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| Sponsored by: |
Mansoura University |
|---|---|
| Information provided by: | Mansoura University |
| ClinicalTrials.gov Identifier: | NCT00735605 |
Purpose
Initial improvement was recorded after BFB retraining, BTX-A injection, and OPDPR in 50%, 70.83% and 100% (P=0.0001) while long term success was 25% after BFB retraining , 33.3% post BTX- A injection and 66.67%) post OPDPR (P=0.05). Manometric relaxation was achieved significantly postBFB and postBTX A injection and postPDPR.
| Condition | Intervention |
|---|---|
|
Obstructed Defecation,Anismus |
Other: BFD Procedure: PDPR Other: BTX A |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation |
| Enrollment: | 72 |
| Study Start Date: | September 2003 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1:BFD
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
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Other: BFD
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
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2 BTX A
Injected with BTX- A in the left lateral position; anesthesia was not required
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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
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3: PDPR
Inner half of puborectalis sling was divided on each side by using a scalpel NO
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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
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Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation
Abstract
Purpose:
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. Results: Initial improvement was recorded after BFB retraining, BTX-A injection, and OPDPR in 12 patients (50%), 17 patients (70.83%) and 24 patients (100%) respectively (P=0.0001) while long term success was 6 patients (25%) after BFB retraining , 8 patients (33.3%) post BTX- A injection and 16 patients (66.67%) post OPDPR (P=0.05). Manometric relaxation was achieved significantly postBFB and postBTX A injection and postPDPR with significant difference.
Conclusion
Biofeedback retraining to the puborectalis muscle has a limited therapeutic effect on patients suffering from anismus.BTX-A injection seems to be successful for temporary treatment of anismus. bilateral partial division of puborectalis is found to be an effective in treating anismus. It has a relatively lower morbidity in contrast to its higher success rate.
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 |
| Sampling Method: | Non-Probability Sample |
72 patients fulfilled Rome II criteria for functional constipation These patients were randomly divided into three groups. Group I (BFB training group) consisted of 24 patients, 16 females and 8 males, with a mean age 39.6 + 15.94 years ( ranging from 20- 69 years) who underwent 8 sessions of biofeedback retraining . Group II (BTX A group) consisted of 24 patients, 17 females and 7 males with a mean age 34.7+12.3 years (range from 20-63 years), all patients in group II underwent botulinum toxin type A (BTX-A) injection and Group III comprised (surgical group ) of 24 patients , 16 females and 8 males patients with a mean age 38.3 ± 8 years (range from 24- 53years), all patients in group III underwent bilateral open partial division of puborectalis muscle (OPDPR)
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | mansour universty hospital ( ayman el nakeeb ) |
| Study ID Numbers: | anismus surgical and non |
| Study First Received: | August 14, 2008 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00735605 |
| Health Authority: | Egypt: Institutional Review Board |
|
obstructed defecation constipation puborectalis |
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Constipation Botulinum Toxin Type A |
