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临床试验/NCT04949646
NCT04949646招募中不适用

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

Larissa University Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
2
主要终点
Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire

研究概览

简要总结

The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.

详细描述

The introduction of Total Mesorectal Excision (TME) resulted to the improvement of the overall survival and local recurrence rates of rectal cancer patients. However, the associated urogenital and anorectal functional deficit has a significant effect on the postoperative quality of life of the patient. More specifically, the postoperative rates of urogenital and sexual dysfunction that have been reported in the various series, are estimated at the levels of 70% and 90%, respectively. Additionally, TME is associated with the development of the low anterior syndrome (LARS). LARS is characterized by the onset of fecal incontinence, due to injury in the autonomic nerve plexuses that innervate the internal anal sphincter (IAS); who in turn is responsible for the 52-85% anal resting tone. According to a recent study, 38.8% and 33.7% of patients with normal preoperative urogenital function, developed postoperative stool and urine incontinence, respectively.

It becomes apparent that the incidence rates of these complications vary between the various series, mainly due to their small sample size, the lack of comparative data, the short follow up period, the use of non-validated tools and their retrospective design. Several predictive factors of these adverse events have been suggested in the literature, including old age, tumors located less than 12 cm from the anal verge, preoperative radiotherapy and injury to the pelvic autonomous nerves.

The clinical and functional anatomy of the pelvis are quite complex. The inferior hypogastric plexus is formed by the parasympathetic pelvic nerves, deriving from the I2-I4 and the sympathetic hypogastric nerve. It is a neural anatomic structure that carries organ-specific nerve fibers. Visual identification of the plexus is quite difficult, for various reasons, including the complexity of the nerve distribution, the narrow pelvis, the voluminous mesorectum, obesity, previous pelvic operations, neoadjuvant radiotherapy, locally advanced tumors, intraoperative bleeding and the extensive use of diathermy. According to the current literature, identification of the autonomous pelvic plexus is achievable in 72% of cases, whereas partial localization is possible only in 10.7% of patients.

Theoretically, intraoperative neuromonitoring of the pelvic autonomous nerves (pIONM), could quantify intraoperative nerve injuries, while in parallel, contribute to the improvement of the patients' postoperative quality of life. Several pIONM techniques have been described, including intra-urethral and intra-vesical pressure measurements. However, it was found that intermittent neuromonitoring objectifies the macroscopic integrity assessment of the sacral plexus. Recently, a promising technique, based on the simultaneous electromyography of the IAS and bladder manometry was developed, with encouraging results. During pIONM, the surgeon delivers electric stimuli to the autonomic nerve structures through a hand-held stimulator. At the same time, electromyogram changes of the IAS and the external anal sphincter (EAS), alongside intravesical pressure gradients are assessed.

Intraoperative neuromonitoring has been evaluated in several experimental studies. In a recent study, intraoperative simulation of the inferior hypogastric plexus with a bipolar stimulator resulted to the appearance of a measurable and repeatable electromyographic signal from the IAS.

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 (Participant)

盲法说明

The patient will be blinded regarding the allocation group. Blinding will not exist at the level of the surgeon, the anaesthesiologist, and the investigator responsible for the data recording

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed rectal cancer
  • Surgical resection with TME
  • <90 years old
  • Signed informed consent

排除标准

  • Emergency operation
  • Presence of pacemaker
  • Partial mesorectal excision
  • Sepsis or systematic infection
  • Physical or mental impairment
  • Pregnancy or nursing
  • Insufficient preoperative data for the urogenital/ anorectal function
  • Lack of compliance with the research process

研究组 & 干预措施

pIONM

Experimental

In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used.

Prior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R/L. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.

干预措施: Pelvic Intraoperative Neuromonitoring (Other)

Control

No Intervention

In the control group pIONM will not be performed intraoperatively

结局指标

主要结局

Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire

时间窗: Preoperatively, 3 months postoperatively

Change in the quality of life of the patient, at 3 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome

次要结局

  • Operative time(Intraoperative period)
  • Intraoperative bleeding(Intraoperative period)
  • Local recurrence(1 year postoperatively)
  • Postoperative discharge time(Maximum time frame 15 days postoperatively)
  • Postoperative complications(1 month postoperatively)
  • Negative resection margin(1 month postoperatively)
  • Bladder capacity(Preoperatively and 2 months postoperatively)
  • Voiding volume(Preoperatively and 2 months postoperatively)
  • Bladder compliance(Preoperatively and 2 months postoperatively)
  • Maximum urinary flow rate(Preoperatively and 2 months postoperatively)
  • Post-void residual(Preoperatively and 2 months postoperatively)
  • Sphincter zone length(Preoperatively and 2 months postoperatively)
  • Push test(Preoperatively and 2 months postoperatively)
  • Difference in the quality of life of the patient, based on the SF-36 questionnaire(Preoperatively, 6, 12, 24 months postoperatively)
  • Difference in the sexual function of the patient, based on the FSFI questionnaire(Preoperatively, 3, 6, 12, 24 months postoperatively)
  • Difference in the low anterior syndrome symptoms of the patient, based on the LARS questionnaire(Preoperatively, 3, 6, 12, 24 months postoperatively)
  • Detrusor pressure at maximum flow(Preoperatively and 2 months postoperatively)
  • Anal canal resting phase pressure(Preoperatively and 2 months postoperatively)
  • Short squeeze test(Preoperatively and 2 months postoperatively)
  • Long squeeze test(Preoperatively and 2 months postoperatively)
  • Cough test(Preoperatively and 2 months postoperatively)
  • RAIR test(Preoperatively and 2 months postoperatively)
  • Difference in the erectile function of the patient, based on the IIEF questionnaire(Preoperatively, 3, 6, 12, 24 months postoperatively)
  • Difference in the prostate symptoms of the patient, based on the IPSS questionnaire(Preoperatively, 3, 6, 12, 24 months postoperatively)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Perivoliotis Konstantinos

Perivoliotis Konstantinos, Principal Investigator

Larissa University Hospital

研究点 (2)

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