Constipation Clinical Trial
Official title:
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation
Verified date | January 2010 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
Comparative study between surgical and non surgical treatment of anismus in patients with
symptoms of obstructed defecation.
Anismus is a significant cause of chronic constipation. This study came to compare the
results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients.
Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional
constipation were included in this study. All patients underwent anorectal manometry,
balloon expulsion test, defecography, and electromyography activity of the EAS. All patients
had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group
I patients received biofeedback therapy, two times per week for about 1 month. Group II
patients were injected with BTX- A. Group 111 partial division of puborectalis was done.
Follow up was conducted weekly in the first month then monthly for about 1 year.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 69 Years |
Eligibility |
Inclusion Criteria: - 60patients fulfilled Rome II criteria for functional constipation - All patients were unresponsive to laxatives or enema use Exclusion Criteria: - Pregnant patients - Patients with sphincteric defect - Any patient proved to have colonic inertia by colon transit time - Any patient with previous history of pelvic surgery e.g. mesh rectopexy - Duhamel operation were excluded |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Ayman Elnakeeb | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Farid M, El Monem HA, Omar W, El Nakeeb A, Fikry A, Youssef T, Yousef M, Ghazy H, Fouda E, El Metwally T, Khafagy W, Ahmed S, El Awady S, Morshed M, El Lithy R. Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009 Jan;24(1):115-20. doi: 10.1007/s00384-008-0567-0. Epub 2008 Aug 22. — View Citation
Farid M, Youssef T, Mahdy T, Omar W, Moneim HA, El Nakeeb A, Youssef M. Comparative study between botulinum toxin injection and partial division of puborectalis for treating anismus. Int J Colorectal Dis. 2009 Mar;24(3):327-34. doi: 10.1007/s00384-008-060 — View Citation
Kamm MA, Hawley PR, Lennard-Jones JE. Lateral division of the puborectalis muscle in the management of severe constipation. Br J Surg. 1988 Jul;75(7):661-3. — View Citation
Maria G, Brisinda G, Bentivoglio AR, Cassetta E, Albanese A. Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Dis Colon Rectum. 2000 Mar;43(3):376-80. — View Citation
Park UC, Choi SK, Piccirillo MF, Verzaro R, Wexner SD. Patterns of anismus and the relation to biofeedback therapy. Dis Colon Rectum. 1996 Jul;39(7):768-73. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score) | 1 year | Yes | |
Secondary | per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication | 1 year | Yes |
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