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Chronic constipation, particularly due to dyssynergic defecation, is common and impacts quality of life. Biofeedback therapy (BFT) is the most effective conservative treatment, teaching patients to coordinate abdominal and anal muscles during defecation. In standard practice, the rectal balloon used in high-resolution anorectal manometry (HRAM) and biofeedback is left deflated, though some centres inflate it to simulate a more natural urge to defecate.
However, the efficacy of this modification has not been validated. This study aims to determine whether performing BFT with the balloon inflated to a patient's defecatory desire volume enhances physiological coordination and patient understanding compared to the standard deflated approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon deflated on push manoeuvre during biofeedback therapy | Active Comparator |
| |
| Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy. | Other | This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological improvement | The primary outcome measure for this study is the change in anorectal pressure gradient (the difference between rectal and anal canal pressures) recorded during the push manoeuvre on high-resolution anorectal manometry (HRAM). This measurement reflects how effectively the rectal and anal muscles work together to open the bowels - known as defecatory coordination. The study will compare each participant's average pressure gradient when performing push manoeuvres:
An improvement in the pressure gradient (i.e. a higher rectal pressure relative to anal pressure) will indicate better defecatory performance. | During a single study visit; baseline measurements (balloon deflated) and intervention measurements (balloon inflated to the participant's desire-to-defecate volume) are obtained sequentially during the same HRAM examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience | The secondary outcome measures for this study focus on participants' experiences and perceptions during the biofeedback session, as well as the consistency of their physiological responses.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Gallagher, Clinical Scientist | Contact | 01482624036 | john.gallagher6@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull University Teaching Hospitals | Recruiting | Hull | HU16 5JQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Picking, Christopher MD1; Buddam, Avanija MBBS2; Chandra, Subhash MBBS2. S1723 Rectal Perforation; A Rare Complication From Anorectal Manometry: A Case Report and Literature Review. The American Journal of Gastroenterology 116():p S765-S766, October 2021. | DOI: 10.14309/01.ajg.0000780424.47437.24 | ||
| 18023112 | Background | Park JS, Kang SB, Kim DW, Kim NY, Lee KH, Kim YH. Iatrogenic colorectal perforation induced by anorectal manometry: report of two cases after restorative proctectomy for distal rectal cancer. World J Gastroenterol. 2007 Dec 7;13(45):6112-4. doi: 10.3748/wjg.v13.45.6112. | |
| 28660663 |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| No intervention | Other | The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated. |
|
| During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session. |
| Background |
| Skardoon GR, Khera AJ, Emmanuel AV, Burgell RE. Review article: dyssynergic defaecation and biofeedback therapy in the pathophysiology and management of functional constipation. Aliment Pharmacol Ther. 2017 Aug;46(4):410-423. doi: 10.1111/apt.14174. Epub 2017 Jun 29. |
| 33893763 | Background | Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678. |
| 25828100 | Background | Rao SS, Benninga MA, Bharucha AE, Chiarioni G, Di Lorenzo C, Whitehead WE. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil. 2015 May;27(5):594-609. doi: 10.1111/nmo.12520. Epub 2015 Apr 1. |
| 29996755 | Background | Black CJ, Ford AC. Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management. Med J Aust. 2018 Jul 16;209(2):86-91. doi: 10.5694/mja18.00241. |
| 36950062 | Background | Bae SH. Dyssynergic Defecation in Chronically Constipated Children in Korea. Pediatr Gastroenterol Hepatol Nutr. 2023 Mar;26(2):127-133. doi: 10.5223/pghn.2023.26.2.127. Epub 2023 Mar 7. |
| 39506302 | Background | Shi H, Li L, Huang L, Xia W, Zhu M, Zhao Y. High-Resolution Anorectal Manometry and Balloon Expulsion Test Outcomes in Functional Constipation: A Comparative Study. Med Sci Monit. 2024 Nov 7;30:e944599. doi: 10.12659/MSM.944599. |
| 33536850 | Background | Hite M, Curran T. Biofeedback for Pelvic Floor Disorders. Clin Colon Rectal Surg. 2021 Jan;34(1):56-61. doi: 10.1055/s-0040-1714287. Epub 2020 Sep 4. |
| 27144630 | Background | Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print. |
| 36919830 | Background | Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148. |
| 27270989 | Background | Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060. |
| 31893959 | Background | Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2. |
| 38396390 | Background | Marinica Grando L, Halfvarson J, van Nieuwenhoven M. Rectal Sensory and Compliance Testing: A Method Comparison Study between High-Resolution Anorectal Manometry and Barostat Investigations. Diagnostics (Basel). 2024 Feb 6;14(4):351. doi: 10.3390/diagnostics14040351. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |