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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00735605
First received: August 14, 2008
Last updated: January 12, 2010
Last verified: January 2010

August 14, 2008
January 12, 2010
September 2006
January 2010   (final data collection date for primary outcome 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) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
therapeutic effect of Biofeedback retraining to the puborectalis muscle .BTX-A injection . bilateral partial division of puborectalis on anismus. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00735605 on ClinicalTrials.gov Archive Site
per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
therapeutic effect of Biofeedback retraining to the puborectalis muscle .BTX-A injection . bilateral partial division of puborectalis on anismus. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation

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.

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obstructed Defecation
  • Anismus
  • Constipation
  • Other: BFD
    The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
    Other Name: BIOFEEDBACK RETRAINING
  • 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 Name: PARTIAL DIVISION OF PUBORECTALIS
  • 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
    Other Name: BOTILINUM TOXIN
  • Active Comparator: 1:BFD
    The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
    Intervention: Other: BFD
  • Active Comparator: 2 BTX A
    Injected with BTX-A in the left lateral position; anesthesia was not required
    Intervention: Other: BTX A
  • Active Comparator: 3: PDPR
    Inner half of puborectalis sling was divided on each side by using a scalpel NO
    Intervention: Procedure: PDPR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00735605
anismus surgical and non
Yes
ayman el nakeeb, mansour universty hospital
Mansoura University
Not Provided
Principal Investigator: ayman elnakeeb, MD MANSUORA UNIVERSITY HOSPITAL
Mansoura University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP