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Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer (BIOPEX)

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ClinicalTrials.gov Identifier: NCT01927497
Recruitment Status : Unknown
Verified October 2017 by P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : August 22, 2013
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Biological mesh assisted perineal closure Procedure: Primary perineal closure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Results of Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer
Study Start Date : March 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biological mesh closure
Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection
Procedure: Biological mesh assisted perineal closure
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.
Other Names:
  • Biological Mesh
  • Strattice™
  • Strattice® Reconstructive Tissue Matrix
  • Lifecell
  • Porcine dermal Mesh

Active Comparator: Primary perineal closure
Primary perineal closure after extralevator abdomino perineal resection
Procedure: Primary perineal 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.
Other Names:
  • Primary closure
  • Perineal wound closure




Primary Outcome Measures :
  1. The primary endpoint is the percentage of uncomplicated perineal wound healing [ Time Frame: From operation to 30 days after the operation ]
    Souphampton wound score less than II


Secondary Outcome Measures :
  1. Perineal wound healing according to the Southampton wound grading [ Time Frame: From the operation to 3, 6, 9 and 12 months postoperative ]
  2. Incidence of persistent perineal or presacral sinuses, both clinically and by imaging [ Time Frame: From the operation to 7 days, 1,3,6,9 and 12 months postoperative ]
  3. Need for re-intervention or re-admission related to pre-sacral abscess or other perineal wound problems [ Time Frame: From operation to 1,3,6, 9 and 12 months postoperative ]
  4. Length of hospital stay [ Time Frame: From date of operation until the date of discharge or date of death up to 12 months ]
  5. Need for nursing home admission [ Time Frame: From the operation up to 12 months postoperative ]
  6. Need for home nursing wound care: frequency per week and total period of time [ Time Frame: Will be followed for the duration of perineal wound problems up to 12 months postoperative ]
  7. Use of wound care material and devices like vacuum assisted closure [ Time Frame: Will be followed for the duration of perineal wound problems up to 12 months postoperative ]
  8. Incidence of symptomatic and asymptomatic perineal hernia [ Time Frame: From operation to 1, 3, 6, 9 and 12 months of follow-up postoperative ]
  9. Quality of life [ Time Frame: From opertion to 1, 3,6,9 and 12 months of follow-up postoperative ]
    Questionaire: EQ-5D, EORTC-30, EORTC-29RC

  10. Costs [ Time Frame: From the operation up till 12 months postoperative ]
    Health and labour questionaire and wound diary (if applicable)


Other Outcome Measures:
  1. Long term (5-year) perineal wound related problems and functional outcome [ Time Frame: Until 5-years postoperatively ]
    Following publication of the primary and secondary outcomes at 1-year, it has been decided to extend the follow-up to 5-year for the purpose of determining long-term perineal morbidity (chronic perineal sinus, perineal hernia) and functional outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18 years or higher.
  2. Planned for eAPR for primary rectal cancer.
  3. Life expectancy of more than 2 years.
  4. Ability to return for all scheduled and required study visits.
  5. Preoperative (chemo)radiotherapy.
  6. Written informed consent for study participation.

Exclusion Criteria:

  1. Previous pelvic irradiation for other cancers (i.e. prostate cancer).
  2. Total exenteration or sacral resection above level S4/S5.
  3. Sensitivity to porcine derived products or polysorbate.
  4. Severe systemic diseases affecting wound healing (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV).
  5. Collagen disorders (i.e. Marfan).
  6. Enrolment in trials with overlapping primary endpoint or otherwise expected influence on wound healing (i.e. biological therapy like antiangiogenic agents).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927497


Contacts
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Contact: Robin D Blok, M.D. +31-20-5669111 r.d.blok@amc.nl
Contact: Pieter J. Tanis, PhD, M.D. +31-20-5662971 ext 62660 p.j.tanis@amc.nl

Locations
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Netherlands
Academic Medical Cener Recruiting
Amsterdam, Noord-holland, Netherlands, 1105AZ
Contact: Robert D Blok, M.D.    +31-205669111    r.d.blok@amc.nl   
Contact: Pieter J Tanis, M.D. PhD    +31-205669111 ext 66260    P.J.Tanis@amc.nl   
Principal Investigator: Pieter J Tanis, phD, M.D.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
LifeCell
Investigators
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Study Chair: Gijsbert D. Musters, M.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: 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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: P.J. Tanis, dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01927497     History of Changes
Other Study ID Numbers: METC 2012_360
NTR3717 ( Other Identifier: Nederlands Trial register )
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Keywords provided by P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Rectal cancer
Extralevator abdominoperineal resection
Biological Mesh
Primary closure
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases