Clinical trial NCT00735605: Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Official title: Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructed Defecation
Anismus
Constipation
Keywords: obstructed defecation
constipation
puborectalis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 1 year
Secondary outcomes:
measure: per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman Elnakeeb
Study officials:
affiliation: MANSUORA UNIVERSITY HOSPITAL
name: ayman elnakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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/s00384-008-0609-7. Epub 2008 Nov 29.
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. doi: 10.1007/BF02258305.
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. doi: 10.1002/bjs.1800750713.
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. doi: 10.1007/BF02054442.