Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients

Constipation Clinical Trial

Official title:

Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735605
• Other study ID #: anismus surgical and non
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: January 12, 2010
• Start date: September 2006
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anismus
• Constipation
• Obstructed Defecation

Intervention

Other:
• BFD
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip

Procedure:
• PDPR
A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain

Other:
• BTX A
A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient

Locations

Country	Name	City	State
Egypt	Ayman Elnakeeb	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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

Outcome

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