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临床试验/NCT04004650
NCT04004650Unknown不适用

Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Perineal wound healing rate 30 days

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Primary closure

No Intervention

Primary perineal closure after extralevator abdomino perineal resection

Gluteal turnover flap

Experimental

Gluteal flap reconstruction of the pelvic floor after extralevator abdomino perineal resection

干预措施: Gluteal turnover flap (Procedure)

结局指标

主要结局

Perineal wound healing rate 30 days

时间窗: 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.

次要结局

  • Incontinence scale(1,3,6 months)
  • Perineal wound healing(14 days, 3 and 6 months postoperatively)
  • Re-intervention or re-admission rate(1,3,6 months)
  • Perineal hernia rate(1,3,6 months)
  • Health-related quality of life(1,3,6 months)
  • Quality of Life in cancer patients(1,3,6 months)
  • Generic quality of Life(3,6 months)
  • Urogenital Distress(1,3,6 months)
  • Female sexual distress(1,3,6 months)
  • Urogenital function(1,3,6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gijsbert Musters

MD PhD, reseach coordinator

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

研究点 (2)

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