Anal Continence After High-Intensity Focused Ultrasound (HIFU) Treatment Clinical Trial
Official title:
Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and High-Intensity Focused Ultrasound (HiFU) , through the aplication of questionnaires and Anorectal Manometry before and after this treatment.
Primary Investigate the presence of hypotonic anal sphincter after anorectal dilatation and
HiFU procedure
Secondary
1. Detect the presence of fecal incontinence
2. Demonstrate the absence of alterations in the fecal pattern
3. Detect alterations in rectal filling sensation and e evacuation desire
4. Evaluate anal pain
PATIENTS AND METHODS Thirty (30) consecutive patients indicated for treatment of prostate
cancer with HIFU (FocalOneR, Edap TMS, France) will be selected. The specific inclusion and
exclusion criteria are specified below. All should present the diagnosis of usual acinar
adenocarcinoma of prostate Gleason score 6 (3 + 3) or Gleason 7 (3 + 4). No patient may have
PSA greater than 10.0. A digital prostate exam should show prostate-restricted disease. The
clinical staging should be ≤ cT2a. There will be no age limit for inclusion. Patients may not
have anatomical, functional or pathological alterations of the anal canal and rectus or
history of anorectal trauma and may not have a diagnosis of psychoneurologic diseases, such
as: Depression, Stroke, Schizophrenia, Degenerative Neurological Diseases or others.
All patients will be submitted to the manometry study the week prior to HIFU together with
the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal
Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This
examination will be conducted in a friendly environment and by experienced professionals.
Patients who met the inclusion and exclusion criteria and who signed the informed consent
form will be linked to the study.
REALIZATION OF HIFU, MANOMETRY AND QUESTIONNAIRES All patients treated with HIFU should have
prostate volume less than 40g for treatment of hemigland or 30g for whole gland treatments.
Patients will have rectal cleansing for 3 to 6 hours prior to the procedure and will be
treated according to the FocalOneR treatment protocol, with general anesthesia and bladder
catheterization with Foley 16 or 18 Fr catheter. After general anesthesia and positioning,
digital dilatation of the anal sphincter and introduction of the HIFU probe will be
performed. With the end of treatment, the probe is withdrawn, and the patient awake from the
anesthesia. In the anesthetic recovery room will be applied the visual pain scale that will
also be applied at the time of hospital discharge and on the thirtieth day of the procedure.
Patients may receive common analgesics as needed.
To perform the manometry examination it is necessary that the patient is awake, without
effect of sedatives and cooperating with examination. A suppository will be used to clean the
rectum 3 to 4 hours prior to the examination. And the pressures of rest and voluntary
contraction of the anal sphincter will be evaluated, as well as the behavior of the pubortal
muscle during the evacuation maneuver. Retinal inhibitory reflex (RIRA), sensitivity and
rectal capacity will also be evaluated.
Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at
the time of manometry.
PLACE OF ACHIEVEMENT OF RESEARCH AND FINANCIAL RESOURCES The selected patients will perform
the tests of manometry, the HIFU procedure, the follow-up and treatment of possible
complications in the Hospital of Transplants Euryclides de Jesus Zerbini (Hospital
Brigadeiro) through the Unique Health System (UHS/SUS). This research does not have any
private financial support. The funds will come from the SUS and there will be no excess
expenses to the SUS.
THE SAMPLE AND TIME OF RECRUITMENT Thirty (30) consecutive patients will be selected, with
indication of treatment of malignant neoplasm of the prostate by the HIFU method, and that
they respect the criteria of inclusion and exclusion. The estimated time for recruitment of
the completed sample is 30 days. And the deadline for the entire study will be 60 days from
the start of the study.
STATISTIC Statistical analysis will be performed with the help of SPSS 17.0 for Windows.
Results such as mean, median and prevalence will be calculated. The significance level
adopted will be 0.05.
COSTS All manometry examinations will be performed at the Paulista Endoscopy Center (CPE -
CNPJ: 48.109.011 / 0001-30). The CPE will make available all the physical structure,
employees, trained doctors and materials needed to perform the manometry exams. Patients will
be asked to attend CPE (Rua Cincinato Braga, 37, CJ. 12, 1st floor, Bela Vista, SP) and NO
COST TO THE BRIGADEIRO HOSPITAL, FOR PATIENTS AND / OR RESEARCHERS.
RISK ANALYSIS, PROTECTION MEASURES AND SUSPENSION OF RESEARCH This research does not involve
any experimental procedure. The treatment of patients with HIFU is already established with
specific cancer survival results found in the literature for 10 years (7, 8).
The manometry exam is a very safe technique and practically free of complications. In very
rare cases, small rectal bleeding of spontaneous resolution, low intensity pain in the anal
region, and very rarely, perforation of the rectal mucosa may occur with the need for
surgery. (19) In any case, the presence of complications will be treated at the Brigadeiro
Hospital, which has urologists 24 hours a day, 7 days a week. In addition, the Brigadeiro
Hospital has emergency room for patients 24/7 with clinicians on call and support general
surgery staff. The patients will be instructed to return immediately to the Hospital in case
of any complications, where they will be attended by a doctor of the urology team and
communicated the occurrence to the researchers.
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