Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Obstructed Defecation
Anismus
Constipation
 Other: BFD
Procedure: PDPR
Other: BTX A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
Active Comparator: 2 BTX A
Injected with BTX-A in the left lateral position; anesthesia was not required
 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: 3: PDPR
Inner half of puborectalis sling was divided on each side by using a scalpel NO
 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

Detailed Description:

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735605

Locations
Egypt
Ayman Elnakeeb
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ayman elnakeeb, MD MANSUORA UNIVERSITY HOSPITAL
  More Information

Publications:

Responsible Party: ayman el nakeeb, mansour universty hospital
ClinicalTrials.gov Identifier: NCT00735605     History of Changes
Other Study ID Numbers: anismus surgical and non
Study First Received: August 14, 2008
Last Updated: January 12, 2010
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
obstructed defecation
constipation
puborectalis

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013