Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-30 @ 3:33 AM
Study NCT ID:
NCT04004650
Status:
UNKNOWN
Last Update Posted:
2019-07-02
First Post:
2019-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-01', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perineal wound healing rate 30 days', 'timeFrame': '30 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Perineal wound healing', 'timeFrame': '14 days, 3 and 6 months postoperatively', 'description': 'Southampton wound score'}, {'measure': 'Re-intervention or re-admission rate', 'timeFrame': '1,3,6 months', 'description': 'Need tor re-intervention or re-admission related to pre-sacral abscess or either perineal wound problems.'}, {'measure': 'Perineal hernia rate', 'timeFrame': '1,3,6 months', 'description': 'lncidence of symptomatic and asymptomatic perineal hernia'}, {'measure': 'Health-related quality of life', 'timeFrame': '1,3,6 months', 'description': 'questionnaires: The 5-level EQ-5D version (EQ-5D-5L)'}, {'measure': 'Quality of Life in cancer patients', 'timeFrame': '1,3,6 months', 'description': 'questionnaires: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (C30-QL2, CR29)'}, {'measure': 'Generic quality of Life', 'timeFrame': '3,6 months', 'description': 'questionnaires: Short Form Survey (SF36)'}, {'measure': 'Urogenital Distress', 'timeFrame': '1,3,6 months', 'description': 'questionnaires: Urogenital Distress Inventory (UDI-6)'}, {'measure': 'Incontinence scale', 'timeFrame': '1,3,6 months', 'description': 'questionnaires:Incontinence Impact Questionnaire short form (IIQ-7)'}, {'measure': 'Urogenital function', 'timeFrame': '1,3,6 months', 'description': 'questionnaires: international index of erectile function (IIEF)'}, {'measure': 'Female sexual distress', 'timeFrame': '1,3,6 months', 'description': 'questionnaires: Female sexual distress scale (FSDS-R)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Heal', 'Abdominoperineal Resection', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '39908025', 'type': 'DERIVED', 'citation': 'Kreisel 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.'}, {'pmid': '32703182', 'type': 'DERIVED', 'citation': 'Sharabiany 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.'}]}, 'descriptionModule': {'briefSummary': "Background:\n\nAbout 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.\n\nObjective:\n\nThe 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.\n\nA 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.\n\nStudy design:\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of primary rectal cancer or recurrent rectal cancer\n* scheduled for abdominalperineal resection\n* older then 18 years\n\nExclusion Criteria:\n\n* intersphincteric APR\n* (biological) mesh placement\n* extended resections (sacral resection except for coccyx resection, (posterior) exenteration)\n* 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)\n* enrolment in other trials with overlapping primary endpoint.'}, 'identificationModule': {'nctId': 'NCT04004650', 'acronym': 'BIOPEX2', 'briefTitle': 'Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer', 'orgStudyIdInfo': {'id': 'NL65461.018.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Primary closure', 'description': 'Primary perineal closure after extralevator abdomino perineal resection'}, {'type': 'EXPERIMENTAL', 'label': 'Gluteal turnover flap', 'description': 'Gluteal flap reconstruction of the pelvic floor after extralevator abdomino perineal resection', 'interventionNames': ['Procedure: Gluteal turnover flap']}], 'interventions': [{'name': 'Gluteal turnover flap', 'type': 'PROCEDURE', 'description': 'Link to procedure: https://www.youtube.com/watch?v=u7\\_vH2\\_1ZZc', 'armGroupLabels': ['Gluteal turnover flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam-Zuidoost', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sarah Sharabiany, MD', 'role': 'CONTACT', 'email': 's.sharabiany@amsterdamumc.nl', 'phone': '0031653663288'}], 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}], 'centralContacts': [{'name': 'Sarah Sharabiany, MD', 'role': 'CONTACT', 'email': 's.sharabiany@amsterdamumc.nl', 'phone': '0031653663288'}, {'name': 'Gijsnert Musters, MD, PhD', 'role': 'CONTACT', 'email': 'g.d.musters@amsterdamumc.nl'}], 'overallOfficials': [{'name': 'Pieter Tanis, Prof. MD. Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD, reseach coordinator', 'investigatorFullName': 'Gijsbert Musters', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}