Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000427572
Ethics application status
Approved
Date submitted
30/09/2014
Date registered
5/05/2015
Date last updated
5/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study of laparoscopic versus abdominal sacral colpopexy in women with Grade III or IV uterovaginal prolapse
Scientific title
Comparative study of laparoscopic versus abdominal sacral colpopexy in women with Grade III or IV uterovaginal prolapse evaluating operating room time, estimated blood loss , inpatient days, and recurrence
Secondary ID [1] 285418 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterovaginal prolapse 293164 0
Condition category
Condition code
Reproductive Health and Childbirth 293443 293443 0 0
Other reproductive health and childbirth disorders
Surgery 293645 293645 0 0
Surgical techniques
Renal and Urogenital 293646 293646 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical Examination: preoperative physical examination will be performed in the supine position with the Valsalva maneuver. Genital prolapse will be staged according to the pelvic organ prolapse quantification (POP-Q) as described by the International Continence Society by a gynaecologist with consistent experience.
Pre-operative Pap smear.
Preoperative urodynamic study (cystometry) .
All operations will take place under general anaesthesia in a lithotomy position with legs laid flat, with a Foley catheter in the bladder.
A retroperitoneal approach will be used in all cases. The posterior parietal peritoneum is incised vertically from the promontory to the vaginal apex, between the midline and the right ureter.
Dissection of the peritoneal covering of the back of the cervix or the vagina.
The presacral ligament is exposed in the midline over S1 by careful dissection avoiding injury to the median sacral vessels.
Monofilament polypropylene mesh (Prolene) mesh will be sutured to the ligament and the vagina.
Group A: (15 patient)
Where laparoscopic sacrocolpopexy will be done through 4 trocar ports with average duration of 100-200 min.
Intervention code [1] 290335 0
Treatment: Surgery
Comparator / control treatment
Group B:(15 patient)
Where abdominal sacrocolpopexy will be done through laparotomy with duration of 60-90 min.
Control group
Active

Outcomes
Primary outcome [1] 293263 0
duration of hospital stay
Timepoint [1] 293263 0
At hospital discharge
Primary outcome [2] 293460 0
recurrence of Uterovaginal prolapse
Timepoint [2] 293460 0
followup by POP-Q at 1, 3, 6, and 12 months post surgery.
Secondary outcome [1] 310692 0
Intra- and postoperative complications such as bladder , rectal injuries.
Timepoint [1] 310692 0
Intra-operatively and up to 24 hours post-operative.
Secondary outcome [2] 311099 0
quality of life by using SF-36 Quality of Life Questionnaire
Timepoint [2] 311099 0
quality of life will be assessed at 1,6,12 months postoperative
Secondary outcome [3] 311100 0
satisfaction by SF-36 Quality of Life Questionnaire and visual analogue bother score .
Timepoint [3] 311100 0
visual analogue score (VAS) score and questionnaire will be assessed at 1,6,12 months postoperative

Eligibility
Key inclusion criteria
1. Grade III or IV uterovaginal prolapse according to the pelvic organ prolapse quantification (POP-Q).
2. Uterine or vault prolapse .
3. Normal uterus and ovaries on ultrasound examination.
4. Normal menstrual bleeding pattern (if premenopausal).
5. Normal Pap smear.
Minimum age
30 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to give informed consent or to return for follows up.
2. Unable to undergo general anaesthesia.
3. Prior sacral colpopexy.
4. Patients presenting with lower grade prolapse.
5. Genuine stress incontinence.
6. Indication for hysterectomy

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
1/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6382 0
Egypt
State/province [1] 6382 0

Funding & Sponsors
Funding source category [1] 290023 0
Hospital
Name [1] 290023 0
el-shatby maternity university hospital
Country [1] 290023 0
Egypt
Primary sponsor type
University
Name
alexandria university, faculty of medicne
Address
15 port saeed street, alexandria ,22022
Country
Egypt
Secondary sponsor category [1] 288711 0
Individual
Name [1] 288711 0
ahmed samy el-agwany
Address [1] 288711 0
el-shatby maternity hospital,
15 port saeed street, alexandria ,22022
Country [1] 288711 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study was undertaken to compare laparoscopic and open sacral colpopexies for efficacy and safety.
This prospective randomized controlled study was conducted in the Gynecologic Department of El-Shatby Maternity Hospital , University of Alexandria in Egypt. It involved 30 women selected after fulfilling the criteria of inclusion into the study with informed consent to participate in the study. All patients in this study were randomly allocated into one of the two following groups: Group A: (15 patient) Where laparoscopic sacrocolpopexy was done. Group B :( 15 patient) Where abdominal (open) sacrocolpopexy was done.
Demographic and hospital data, complications, and follow-up visits were reviewed. Median follow-up was 12 months in the laparoscopic and open groups. Mean operating time was significantly greater in the laparoscopic versus open cohort, 70 minutes and 90 minutes, respectively . Estimated blood loss (84 mL vs 156 ml) and hospital stay (2 vs 1 day ) were significantly less in the laparoscopic group than the open group. Hospital stay was was significant less in laparoscopy versus open groeup (2 versus 4 days ). Demographic data , other perioperative data, quality of life assessment , subjective , objective cure rates , complications and reoperation rates were non-significant.
As a conclusion, Laparoscopic and open sacral colpopexies have comparable clinical outcomes. Although laparoscopic sacral colpopexy requires longer operating time, hospital stay and blood loss are significantly decreased. Postoperatively overall quality of life and sexual quality showed significant improvement .The subjective cure rate was 90% , the objective cure rate (no prolapse in any compartment) was 100%.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51774 0
Dr ahmed samy el-agwany
Address 51774 0
Department of Obstetrics and Gynecology,
El-shatby maternity university hospital,
Faculty of Medicine, Alexandria University, Alexandria, Egypt
15 portsaeed street, alexandria ,22022
Country 51774 0
Egypt
Phone 51774 0
+201228254247
Fax 51774 0
Email 51774 0
ahmedsamyagwany@gmail.com
Contact person for public queries
Name 51775 0
Dr ahmed samy el-agwany
Address 51775 0
Department of Obstetrics and Gynecology,
El-shatby maternity university hospital,
Faculty of Medicine, Alexandria University, Alexandria, Egypt
15 portsaeed street, alexandria ,22022
Country 51775 0
Egypt
Phone 51775 0
+201228254247
Fax 51775 0
Email 51775 0
ahmedsamyagwany@gmail.com
Contact person for scientific queries
Name 51776 0
Dr ahmed samy el-agwany
Address 51776 0
Department of Obstetrics and Gynecology,
El-shatby maternity university hospital,
Faculty of Medicine, Alexandria University, Alexandria, Egypt
15 port saeed street, alexandria ,22022
Country 51776 0
Egypt
Phone 51776 0
+201228254247
Fax 51776 0
Email 51776 0
ahmedsmayagwany@gmail.com

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Results publications and other study-related documents

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