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Trial registered on ANZCTR


Registration number
ACTRN12620000040965
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor rehabilitation to improve bowel symptoms, pelvic floor function and quality of life among patients with rectal cancer
Scientific title
Effectiveness of a pre and post-surgical pelvic floor rehabilitation program on bowel symptoms, pelvic floor function and quality of life of patients with rectal cancer
Secondary ID [1] 299795 0
Nil known
Universal Trial Number (UTN)
U1111-1243-4711
Trial acronym
CARRET – CAncer of Rectum REhabilitation Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal cancer 315172 0
Bowel dysfunction 315173 0
Pelvic floor dysfunction 315174 0
Condition category
Condition code
Cancer 313487 313487 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 313488 313488 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Physical Medicine / Rehabilitation 313489 313489 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pelvic floor intervention for rectal cancer patients will be delivered in two stages: (1) pre-rehabilitation and (2) rehabilitation. There is actual recommendation to provide rehabilitation before surgeries in order to prepare patients to improve their functional outcomes. The content of pre-rehabilitation and rehabilitation will include pelvic floor exercises and other techniques aiming to recover pelvic floor maximal function after the surgery and to avoid low anterior resection syndrome (LARS) symptoms.
The pelvic floor intervention, including all stages and techniques, will be provided by a physical therapist with a postgraduation study on pelvic floor treatment with experience in treating rectal cancer patients. This professional will be trained by researchers on the study protocol. The intervention will take place in a private room of Hospital del Salvador.
Stage 1: Pelvic Floor Pre-rehabilitation will be delivered in one session of approximately 40 minutes with physiotherapist educating on the correct contraction of pelvic floor, teaching pelvic floor muscle exercises, and performing capacitive and sensory training with rectal balloon.
Health education will include: the most adequate positioning to evacuate, self-care strategies such as diet with high fiber and low fat, reduce spicy and stimulating food (artificial sweeteners, tea, cola drinks and chocolates), and bowel habits (possibility to have increased urgency to defecate after meal or physical activities).
A booklet was designed for this study with these instructions and exercises will be provided to the patients as well as an audio that will be sent to their cell phones using Whatsapp application. A mobile number with a whatsapp account will be maintained by the pelvic floor therapist to send the audio and contact patients to reinforce instructions to perform PFME at home. Patients will receive a WhatsApp message once a week to remind about the exercises. A closer contact with the therapist may increase patient´s self-efficacy and adherence to the treatment (Sacomori et al, 2015). In addition, patients will receive a diary to register the days when they exercise their pelvic floor in order to check adherence to home-based exercises.
Stage 2: Pelvic Floor Rehabilitation will be delivered in 4 sessions of pelvic floor physiotherapy three weeks before stoma removal, three times for week. Although anorectal function, is not being required for fecal elimination in those with stoma, we will perform PFME and sensory and capacitive training in order to retrain this function and prevent leakage. In addition, patients will receive 5-8 sessions of pelvic floor physiotherapy starting aproximatelly two weeks after stoma removal surgery, over up to one month, three times per week, according to patients´ needs.
Each session will last approximately 40 minutes.
Rehabilitation will start around 6-10 weeks after the surgery, according to physician indication and stoma removal surgery.
The rehabilitation intervention will include pelvic floor exercises, electromiographic biofeedback and capacitive and sensory training:
- Pelvic floor muscle exercises (PFME) will be performed following the protocol of Bø and colleagues (1999) who instructed participants to perform a daily total of 24 to 36 slow contractions (high-intensity maximal voluntary contraction with a 6 to 8 seconds hold). Each slow contraction will be followed by three to four fast contractions and then 6 seconds of rest. In addition, patients will be encouraged to contract the pelvic floor muscles before situations that increase intra-abdominal pressure, known as the ‘knack’ (Millet et al, 1998). Patients will be instructed to repeat these exercises at home every day after removal of ostomy.

- Electromyographic Biofeedback with the equipment New Miotool Wireless® of Miotec following a protocol similar to that used by Kuo et al (2015) in which neuromuscular stimulation of the pelvic floor muscle was performed 2 to 3 times weekly for a total of 12 treatment sessions. We will use a catheter (Anuform) placed into the anal canal for 10 minutes during each treatment session. When the patient could not tolerate the endoanal method we will use external perineal stimulation. The device delivers a square wave, ramp up and down time will be set for 2 seconds, duration of 8 seconds, frequency of 30Hz, on/off time of 1:3, and pulse duration of 300ms. Patients will be instructed to actively contract pelvic floor muscles when the electrical stimulus is on.

