Clinical Research Directory

Defecation Patterns in Constipated Patients

Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex/process in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.

The ReVo Study: Low-volume vs High-volume Rectal Irrigation

Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support. Two systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology. Therefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum. This trial/research aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum. The main questions it aims to answer are: * if one type of rectal irrigation is superior to the other * whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound * assess the acceptability and response rates to rectal irrigation. Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day. Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.