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Trial registered on ANZCTR
Registration number
ACTRN12613000606785
Ethics application status
Approved
Date submitted
20/05/2013
Date registered
28/05/2013
Date last updated
7/05/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Pelvic organ prolapse suspension and stapled transanal rectal resection in treatment of obstructing defecation
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Scientific title
Pelvic organ prolapse suspension using ventral rectopexy versus stapled transanal rectal resection in treatment of obstructing defecation
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Secondary ID [1]
282526
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
perineal descent syndrome
289190
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Obstructed defecation due to rectocele or Intussusception
306516
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Condition category
Condition code
Surgery
289515
289515
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0
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Surgical techniques
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Other
289516
289516
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Laparoscopic pelvic organ prolapse suspension by prolene mesh fixed to the anterior wall of rectum in one group of patients. Procedure duration approximately 120 minutes. The mesh will remain in situ forever.
A second new intervention group is added which receive stapled transanal rectal resection using Mini Contour stapler .
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Intervention code [1]
287186
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Treatment: Surgery
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Intervention code [2]
287202
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Treatment: Devices
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Comparator / control treatment
Control group is having stapled transanal rectal resection using Mini Contour stapler. .
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Control group
Active
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Outcomes
Primary outcome [1]
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correction of the obstructed defecation symptoms such as sense of incomplete evacuation or difficult evaculation using modified obstructed-defecation syndrome questionnaire (MODS)
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Assessment method [1]
289612
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Timepoint [1]
289612
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6 months
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Primary outcome [2]
289613
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correction of the fecal incontinence symptoms using wexner incontinence score
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Assessment method [2]
289613
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Timepoint [2]
289613
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6 months
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Secondary outcome [1]
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quality of life score using SF-36 Quality of Life Questionnaire
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Assessment method [1]
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
elderly males or females
Perineal descent
symptoms of obstrucred defecation and/or fecal incontinence
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Minimum age
70
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
no exclusions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2013
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
75
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Final
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Recruitment outside Australia
Country [1]
5087
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Egypt
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State/province [1]
5087
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Alexandria
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Funding & Sponsors
Funding source category [1]
287306
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University
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Name [1]
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University of Alexandria
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Address [1]
287306
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faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
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Country [1]
287306
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Egypt
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Primary sponsor type
University
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Name
University of Alexandria
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Address
faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
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Country
Egypt
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Gamal abd el Nasser Hospital
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Address [1]
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El Horria avenue- Ibrahimia- Alexandria, Egypt 21333
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Country [1]
286058
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Egypt
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289282
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University of Alexandria ethics committee
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Ethics committee address [1]
289282
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faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
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Ethics committee country [1]
289282
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Egypt
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Date submitted for ethics approval [1]
289282
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28/04/2013
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Approval date [1]
289282
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18/05/2013
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Ethics approval number [1]
289282
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Summary
Brief summary
In the normal individual the anorectal angle is a factor in maintaining faecal continence. If intra-abdominal pressure is transmitted to the anterior rectal wall, for example during coughing or sneezing, mucosa will be forced onto the upper part of the anal canal to form a flap-valve.
In patients with the descending perineum syndrome, the anorectal angle is disrupted because it lies at a lower level than normal and the patient is complaining of feeling of incomplete evacuation and straining that lead to rectorectal intussusception and/ or rectocele
Correction of rectorectal intussusception and/ or rectocele can be done by stapled transanal rectal resection or abdominally by pelvic organ suspension using ventral rectopexy.
Pelvic organ prolapsed suspension using ventral rectopexy and stapled transanal rectal resection can solve the anatomical problem of obstructed defecation, however no data which would have better results in multiparous females .
Purpose of the study is to compare the outcome of laparoscopic ventral rectopexy versus stapled transanal rectal resection in obstructed defecation in elderly. Our hypothesis is that Laparoscopic ventral rectopexy will have better results as in these patients there is usually weakness of pelvic floor which is not supported in case of stapled transanal rectal resection
Patients and Methods:
80 patients with descending perineal syndrome and obstructed defecation above 70 years of age will be treated by laparoscopic ventral mesh rectopexy or stapled transanal rectal resection by random choice ( two equal groups)
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
40162
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A/Prof Khaled Madbouly
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Address
40162
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faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
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Country
40162
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Egypt
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Phone
40162
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+2034802375
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Fax
40162
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Email
40162
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[email protected]
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Contact person for public queries
Name
40163
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A/Prof Khaled Madbouly
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Address
40163
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faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
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Country
40163
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Egypt
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Phone
40163
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+2034802375
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Fax
40163
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Email
40163
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[email protected]
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Contact person for scientific queries
Name
40164
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A/Prof Khaled Madbouly
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Address
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faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
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Country
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Egypt
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Phone
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+2034802375
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Fax
40164
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+2034802375
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Email
40164
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Laparoscopic Ventral Rectopexy Versus Stapled Transanal Rectal Resection for Treatment of Obstructed Defecation in the Elderly: Long-term Results of a Prospective Randomized Study.
2019
https://dx.doi.org/10.1097/DCR.0000000000001256
N.B. These documents automatically identified may not have been verified by the study sponsor.
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