Balloon Inflation in Biofeedback

Официальное название

Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy

Обзор

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.

Вмешательства

• Другое Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.
  This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique.
• Другое No intervention
  The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.

Первичные конечные точки

• Physiological improvement [Срок оценки: 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.]

Вторичные конечные точки (1)

• Patient experience [Срок оценки: During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.]

Критерии участия

Критерии включения

• dyssynergia, constipation, obstructive defecation

Критерии исключения

• Patients with anorectal inflammation due to conditions such as solitary rectal ulcer syndrome
• Patients with significantly altered anorectal anatomy due to abnormalities such as large rectocele, rectal prolapse or intussusception
• History of major anorectal surgery
• Unable to be investigated with HR-ARM due to contraindications such as recent anorectal surgery (<6 weeks), active anorectal infections, severe anal pain or fissures(?), thrombosed haemorrhoids, or inability to tolerate anorectal catheters
• Patients with pre-existing co-morbid inflammatory gastrointestinal conditions, including
• Coeliac and Crohn's disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Hull University Teaching Hospitals — Hull

Публикации

• 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
• 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. PMID 18023112
• 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. PMID 28660663
• 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. PMID 33893763
• 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. PMID 25828100
• 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. PMID 29996755
• 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. PMID 36950062
• 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. PMID 39506302

Идентификаторы

NCT: NCT07705542 · 367053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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