 2021-07

Locations

NL(1)