- Capacitive and sensory training with a balloon probe will follow the protocol of Liang et al (2016): a trained therapist will perform repeated inflations and deflations of a balloon in stepwise increments of 5 mL of air or saline solution. The patients will be asked to recognize the volume that induced the urge to defecate and the maximal tolerable volume they were able to hold. The patients will be taught to contract the sphincter in response to the perception of rectal distention. This training will be performed once a week with a duration of approximately ten minutes.

Both groups will receive conventional cancer treatment and surgery following ERAS protocols, including 10 sessions of physical exercise (aerobic with a stationary bike up to 60-70% of the maximal heart rate reserve calculated with Karvonen et al (1957) formula and resistance training). Pre-rehabilitation with physical exercises is recommended by ERAS pathways (Gustafsson et al, 2018). A study showed that men with digestive cancers who have a good cardiorespiratory fitness also present a lower risk of mortality (Peel et al, 2009). In a large secondary analysis with colorectal cancer patients, authors concluded that multimodal pre-rehabilitation (physical exercise, nutrition, and coping strategies for anxiety) resulted in greater improvement in walking capacity throughout the whole perioperative period when compared to rehabilitation started after surgery (Minnella et al, 2017). The pre-rehabilitation with physical exercises will be provided by a physical therapist specialized in cancer rehabilitation and trained by researchers on the study protocol. This treatment will be provided at the Service of Physical Medicine and Rehabilitation of Hospital del Salvador.

References:

Bø K, Talseth T, Holme I. Single blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999;318:487–493.
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, et al. Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: 2018. World J Surg 2019; 43:659-695.
Karvonen MJ, Kentala E, Mustala O: The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn 1957; 35: 307–315.
Kuo LJ, Lin YC, Lai CH, Lin YK, Huang YS, Hu CC, Chen SC. Improvement of fecal incontinence and quality of life by electrical stimulation and biofeedback for patients with low rectal cancer after intersphincteric resection.Arch Phys Med Rehabil. 2015 Aug;96(8):1442-7. doi: 10.1016/j.apmr.2015.03.013.
Liang Z, Ding W, Chen W, Wang Z, Du P, Cui L. Therapeutic Evaluation of Biofeedback Therapy in the Treatment of Anterior Resection Syndrome After Sphincter-Saving Surgery for Rectal Cancer. Clin Colorectal Cancer. 2016;15(3):e101-e107. doi:10.1016/j.clcc.2015.11.002
Miller JM, Ashton-Miller JA, Delancey JO. A pelvic muscle pre-contraction can reduce cough-related urine loss in selected women with mild SUI. J Am Geriatr Soc. 1998;46:870–874.
Minnella EM, Bousquet-Dion G, Awasthi R, Scheede-Bergdahl C, Carli F. Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Acta Oncol (Madr). 2017;56(2):295-300. doi:10.1080/0284186X.2016.1268268
Peel JB, Sui X, Matthews CE, et al. Cardiorespiratory Fitness and Digestive Cancer Mortality: Findings from the Aerobics Center Longitudinal Study. Cancer Epidemiol Biomarkers Prev 2009;18:1111-1118.
Sacomori C, Berghmans B, Mesters I, et al. Strategies to enhance self-efficacy and adherence to home-based pelvic floor muscle exercises did not improve adherence in women with urinary incontinence: a randomised trial. J Physiother. 2015; 61: 190–198. DOI: 10.1016/j.jphys.2015.08.005

Intervention code [1] 316050 0
Prevention
Intervention code [2] 316051 0
Rehabilitation
Intervention code [3] 316052 0
Treatment: Devices
Comparator / control treatment
The controll group will not receive pelvic floor pre and rehabilitation.

Control group
Active

Outcomes
Primary outcome [1] 321951 0
Mean score of bowel symptoms
For the main outcome we will use the questionnaire ICIQ-B and the LARS score.
Timepoint [1] 321951 0
(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT)
(T2) Immediatelly after pelvic floor rehabilitation
(T0) baseline
Primary outcome [2] 321952 0
Mean scores of anorectal function.
High resolution anorectal manometry will be used to assess the maximal resting pressure, maximal squeeze pressure, rectal capacity (maximal tolerable volume), and rectal sensitivity (initial sensation threshold). We will use high resolution anorectal manometry with a 24-channels water-perfused catheter (Multiplex, Alacer, Biomedica, Sao Paulo, Brazil). This equipment is a low-cost water perfused system which showed to be adequate for clinical use (Silva et al, 2018; Viebig et al, 2018). According to a previous study we will define as effective an improvement of > 15% in the anorectal manometry parameters. This test will be performed by a trained physician.

