Category
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Primary study
Registry of Trials»ANZCTR
Year
»
2020
INTERVENTION: 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 n CONDITION: Cancer ‐ Bowel ‐ Back passage (rectum) or large bowel (colon) Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Physical Medicine / Rehabilitation ‐ Physiotherapy Rectal cancer;Bowel dysfunction;Pelvic floor dysfunction; ; Rectal cancer ; Bowel dysfunction ; Pelvic floor dysfunction SECONDARY OUTCOME: ; 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.[(T3) Three months after finishing pelvic floor rehabilitation treatment ; (T2) Immediatelly after pelvic floor rehabilitation ; (T1) before rehabilitation] ; ; Mean score of pelvic floor muscle function ; A Perineometer Peritronâ„¢ (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.[(T3) Three months after finishing pelvic floor rehabilitation treatment ; (T2) Immediatelly after pelvic floor rehabilitation ; (T1) before rehabilitation ; (T0) baseline] ; ; Mean scores of quality of life ; (T2) Immediatelly after pelvic floor rehabilitation ; (T1) before rehabilitation ; (T0) baseline] ; ; Possible adverse events might include excessive bleeding or excessive pain. PRIMARY OUTCOME: ; Mean score of bowel symptoms; For the main outcome we will use the questionnaire ICIQ‐B and the LARS score.[(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT); (T2) Immediatelly after pelvic floor rehabilitation; (T0) baseline]; ; 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.; [(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT); (T2) Immediatelly after pelvic floor rehabilitation; (T1) before rehabilitation; (T0) baseline]; ; 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).[(T3) Three months after finishing pelvic floor rehabilitation treatment ; 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).[(T2) Immediatelly after pelvic floor rehabilitation ; (T1) Immediatelly after pelvic floor pre‐rehabilitation] ; 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.
Epistemonikos ID: ca1ae8280342c25c671752ea2dd2c321a87f78b3
First added on: Aug 24, 2024