Obstructed DefecationNCT00735605
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
A study testing BFD, PDPR and BTX A in people with Obstructed Defecation and Anismus, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Obstructed Defecation, Anismus, Constipation
- What is being tested?
- BFD, PDPR and BTX A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60patients fulfilled Rome II criteria for functional constipation
- All patients were unresponsive to laxatives or enema use
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Key words:
Obstructed defecation, chronic constipation, puborectalis, pelvic floor
- Conditions
- Obstructed Defecation, Anismus, Constipation
- Being tested
- BFD, PDPR, BTX A
- Keywords
- obstructed defecation, constipation, puborectalis
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFDOther
Also called BIOFEEDBACK RETRAINING
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
PDPRProcedure or surgery
Also called PARTIAL DIVISION OF PUBORECTALIS
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
BTX AOther
Also called BOTILINUM TOXIN
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
| Study group | Role | What they receive |
|---|---|---|
| 1:BFD | Active comparator | The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip Receives: Other: BFD |
| 2 BTX A | Active comparator | Injected with BTX-A in the left lateral position; anesthesia was not required Receives: Other: BTX A |
| 3: PDPR | Active comparator | Inner half of puborectalis sling was divided on each side by using a scalpel NO Receives: Procedure: PDPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructed DefecationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ayman elnakeeb, MD, Principal investigator, MANSUORA UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735605
- Sponsor's protocol ID
- anismus surgical and non
- Status last verified
- Jan 2010
- First submitted
- 14 Aug 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18719924Farid 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.
PubMed 19039596Maria 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.
PubMed 10733120Kamm 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.
PubMed 3416122Park 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.
PubMed 8674369
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation
- ClinicalTrials.gov ID
- NCT00735605
- Acronym / sponsor ID
- anismus surgical and non
- Conditions
- Obstructed Defecation, Anismus, Constipation
- Keywords
- obstructed defecation, constipation, puborectalis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1:BFD | Active comparator | Other: BFDThe investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip |
| 2 BTX A | Active comparator | Other: BTX AInjected with BTX-A in the left lateral position; anesthesia was not required |
| 3: PDPR | Active comparator | Procedure: PDPRInner half of puborectalis sling was divided on each side by using a scalpel NO |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60patients fulfilled Rome II criteria for functional constipation
- All patients were unresponsive to laxatives or enema use
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFDAlso: BIOFEEDBACK RETRAININGThe investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip | Other | 1:BFD |
| PDPRAlso: PARTIAL DIVISION OF PUBORECTALISA 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 | Procedure or surgery | 3: PDPR |
| BTX AAlso: BOTILINUM TOXINA 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 | 2 BTX A |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 18719924Farid 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 publication: PubMed 19039596Farid 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 publication: PubMed 10733120Maria 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 publication: PubMed 3416122Kamm 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 publication: PubMed 8674369Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayman elnakeeb, MD principal investigator
MANSUORA UNIVERSITY HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFD, PDPR and BTX A in people with Obstructed Defecation and Anismus, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735605, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.