Silva RMB, Herbella FAM, Gualberto D. Normative values for a new wáter-perfused high resolution manometry system. Arq Gastroenterol 2018; 55:30-34

Viebig RG, Franco JTY, Araujo SV, Gualberto D. Water-perfused high-resolution anorectal manometry (hram-wp): the first brazilian study. Arq. Gastroenterol. 2018;55(Suppl 1):41-46.
Timepoint [2] 321952 0
(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT)
(T2) Immediatelly after pelvic floor rehabilitation
(T1) before rehabilitation
(T0) baseline
Secondary outcome [1] 376776 0
Mean scores of quality of life
The quality of life will be evaluated with the validated and widely used instrument of the European Organization for Research and Treatment of Cancer Quality of Life Group (EORTC), the Quality of Life Questionnaire Core-30 (QLQ-C30).
Timepoint [1] 376776 0
(T3) Three months after finishing pelvic floor rehabilitation treatment
(T2) Immediatelly after pelvic floor rehabilitation
(T1) before rehabilitation
(T0) baseline
Secondary outcome [2] 376777 0
Mean score of pelvic floor muscle function
A Perineometer Peritron™ (Cardio Design Pty Ltd, Oakleigh, Victoria, Australia) will be used. It is a hand-held clinical biofeedback perineometer used for assessing the strength of the pelvic floor muscles. The device helps teaching patients how to effectively perform pelvic floor exercises (kegels). Pelvic floor contraction causes air pressure in the sensor to be transferred through the connecting tube and displayed on the readout unit. The anal sensor has 15 -19 mm diameter, 30 mm active surface - with seamless medical grade silicone rubber sheath.
Timepoint [2] 376777 0
(T3) Three months after finishing pelvic floor rehabilitation treatment
(T2) Immediatelly after pelvic floor rehabilitation
(T1) before rehabilitation
(T0) baseline
Secondary outcome [3] 376778 0
Adherence to home-based pelvic floor muscle exercises will be measured with an exercise diary. We will record the number of the days per week patients performed the exercises following the instructions of the physical therapist.
Timepoint [3] 376778 0
(T3) Three months after finishing pelvic floor rehabilitation treatment
(T2) Immediatelly after pelvic floor rehabilitation
(T1) before rehabilitation
Secondary outcome [4] 376779 0
Possible adverse events might include excessive bleeding or excessive pain.
Excessive bleeding will be evaluated with a question asking for the frequency of anal bleeding during the last month (never, once a week or less, twice or three times a week, once a day, many times on a day, continually). In addition, amount of bleeding will be quantified with the cup measure (less than half a cup, half a cup, more than half a cup, a cup, and so on).
Excessive pain will be determined as a pain equal or higher than 7 on a Visual Analog Scale from 0 (no pain) to 10 (the worst pain).
Timepoint [4] 376779 0
(T2) Immediatelly after pelvic floor rehabilitation
(T1) Immediatelly after pelvic floor pre-rehabilitation

Eligibility
Key inclusion criteria
Eligible participants for this study will be adults with rectal cancer who will undergo sphincter preserving surgery at Hospital del Salvador, cancer stages I to III, and with enough understanding of Spanish.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Observed cognitive deficit [mini-mental test score lower than 24], and those patients not meeting criteria for inclusion in ERAS protocols, such as: urgency surgery, neurological diseases like stroke, Parkinson or epilepsy, previous gastrectomy, diabetic patient using insulin or with glycosylated hemoglobin higher than 8.5, renal insufficiency, congestive heart failure, anesthetic risk ASA 4. Having previous radiotherapy will not be an exclusion criterion.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be garanteed with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Through a computer-randomised allocations prepared by an independent person on Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: The Hospital has around 50 surgeries for rectal cancer per year. Sample size calculation was performed considering the results of a previous pilot study with 10 participants with rectal cancer undergoing pelvic floor rehabilitation (lIN ET AL, 2018). The study used the ICIQ-B and reported results in the domain Bowel control after rehabilitation [Mean of rehabilitation group=2,8(SD=2,8) and Mean of rehabilitation group=4,9(SD=5,7))]. These values were introduced at an online sample size calculator (CLINCALC) with a power of 80%, alpha 0.05 and enrollment ratio of 1/1, resulting in an estimated sample size of 56 participants, 28 in each group.
Data will be analyzed with descriptive (mean, standard deviation, median, interquartile range, and frequencies) and inferential statistics at the program SPSS®. A normality test will be performed using Kolmogorov Smirnov criteria. For variables which follow normality criteria we will use an independent T test to compare groups. In the case of non-normal distribution, we will use U Mann Whitney test. To compare variables between pre and post intervention we will use a paired T test or a Wilcoxon test. A significance threshold of p<0.05 will be adopted for all tests.

