Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Primary Purpose
Obstructed Defecation, Anismus, Constipation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BFD
PDPR
BTX A
Sponsored by
About this trial
This is an interventional treatment trial for Obstructed Defecation focused on measuring obstructed defecation, constipation, puborectalis
Eligibility 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
Sites / Locations
- Ayman Elnakeeb
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1:BFD
2 BTX A
3: PDPR
Arm Description
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
Injected with BTX-A in the left lateral position; anesthesia was not required
Inner half of puborectalis sling was divided on each side by using a scalpel NO
Outcomes
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735605
Brief Title
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Official Title
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Key words:
Obstructed defecation, chronic constipation, puborectalis, pelvic floor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructed Defecation, Anismus, Constipation
Keywords
obstructed defecation, constipation, puborectalis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1:BFD
Arm Type
Active Comparator
Arm Description
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
Arm Title
2 BTX A
Arm Type
Active Comparator
Arm Description
Injected with BTX-A in the left lateral position; anesthesia was not required
Arm Title
3: PDPR
Arm Type
Active Comparator
Arm Description
Inner half of puborectalis sling was divided on each side by using a scalpel NO
Intervention Type
Other
Intervention Name(s)
BFD
Other Intervention Name(s)
BIOFEEDBACK RETRAINING
Intervention Description
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
Intervention Type
Procedure
Intervention Name(s)
PDPR
Other Intervention Name(s)
PARTIAL DIVISION OF PUBORECTALIS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
BTX A
Other Intervention Name(s)
BOTILINUM TOXIN
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman elnakeeb, MD
Organizational Affiliation
MANSUORA UNIVERSITY HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman Elnakeeb
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
18719924
Citation
Farid M, El Monem HA, Omar W, El Nakeeb A, Fikry A, Youssef T, Yousef M, Ghazy H, Fouda E, El Metwally T, Khafagy W, Ahmed S, El Awady S, Morshed M, El Lithy R. Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009 Jan;24(1):115-20. doi: 10.1007/s00384-008-0567-0. Epub 2008 Aug 22.
Results Reference
background
PubMed Identifier
19039596
Citation
Farid M, Youssef T, Mahdy T, Omar W, Moneim HA, El Nakeeb A, Youssef M. Comparative study between botulinum toxin injection and partial division of puborectalis for treating anismus. Int J Colorectal Dis. 2009 Mar;24(3):327-34. doi: 10.1007/s00384-008-0609-7. Epub 2008 Nov 29.
Results Reference
result
PubMed Identifier
10733120
Citation
Maria G, Brisinda G, Bentivoglio AR, Cassetta E, Albanese A. Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Dis Colon Rectum. 2000 Mar;43(3):376-80. doi: 10.1007/BF02258305.
Results Reference
result
PubMed Identifier
3416122
Citation
Kamm MA, Hawley PR, Lennard-Jones JE. Lateral division of the puborectalis muscle in the management of severe constipation. Br J Surg. 1988 Jul;75(7):661-3. doi: 10.1002/bjs.1800750713.
Results Reference
result
PubMed Identifier
8674369
Citation
Park UC, Choi SK, Piccirillo MF, Verzaro R, Wexner SD. Patterns of anismus and the relation to biofeedback therapy. Dis Colon Rectum. 1996 Jul;39(7):768-73. doi: 10.1007/BF02054442.
Results Reference
result
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Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
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