Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000830796
Ethics application status
Approved
Date submitted
9/05/2022
Date registered
14/06/2022
Date last updated
15/05/2023
Date data sharing statement initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Vaginal Hysterectomy and Manchester Procedure for uterine prolapse
Scientific title
A prospective cohort study for success of vaginal hysterectomy with vault suspension compared to Manchester-Fothergill Procedure for utero-vaginal prolapse
Secondary ID [1] 307046 0
none
Universal Trial Number (UTN)
Trial acronym
The VaMP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 326194 0
uterovaginal prolapse 326195 0
Condition category
Condition code
Surgery 323495 323495 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As is usual practice, participants electing to undergo pelvic organ prolapse surgery would be offered uterine preserving surgery such as Manchester procedure (MP) as well as hysterectomy. This is done at a face to face consult with a Urogynaecologist or trainee under the supervision of a Urogynaecologist. After being provided with verbal and written information, patients will choose which procedure they will undergo to address their prolapse. All patients who choose either a MP will be offered enrolment in the study. The Manchester repair will be performed by a Urogynaecologist and/or Urogynaecology subspecialty trainee. The whole procedure would take about 1.5hrs including a cystoscopy at completion.
Intervention code [1] 323507 0
Treatment: Surgery
Comparator / control treatment
As is usual practice, participants electing to undergo pelvic organ prolapse surgery would be offered uterine preserving surgery such as Manchester procedure (MP) as well as hysterectomy. This is done at a face to face consult with a Urogynaecologist or trainee under the supervision of a Urogynaecologist. After being provided with verbal and written information, patients will choose which procedure they will undergo to address their prolapse. All patients who choose a VH will be offered enrolment in the study. The VH will be performed by a Urogynaecologist and/or Urogynaecology subspecialty trainee and will include a vault suspension procedure. The choice of procedure will be at the discretion of the surgeon. The whole procedure would take about 1.5hrs including a cystoscopy at completion.
Control group
Active

Outcomes
Primary outcome [1] 331258 0
To assess the recurrence of prolapse after MP versus vaginal hysterectomy (VH) at 6 months, 2 years, 5 years defined as no recurrent prolapse requiring repeat prolapse surgery or pessary assessed by absence of bulge sensation as reported by the patient.
Timepoint [1] 331258 0
6 months (primary time point), 2 years, 5 years post surgery
Secondary outcome [1] 409331 0
Anatomical outcomes will be defined using the Pelvic Organ Prolapse Quantification System (POPQ)
Timepoint [1] 409331 0
6 months, 2 years, 5 years post surgery
Secondary outcome [2] 409625 0
Subjective outcome defined as absence of vaginal bulge reported by the patient at 6 months, 2 years, 5 years post surgery.
Timepoint [2] 409625 0
6 months, 2 years, 5 years post surgery
Secondary outcome [3] 409626 0
Reoperation defined as repeat surgery including for complications or stress urinary incontinence using patient medical records and patient history at follow up appointments.
Timepoint [3] 409626 0
6 months, 2 years, 5 years post surgery.
Secondary outcome [4] 409627 0
Patient satisfaction determined by Patient Global Impression of Improvement (PGI-I)
Timepoint [4] 409627 0
6 months, 2 years, 5 years post surgery
Secondary outcome [5] 409628 0
Complications using Clavien-Dindo according to medical record and patient follow up
Timepoint [5] 409628 0
6 months, 2 years, 5 years post surgery
Secondary outcome [6] 409630 0
Blood loss (mL) using operation report
Timepoint [6] 409630 0
Immediate post operative period
Secondary outcome [7] 409911 0
Patient reported symptoms using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6)
Timepoint [7] 409911 0
6 months, 2 years, 5 years post surgery
Secondary outcome [8] 409912 0
Patient quality of life using the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Timepoint [8] 409912 0
6 months, 2 years, 5 years post surgery
Secondary outcome [9] 409913 0
Patient quality of life using the Urinary Distress Inventory, Short Form (UDI-6)
Timepoint [9] 409913 0
6 months, 2 years, 5 years post surgery
Secondary outcome [10] 409914 0
Patient reported symptoms using the Colorectal-Anal Distress Inventory-8 (CRADI-8)
Timepoint [10] 409914 0
6 months, 2 years, 5 years post surgery
Secondary outcome [11] 409915 0
Patient reported symptoms using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12).
Timepoint [11] 409915 0
6 months, 2 years, 5 years post surgery
Secondary outcome [12] 409916 0
Length of hospital stay according to medical record
Timepoint [12] 409916 0
Immediate post operative period
Secondary outcome [13] 409917 0
Analgesia requirements according to medical record
Timepoint [13] 409917 0
Immediate post operative period

