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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
Scientific title
Pelvic organ prolapse suspension using ventral rectopexy versus stapled transanal rectal resection in treatment of obstructing defecation
Secondary ID [1] 282526 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perineal descent syndrome 289190 0
Obstructed defecation due to rectocele or Intussusception 306516 0
Condition category
Condition code
Surgery 289515 289515 0 0
Surgical techniques
Other 289516 289516 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
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 .
Intervention code [1] 287186 0
Treatment: Surgery
Intervention code [2] 287202 0
Treatment: Devices
Comparator / control treatment
Control group is having stapled transanal rectal resection using Mini Contour stapler. .
Control group
Active

Outcomes
Primary outcome [1] 289612 0
correction of the obstructed defecation symptoms such as sense of incomplete evacuation or difficult evaculation using modified obstructed-defecation syndrome questionnaire (MODS)
Timepoint [1] 289612 0
6 months
Primary outcome [2] 289613 0
correction of the fecal incontinence symptoms using wexner incontinence score
Timepoint [2] 289613 0
6 months
Secondary outcome [1] 302858 0
quality of life score using SF-36 Quality of Life Questionnaire
Timepoint [1] 302858 0
6 months

Eligibility
Key inclusion criteria
elderly males or females
Perineal descent
symptoms of obstrucred defecation and/or fecal incontinence
Minimum age
70 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no exclusions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5087 0
Egypt
State/province [1] 5087 0
Alexandria

Funding & Sponsors
Funding source category [1] 287306 0
University
Name [1] 287306 0
University of Alexandria
Address [1] 287306 0
faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
Country [1] 287306 0
Egypt
Primary sponsor type
University
Name
University of Alexandria
Address
faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
Country
Egypt
Secondary sponsor category [1] 286058 0
Hospital
Name [1] 286058 0
Gamal abd el Nasser Hospital
Address [1] 286058 0
El Horria avenue- Ibrahimia- Alexandria, Egypt 21333
Country [1] 286058 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289282 0
University of Alexandria ethics committee
Ethics committee address [1] 289282 0
faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321
Ethics committee country [1] 289282 0
Egypt
Date submitted for ethics approval [1] 289282 0
28/04/2013
Approval date [1] 289282 0
18/05/2013
Ethics approval number [1] 289282 0

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)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40162 0
A/Prof Khaled Madbouly
Address 40162 0
faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
Country 40162 0
Egypt
Phone 40162 0
+2034802375
Fax 40162 0
Email 40162 0
kmadbouly@gmail.com
Contact person for public queries
Name 40163 0
A/Prof Khaled Madbouly
Address 40163 0
faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
Country 40163 0
Egypt
Phone 40163 0
+2034802375
Fax 40163 0
Email 40163 0
kmadbouly@gmail.com
Contact person for scientific queries
Name 40164 0
A/Prof Khaled Madbouly
Address 40164 0
faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321
Country 40164 0
Egypt
Phone 40164 0
+2034802375
Fax 40164 0
+2034802375
Email 40164 0
kmadbouly@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results