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Trial record 1 of 1 for:    BIOPEX 2
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Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer (BIOPEX2)

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ClinicalTrials.gov Identifier: NCT04004650
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gijsbert Musters, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Wound Heal Abdominoperineal Resection Rectal Cancer Procedure: Gluteal turnover flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Primary closure
Primary perineal closure after extralevator abdomino perineal resection
Experimental: Gluteal turnover flap
Gluteal flap reconstruction of the pelvic floor after extralevator abdomino perineal resection
Procedure: Gluteal turnover flap
Link to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Perineal wound healing [ Time Frame: 14 days, 3 and 6 months postoperatively ]
    Southampton wound score

  2. Re-intervention or re-admission rate [ Time Frame: 1,3,6 months ]
    Need tor re-intervention or re-admission related to pre-sacral abscess or either perineal wound problems.

  3. Perineal hernia rate [ Time Frame: 1,3,6 months ]
    lncidence of symptomatic and asymptomatic perineal hernia

  4. Health-related quality of life [ Time Frame: 1,3,6 months ]
    questionnaires: The 5-level EQ-5D version (EQ-5D-5L)

  5. Quality of Life in cancer patients [ Time Frame: 1,3,6 months ]
    questionnaires: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (C30-QL2, CR29)

  6. Generic quality of Life [ Time Frame: 3,6 months ]
    questionnaires: Short Form Survey (SF36)

  7. Urogenital Distress [ Time Frame: 1,3,6 months ]
    questionnaires: Urogenital Distress Inventory (UDI-6)

  8. Incontinence scale [ Time Frame: 1,3,6 months ]
    questionnaires:Incontinence Impact Questionnaire short form (IIQ-7)

  9. Urogenital function [ Time Frame: 1,3,6 months ]
    questionnaires: international index of erectile function (IIEF)

  10. Female sexual distress [ Time Frame: 1,3,6 months ]
    questionnaires: Female sexual distress scale (FSDS-R)



Information from the National Library of Medicine

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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:

  • clinical diagnosis of primary rectal cancer or recurrent rectal cancer
  • scheduled for abdominalperineal resection
  • older then 18 years

Exclusion Criteria:

  • 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.

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): NCT04004650


Contacts
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Contact: Sarah Sharabiany, MD 0031653663288 s.sharabiany@amsterdamumc.nl
Contact: Gijsnert Musters, MD, PhD g.d.musters@amsterdamumc.nl

Locations
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Netherlands
Amsterdam UMC, location AMC Recruiting
Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105AZ
Contact: Sarah Sharabiany, MD    0031653663288    s.sharabiany@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Pieter Tanis, Prof. MD. Phd 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: Gijsbert Musters, MD PhD, reseach coordinator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04004650    
Other Study ID Numbers: NL65461.018.18
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Wounds and Injuries
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases