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临床试验/NCT07632196
NCT07632196招募中不适用

Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia

Althaia Xarxa Assistencial Universitària de Manresa2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年2月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
2

研究概览

简要总结

Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes.

The aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia.

It will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • - Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME).

排除标准

  • Patients not operated or within active surveillance strategy programs (watch & wait)
  • Patients with ostomy
  • Patients with contraindications to the use of the neurostimulator:
  • Pacemaker / Defibrillator / Other electronic devices
  • History of heart problems
  • Propensity to excessive bleeding (coagulopathies)
  • Damage to the nervous system (epilepsy)
  • Current pregnancy
  • Infections or skin lesions
  • Severe vascular disorders
  • Active neoplasms.

研究者

发起方
Althaia Xarxa Assistencial Universitària de Manresa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meritxell Font Prat

Medical doctor

Althaia Xarxa Assistencial Universitària de Manresa

研究点 (2)

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