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临床试验/NCT06015360
NCT06015360尚未招募不适用

Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study

Royal Marsden NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
8
试验地点
2
主要终点
Number of patients with reduced scarring on vaginal biopsies

研究概览

简要总结

The GRASS study looks at performing a technique called "Fat Tissue Grafting" to assess whether it can reduce the side effects of vaginal stenosis effects and improve the sexual function of participants who wish to preserve penetrative sexual function

详细描述

Vaginal stenosis is a common sequelae of radiotherapy treatment for cervical cancer. This can cause significant sexual problems resulting in sexual avoidance, relationship problems, feelings of low self-esteem, isolation, and difficulties initiating new relationships. Vaginal changes resulting in narrowing (stenosis) and adhesions can also lead to painful vaginal examinations which are routinely performed during follow-up consultations.

The available treatments for vaginal problems include regular use of vaginal dilators, lubricants, and moisturisers, all of which have shown poor results despite requiring an incessant effort by women.

A technique called 'fat grafting' has been successfully and safely used for many years to rectify the cosmetic and functional consequences of Breast and Head and Neck Cancers treatments. This technique is performed under general anaesthesia and uses fat tissue that is removed from other parts of the body; usually thighs, abdomen, and buttocks, by liposuction. The fat tissue is then processed into liquid and injected into the required area to generate more elasticity and improve tissue quality. To our knowledge this technique has never been applied to the field of Gynaecology-oncology.

In 2021 this technique was used in one patient with severe vaginal stenosis after radiotherapy treatment for advanced cervical cancer, by the Gynaecological and Plastic surgical teams at the Royal Marsden Hospital (RM). The fat tissue was harvested and processed using the method as described and injected into the vagina area (rectovaginal wall) with the aim being to generate more elasticity and improve the quality of the vaginal tissue. As a result of the procedure, the patient now reports reduction in vaginal bleeding and pain experienced, and a noticeable improvement in the size of the vagina allowing for penetrative sex.

This innovative technique addresses a neglected and unmet need of women to manage a consequence of curative treatment that is underreported and often unrecognised. It also serves as an example of how cross-discipline work focused on real patients' needs can produce ground-breaking solutions to complex clinical conundrums, by mobilising highly specialist clinical experts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with cervical cancer
  • At least 2 years since finishing pelvic radiotherapy for gynaecological cancer
  • Treated at RM
  • Persistent symptoms of vaginal stenosis despite prior use of vaginal dilators/ oestrogen replacement / lubricants/moisturisers
  • Desiring vaginal intercourse

排除标准

  • Evidence of recurrent disease documented on Magnetic Resonance Imaging (MRI)
  • Patients unwilling / unable to provide written informed consent for the study

结局指标

主要结局

Number of patients with reduced scarring on vaginal biopsies

时间窗: 10 months

Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)

Improvement in sexual wellbeing

时间窗: 11 months

Measured using the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) questionnaire (11) - a score drop below 9 (a score of 9 or above represents significant sexual difficulties)

Improvement in cervical cancer specific quality of life

时间窗: 11 months

Cervical cancer specific quality of life measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-CX24 - 10% improvement of the scale range for MCID (minimally clinically important differences)

Number of patients able to have vaginal penetration without pain (yes / no)

时间窗: 11 months

Ability to have vaginal penetration , this is descriptive and will be provided as a yes / no answer by the patient at their follow up visit

Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging

时间窗: 10 months

Increase in the volume of the rectovaginal septum on pelvic MRI imaging

Improvement in overall quality of life

时间窗: 11 months

Overall quality of life measured using the EORTC QLQ-C30. Any improvement in overall score will be deemed as an improvement

次要结局

  • Retention(12 months)
  • Occurrence of Calvien Dindo complications(11 months)
  • Determination of patient acceptability of the research procedure and of the trial(11 months)
  • Recruitment(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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