Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000802202
Ethics application status
Approved
Date submitted
9/09/2009
Date registered
16/09/2009
Date last updated
16/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between perineal and anal repair of rectocele in obstructed defecation patients
Scientific title
Randomized Controlled Trial evaluating the effect of Perineal versus Anal Repairs of Rectocele on functional score, symptom improvement and sexual function in patients with Obstructed Defecation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructed defecation due to rectocele 243704 0
Condition category
Condition code
Surgery 239968 239968 0 0
Surgical techniques
Oral and Gastrointestinal 239991 239991 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
multiparous females women with obstructed defecation due to rectocele will be randomly allocated into three groups: transperineal repair with levatorplasty (TPR-LP); transperineal repair without levatorplasty (TPR); and transanal repair (TAR. The study includes defecographic assessment, anal manometry, and score on a function questionnaire. Assessments will be done preoperatively and six months postoperatively.
In the transanal approach,a Hill-Ferguson retractor was inserted into the anal canal, and the anterior rectal wall was exposed. With a finger inserted in the vagina, the true borders of the rectocele were delineated. After submucosal infiltration of a 1:200000 adrenaline solution in saline, the mucosal flap in the whole area of the rectocele (starting 1 cm above the dentate line) was elevated and excised. Horizontal plication of the muscular layer was performed with 2/0 Vicryl sutures, and the continuity of the mucosa was restored with one row of interrupted 3/0 Vicryl sutures (half Delorme procedure). Rectal packing was not used, and normal feeding was allowed on the second day after the operation.
In the transperineal approach, a transverse incision was made in the perineum above the subcutaneous anal sphincter, and dissection was performed between the rectum and the vagina. Suturing of the rectal submucosal area was done with 3/0 Vicryl sutures. Then the deeper transverse or deeper perineal tissues were approximated to reinforce the rectovaginal septum, and to take tension off the first layer of sutures.
When levatorplasty was done, tissues of the perineal body, including the puborectalis muscle, were approximated in the midline to provide an additional layer of tissue between the vaginal and rectal wall and to reinforce the closure.
Each procedure takes about 45 - 60 minutes
Intervention code [1] 241242 0
Treatment: Surgery
Comparator / control treatment
Trans anal repair considered as control treatment
Control group
Active

Outcomes
Primary outcome [1] 240770 0
Resumption of normal function
Timepoint [1] 240770 0
6 months after surgery by questionnaires
Primary outcome [2] 240893 0
symptoms of obstruction during defecation and sexual function
Timepoint [2] 240893 0
6 months after surgery by questionnaires
Secondary outcome [1] 257444 0
Recurrence by examination at 3 months intervals
Timepoint [1] 257444 0
recurrence assesed once every 3 months for a year after surgery

Eligibility
Key inclusion criteria
multiparous females with rectocele
Minimum age
20 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with recurrent rectocele, diabetes, previous anal surgery, systemic steroid treatment, connective tissue disease, slow-transit constipation, compromised anal sphincter function, or abnormal thyroid function

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)
patients presented to outpatient clinic in our institute. allocation of treatment will be done by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2041 0
Egypt
State/province [1] 2041 0

Funding & Sponsors
Funding source category [1] 243616 0
Self funded/Unfunded
Name [1] 243616 0
Country [1] 243616 0
Egypt
Primary sponsor type
Individual
Name
Khaled Madbouly
Address
Mehatet el Raml, university of alexandria, faculty of medicine, department of surgery, alexandria. 21311
Country
Egypt
Secondary sponsor category [1] 237084 0
Hospital
Name [1] 237084 0
Mansoura University hospital
Address [1] 237084 0
Mansoura University, faculty of medicine, main square, mansoura, Egypt, 21326
Country [1] 237084 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243743 0
Alexandria committee
Ethics committee address [1] 243743 0
Mehatet el Raml, University of Alexandria, faculty of medicine, alexandria 21311
Ethics committee country [1] 243743 0
Egypt
Date submitted for ethics approval [1] 243743 0
Approval date [1] 243743 0
01/01/2004
Ethics approval number [1] 243743 0

Summary
Brief summary
Although functional outcome of surgical rectocele repair is considered successful in 70 to 90 percent of patients, it is a matter of debate which procedure is the most effective. This study was therefore designed to evaluate functional outcome of transperineal repair with and without levatorplasty versus transrectal repair of rectocele with obstructed defecation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30167 0
Address 30167 0
Country 30167 0
Phone 30167 0
Fax 30167 0
Email 30167 0
Contact person for public queries
Name 13414 0
Khaled madbouly
Address 13414 0
Mehatet el raml, Alex faculty of Medicine, university of alexandria, departement of surgery, alexandria, 21311
Country 13414 0
Egypt
Phone 13414 0
2034864416
Fax 13414 0
Email 13414 0
[email protected]
Contact person for scientific queries
Name 4342 0
khaled madbouly
Address 4342 0
Mehatet el raml, Alex faculty of Medicine, university of alexandria, departement of surgery, alexandria, 21311
Country 4342 0
Egypt
Phone 4342 0
2034864416
Fax 4342 0
Email 4342 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.