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

January 12, 2010 updated by: Mansoura University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Ayman Elnakeeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • PARTIAL DIVISION OF PUBORECTALIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: ayman elnakeeb, MD, MANSUORA UNIVERSITY HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anismus surgical and non

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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