Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000748617
Ethics application status
Approved
Date submitted
28/10/2005
Date registered
16/11/2005
Date last updated
16/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of laparoscopic resection rectopexy compared with fixation rectopexy for rectal prolapse
Scientific title
Randomised controlled trial of laparoscopic resection rectopexy compared with fixation rectopexy for rectal prolapse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Full thickness rectal prolapse 900 0
Condition category
Condition code
Oral and Gastrointestinal 968 968 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic resection rectopexy
Intervention code [1] 741 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic fixation rectopexy
Control group
Active

Outcomes
Primary outcome [1] 1286 0
Constipation
Timepoint [1] 1286 0
Primary outcome [2] 1287 0
Incontinence
Timepoint [2] 1287 0
Primary outcome [3] 1288 0
Quality of life
Timepoint [3] 1288 0
Secondary outcome [1] 2312 0
Post-operative pain
Timepoint [1] 2312 0
Secondary outcome [2] 2313 0
Time to return of bowel function
Timepoint [2] 2313 0
Secondary outcome [3] 2314 0
Post-operative morbidity
Timepoint [3] 2314 0
Secondary outcome [4] 2315 0
Length of stay
Timepoint [4] 2315 0
Secondary outcome [5] 2316 0
Recurrence
Timepoint [5] 2316 0
At 12 months

Eligibility
Key inclusion criteria
All adult patients attending participating surgeons for management of full thickness rectal prolapse and who are candidates for abdominal surgery will be eligible to participate.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are cognitively impaired or otherwise unable to give informed consent, those who require concomitant abdominal surgery and those considered unsuitable for laparoscopic surgery will be excluded. In addition, patients who are considered ineligible for fixation rectopexy on the basis of severe pre-operative constipation will be excluded at the discretion of their surgeon.

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)
Sealed opaque envelopes that are numerically listed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated - SAS.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
blind outcome assessment
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1066 0
Self funded/Unfunded
Name [1] 1066 0
Country [1] 1066 0
Primary sponsor type
Hospital
Name
Surgical Outcomes Research Centre - based in Royal Prince Alfred Hospital.
Address
Country
Australia
Secondary sponsor category [1] 928 0
None
Name [1] 928 0
None
Address [1] 928 0
Country [1] 928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2369 0
RPAH
Ethics committee address [1] 2369 0
Ethics committee country [1] 2369 0
Australia
Date submitted for ethics approval [1] 2369 0
Approval date [1] 2369 0
Ethics approval number [1] 2369 0

Summary
Brief summary
Rectal prolapse is a common and socially debilitating condition for which treatment is surgical. This trial will compare two procedures, namely laparoscopic resection rectopexy and laparoscopic fixation rectopexy, in order to determine which has the better short and long term outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35632 0
Address 35632 0
Country 35632 0
Phone 35632 0
Fax 35632 0
Email 35632 0
Contact person for public queries
Name 9930 0
Professor Michael Solomon
Address 9930 0
Surgical Outcomes Reseach Centre
PO Box M157
Missenden Rd
Camperdown NSW 2050
Country 9930 0
Australia
Phone 9930 0
+61 2 95197576
Fax 9930 0
+61 2 95191806
Email 9930 0
[email protected]
Contact person for scientific queries
Name 858 0
Sr Christine Merlino
Address 858 0
Colorectal Research Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 858 0
Australia
Phone 858 0
+61 2 95197576
Fax 858 0
Email 858 0
[email protected]

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
No additional documents have been identified.