Lin KY, Denehy L, Frawley HC, Wilson L, Granger CL. Pelvic floor symptoms, physical, and psychological outcomes of patients following surgery for colorectal cancer. Physiother Theory Pract. 2018;34(6):442-452. doi:10.1080/09593985.2017.1422165
Clincalc. Sample size calculator. Retrieved from https://clincalc.com/Stats/SampleSize.aspx on 10th February 2019.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22105 0
Chile
State/province [1] 22105 0
Metropolitan region

Funding & Sponsors
Funding source category [1] 304259 0
Government body
Name [1] 304259 0
Conicyt/Fondecyt Inicio - Chilean Government
Address [1] 304259 0
Moneda 1375, Santiago, Región Metropolitana
Country [1] 304259 0
Chile
Primary sponsor type
University
Name
Universidad Bernardo O´Higgins
Address
Avenida Viel 1497, Santiago, Region Metropolitana
Country
Chile
Secondary sponsor category [1] 304502 0
Hospital
Name [1] 304502 0
Hospital del Salvador
Address [1] 304502 0
Av. Salvador 364, Providencia, Región Metropolitana
Country [1] 304502 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304714 0
Servicio de Salud Metropolitano Oriente [Orient Metropolitan Health Service]
Ethics committee address [1] 304714 0
Av. Salvador 364, Providencia, Región Metropolitana
Ethics committee country [1] 304714 0
Chile
Date submitted for ethics approval [1] 304714 0
19/09/2019
Approval date [1] 304714 0
08/10/2019
Ethics approval number [1] 304714 0
not applicable

Summary
Brief summary
This randomized controlled trial will include 56 patients with rectal cancer undergoing sphincter preservation surgery according to the ERAS protocol (Enhanced recovery after surgery) at Hospital del Salvador. Patients will be evaluated with questionnaires (ICIQ-B and the EORTC QLQ C30), anorectal Manometry and perineometer.
The intervention group will receive sessions of pelvic floor rehabilitation, one before surgery and 5-12 sessions after the ileostomy is removed. It will include education, pelvic floor muscle exercises with biofeedback and capacitive and sensory rectal training with a balloon probe.
Hypothesis: We expect that the pre and post-surgical pelvic floor rehabilitation training program will improve bowel symptoms, pelvic floor function and quality of life of patients with rectal cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97970 0
Prof Cinara Sacomori
Address 97970 0
Coordinación Escuela de Kinesiología. Fabrica 1990, piso 2, sala 17, Santiago.
Country 97970 0
Chile
Phone 97970 0
+562 224772209
Fax 97970 0
+562 224772209
Email 97970 0
cinara.sacomori@ubo.cl
Contact person for public queries
Name 97971 0
Prof Cinara Sacomori
Address 97971 0
Coordinación Escuela de Kinesiología. Fabrica 1990, piso 2, sala 17, Santiago.
Country 97971 0
Chile
Phone 97971 0
+562 224772209
Fax 97971 0
+562 224772209
Email 97971 0
cinara.sacomori@ubo.cl
Contact person for scientific queries
Name 97972 0
Prof Cinara Sacomori
Address 97972 0
Coordinación Escuela de Kinesiología. Fabrica 1990, piso 2, sala 17, Santiago.
Country 97972 0
Chile
Phone 97972 0
+562 224772209
Fax 97972 0
+562 224772209
Email 97972 0
cinara.sacomori@ubo.cl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only information of the main and secondary outcomes
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
By contacting the main researcher. Data will be available by contacting by email the main researcher using details on ANZCTR.
E-mail for contact: cinara.sacomori@ubo.cl or csacomori@yahoo.com.br
What supporting documents are/will be available?
No other documents available
Summary results
No Results