|- candidate number||29726|
|- NTR Number||NTR7581|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-okt-2018|
|- Secondary IDs||P18.090 P1a |
|- Public Title||Pelvic floor physiotherapy in treatment of Chronic Anal Fissure
|- Scientific Title||Pelvic floor physiotherapy in treatment of Chronic Anal Fissure, a randomized controlled trial|
|- hypothesis||We hypothesize that treatment with pelvic physiotherapy in patients with a chronic anal fissure and concomitant pelvic floor dysfunction will result in an improvement of quality of life.
We also aim to provide a management protocol for Pelvic floor physiotherapy(PFMT) including biofeedback with EMG in the treatment of a chronic anal fissure.
|- Healt Condition(s) or Problem(s) studied||Anal fissure, Treatment, Pelvic floor dysfunction, Dyssynergia|
|- Inclusion criteria|| All patients > 18 years old |
Chronic anal fissure(anal fissure existing longer than 6 weeks) and pelvic floor dysfunction
|- Exclusion criteria|| Patients presenting an abscess or fistula |
Patients with Crohns disease or ulcerative colitis;
Patients who received prior anal radiation therapy;
Patients with diagnosed anorectal malignancy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2018|
|- planned closingdate||1-dec-2020|
|- Target number of participants||133|
|- Interventions||Interventiongroup Pelvic Floor Physiotherapy (PFMT)including biofeedback following a standardized treatmentprotocol|
Controlgroup: delayed PFMT including biofeedback following a standardized treatment protocol
|- Primary outcome||VAS-scores(pain)|
Quality of life
|- Secondary outcome||- Prevalence of pelvic floor dysfunction in chronic anal fissure measured by physical examination and balloon expulsion test|
- Difference in EMG signals of the pelvic floor before and after treatment;
- Relation between chronic anal fissures and other pelvic floor dysfunctions;
-PROM before and after PFMT
|- Timepoints||T0 start treatment|
T1 after 8 weeks treatment groupA
T2 after 20 weeks after treatment groep B
T3 after one year follow up
Pain 4 timepoints
SF36 4 timepoints
PROM 4 timepoints
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Danielle van Reijn|
|- CONTACT for SCIENTIFIC QUERIES|| Ingrid Han-Geurts|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Proctos Clinics Bilthoven|
(Source(s) of Monetary or Material Support)
|- Brief summary||The PAF-study is a randomized controlled study which is focused on the efficacy of treatment of chronic anal fissure and concomitant pelvic floor dysfunction with pelvic floor physiotherapy including biofeedback and/or electrostimulation.
A chronic anal fissure is a painful problem involving a tear or ulcer in the epithelium of the anus which exists longer than six weeks. Chronic anal fissure is conservatively treated, aimed at relaxation of the internal anal sphincter and normalization of the defecation pattern.
At this moment patients are treated with local ointments like isorbide nitrate or diltiazem. Furthermore, a fibre enriched diet, extra fluids, laxatives are advocated. In 90% of patients complaints will resolve after 3 months with this regime. However in 10% of patients, anal fissure does not heal, becomes inflammated and fibrotic. In those cases, local botulinum toxin injections and lateral internal sphincterotomy (LIS) and/or fissurectomie are the next step. However, lateral internal sphincterotomy has a potential hazard of incontinence (5% to 31%). Nonetheless, lateral internal sphincterotomy is currently the standard of care for surgical treatment of fissures.
Botulinum toxin is used as an effective treatment modality for anal fissure. It is considered as a minimal invasive procedure with minor adverse effects and good success rate. However, side effects include flatus and fecal incontinence, sometimes permanent.
A proportion of patients with chronic anal fissure have a history of constipation and obstructed defecation. Consequently, these patients have complaints of excessive straining, incomplete evacuation, and hard stools together with infrequent stooling.
One of the causes could be pelvic floor dysfunction as a contributing factor. A non-relaxing pelvic floor and/or pelvic floor dyssynergia result in an increase in the anorectal angle, prohibiting the normal passage of stool.
Dyssynergia is characterized by a failure of the abdominal-, rectal-, pelvic floor- and anal sphincter muscles to effectively coordinate and complete the process of defecation.
Dyssynergia is diagnosed by a validated measurement instrument, rectal balloontest and rectal examination of the pelvic floor muscles.
Dyssynergia can be effectively treated by pelvic floor physiotherapy including biofeedback therapy and/or electrostimulation. Effects of treatment of pelvic floor dysfunction on healing of a chronic anal fissure is currently unknown in literature.
We hypothesize that treatment with pelvic physiotherapy in patients with a chronic anal fissure and concomitant pelvic floor dysfunction will result in an improvement of quality of life.
We also aim to provide a management protocol for Pelvic floor physiotherapy in the treatment of chronic anal fissure.
Finally, short- and long term outcome of treatment of a chronic anal fissure using this regime will be described.
|- Main changes (audit trail)|
|- RECORD||25-okt-2018 - 7-nov-2018|