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NCT Number: NCT00735605

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.

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.

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Key information

Conditions

Obstructed Defecation Anismus Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman Elnakeeb

Al Mansurah, Egypt

About this study

Key words:

Obstructed defecation, chronic constipation, puborectalis, pelvic floor

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFD

Other

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

PDPR

Procedure

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

BTX A

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 15, 2008
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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