Eligibility
Key inclusion criteria
Inclusion Criteria
All participants between the ages of 18-80 with symptomatic stage I-III pelvic organ prolapse (POP) requesting surgery including hysterectomy, capable of providing informed consent and able to return for follow up.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Any previous prolapse surgery
Previous surgery in the treatment area in the last year.
Systemic steroids use within the last 3 months
Pelvic organ prolapse (POP) > stage 3 according to pelvic organ prolapse quantification system
Past history of prolapse surgery with transvaginal mesh
Serious systemic disease or any chronic condition that could interfere with study compliance
Uterine pathology that would make uterine preservation inappropriate
Co-morbidities or surgical history that would make a particular approach inappropriate
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Participants will be allocated to either the Vaginal Hysterectomy or Manchester Procedure groups depending upon their preference for either procedure.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes were compared with Pearson chi squared test for categorical data and Student t test or Wilcoxon signed rank Test for continuous data as appropriate. 2 sided 95% confidence intervals will be used. Regression analysis will be performed as appropriate.

Pre-treatment & post-treatment changes in patient reported outcomes were analysed using Analaysis of covariance (ANCOVA) to adjust for baseline data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
5/07/2022
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
31/05/2030
Actual
Sample size
Target
202
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22314 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 22316 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 22317 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 37475 0
3084 - Heidelberg
Recruitment postcode(s) [2] 37478 0
3144 - Malvern
Recruitment postcode(s) [3] 37477 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 311357 0
Hospital
Name [1] 311357 0
Mercy Hospital
Country [1] 311357 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital
Address
163 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 312754 0
Hospital
Name [1] 312754 0
Monash Hospital - Moorabin
Address [1] 312754 0
Centre Rd, Bentleigh East, VIC 3165
Country [1] 312754 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310850 0
Mercy Hospital
Ethics committee address [1] 310850 0
163 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 310850 0
Australia
Date submitted for ethics approval [1] 310850 0
Approval date [1] 310850 0
22/04/2022
Ethics approval number [1] 310850 0
2022-005

Summary
Brief summary
The Manchester Procedure (MP) and vaginal hysterectomy with vault suspension (VH) are two surgical options for the treatment of pelvic organ prolapse (POP). The evidence of benefit is currently limited to one prospective trial and several retrospective reviews. The two procedures have been studied in isolation though much more data exists for VH.

Recent Danish registry data in a matched cohort study (n=590) suggested prolapse outcomes after Manchester repair were better than those after vaginal hysterectomy with vault suspension.

In addition to the question of effectiveness of the procedure, the economic benefits of MP versus VH have been studied in the international literature. Costs for the first 20 months after the operation were higher in the VH group when analyzing the primary operation only, and higher still when including subsequent activities within 20 months.

Given the MP is performed far less frequently in Australia, presumably due to patient selection and surgeon preference, there is a benefit for the local and international community to learn more about the differences in outcome between the procedures. Local data that shows equivalent outcomes may encourage increased uptake of the procedure which may lead to health gains for the patient and improved economic outcomes for hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119086 0
Dr Lore Schierlitz
Address 119086 0
Mercy Hospital
163 Studley Rd, Heidelberg VIC 3084
Country 119086 0
Australia
Phone 119086 0
+61 408118323
Fax 119086 0
Email 119086 0
lschierlitz@mercy.com.au
Contact person for public queries
Name 119087 0
Dr Victoria Buckley
Address 119087 0
Monash Hospital
823-865 Centre Rd. Bentleigh East VIC 3165
Country 119087 0
Australia
Phone 119087 0
+61 404161466
Fax 119087 0
Email 119087 0
victoria.buckley@monashhealth.org
Contact person for scientific queries
Name 119088 0
Dr Lore Schierlitz
Address 119088 0
Mercy Hospital
163 Studley Rd, Heidelberg VIC 3084
Country 119088 0
Australia
Phone 119088 0
+61 408118323
Fax 119088 0
Email 119088 0
lschierlitz@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The researchers who contribute their study data will review but not widely available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15929Study protocol    384007-(Uploaded-04-05-2022-10-42-19)-Study-related document.docx
15930Ethical approval    384007-(Uploaded-09-05-2022-10-24-12)-Study-related document.pdf
15931Informed consent form    384007-(Uploaded-04-05-2022-10-42-32)-Study-related document.docx



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.