Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000947707p
Ethics application status
Submitted, not yet approved
Date submitted
28/06/2022
Date registered
5/07/2022
Date last updated
5/07/2022
Date data sharing statement initially provided
5/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy and the risk of prolapse occurrence – a randomised controlled trial
(REATTACH)
Scientific title
Investigating pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy for patient outcomes and risk of prolapse occurrence - a randomised controlled trial (REATTACH)
Secondary ID [1] 307448 0
nil known
Universal Trial Number (UTN)
Trial acronym
REATTACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterovaginal prolapse 326827 0
Condition category
Condition code
Surgery 324040 324040 0 0
Other surgery
Reproductive Health and Childbirth 324073 324073 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consistent with our standard technique of hysterectomy, gynaecological surgeons commence the exposure of the uterosacrals by developing the medial pararectal space of Okabayashi. By this stage the lateral pararectal space of Latzko already has already been developed, ureters identified and lysed if necessary, and uterine vessels secured at the origin of the internal iliacs. The ureter is identified separating these two potential spaces, with the medial dissection carried to expose the uterosacral through its entire extent, especially the junction of the upper and middle thirds. The inferior hypogastric nerve is identified and preserved whenever possible. If excision of deep infiltrating endometriotic deposits make the preservation of parts of the uterosacrals untenable, a proximal anchor towards the upper third of the ligament is chosen. A marking stitch may be appropriate in such cases for easy identification. The hysterectomy will then proceed per usual methods, including possible removal of associated adnexae. Uniformity of surgery will be ensured by a single surgical team performing all surgeries.

For patients that are randomised to the high uterosacral suspension arm, following the hysterectomy ensuring adequate “pedicalisation” of the uterine vessels, the assistant places the uterosacral ligament ligament under stretch by lifting the vaginal angle. A 0 Prolene D7580 on a 26 mm CT2 needle is cut to 30 cm length (shorter if 2 separate suture packs used). The uterosacral ligament is plicated in an inside-out, outside-in fashion, always commencing within the medial rectal space with the ureter coursing laterally in view. This suture is then driven through the bulky attachment of the uterosacral to the peri-cervical ring. The next bite is taken lateral to the vaginal edge and medial to the uterine pedicle ensuring that the Prolene does not enter the vaginal mucosa throughout its entire course. This also prevents bunching or infolding of the vault edges which can make vault closure tricky. The suture carried anteriorly is then robustly anchored to the pubovesical fascia and then makes it way posteriorly past the anchor point to the uterosacral at the pericervical ring to incorporate a robust bite through the rectovaginal fascial attachment to this structure. Following this, the suture is tied intracorporeally with 5 squared knots. The procedure is then repeated on the other side. This will then be followed by vaginal closure of the vault is carried out using V-Loc 90 suture (Covidien, Dublin, Ireland) in 2 layers taking care to incorporate the pubovesical fascia and the rectovaginal fascia which is contiguous with the vaginal vault.
The whole hysterectomy will take about 2 hours, the uterosacral suspension procedure will take approximately 10 more minutes.
Technique will be documented in the operative notes recorded on electronic medical records (EMR)
Intervention code [1] 323901 0
Treatment: Surgery
Comparator / control treatment
For patients that are randomised and assigned to the standard cuff closure group without the high uterosacral suspension, they will undergo a standard 2-layer laparoscopic closure of the colpotomy incorporating the pubovesical fascia, the rectovaginal fascia and distal ends of the uterosacral ligaments using a continuous 2-0 V-Loc 90 suture.
Technique will be documented in the operative notes recorded on electronic medical records (EMR)
The whole hysterectomy will take about 2 hours.
Control group
Active

Outcomes
Primary outcome [1] 331830 0
- Quantitative C point;
(C point is part of POP Q (pelvic organ prolapse quantification) assessment, which is the distance the cervix (or vault in a post hysterectomy setting) from the hymenal remnant). Data collected at different time points will be stored on a data collection spreadsheet stored on REDCap at Townsville University Hospital. REDCap (Research Electronic Data capture) is a secure, web-based software platform about the study.
Timepoint [1] 331830 0
post surgery, 6 and 12 months (primary endpoint)
Primary outcome [2] 331845 0
- Change in sexual function assessed using the PISQ-12 questionnaire;
Timepoint [2] 331845 0
Baseline (pre-surgery) and 3 months post surgery
Primary outcome [3] 331846 0
- Change in symptom distress from pelvic floor dysfunction assessed using the PFDI - 20;
Timepoint [3] 331846 0
Baseline (pre-surgery) and 3 months post surgery
Secondary outcome [1] 411328 0
length of operative time through an audit of operative notes by obtaining surgery start and end times
Timepoint [1] 411328 0
immediately post-surgery
Secondary outcome [2] 411384 0
presence of complications such as rates of urinary retention, urinary tract infection, bladder injury, paraesthesia. This data will be obtained through an audit of operative notes and will be asked to patients in the phonemail for their routine 3 months followup in going through their questionnaire
Timepoint [2] 411384 0
3 months post surgery

Eligibility
Key inclusion criteria
• Patients must be 18 years of age or older
• Patients must be able to provide informed consent
• Preoperative inclusion criteria include: C point not past the hymenal remnant, i.e. C point at point 0 at Valsalva
• Patients with no prolapse symptoms
• A Pelvic ultrasound scan (USS) in the last 6 months from booking of procedure to show that size of uterus is less than or equal to 300cc
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women undergoing a total laparoscopic hysterectomy for malignancy
• Women with a history of pre-existing pelvic organ prolapse, patients with cervical apical descent past the hymen, grade 2 uterocervical pelvic organ prolapse will be excluded
• Women with serious medical conditions who are unable to perform a Valsalva manoeuvre
• Non-English-speaking patients (unless access to a qualified interpreter is available during the full duration of the study)
• Size of uterus on ultrasound scan greater than 300cc
• Age greater than 75 years old
• BMI greater than 45
• Pathology obliterating the pouch of Douglas
• Stage 4 endometriosis
• Anticipated geographic relocation within the first 12 months following surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
double blinding through sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via permuted block randomisation, to the intervention or control group. The 66 patients will be randomised to their study allocation prior to surgery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Postoperative change in c point was used in the sample size calculation as the primary end point. The sample size was calculated based on a pilot study where there was a total of 50 patients recruited, in accounting of 30% attrition rate, the number of patients needed to be recruited in each arm was calculated to be 33. Statistical analysis will be performed using STATA (version 16; StataCorp LP; College Station, Tx). Continuous variables will be summarized using mean and standard deviation with parametric data and using median and interquartile range with non-parametric data. Categorical variables will be summarized using frequencies and percentages. Continuous variables were tested for normal distribution and subsequently analysed using either the unpaired Student’s t test or Mann-Whitney U test where appropriate. Categorical variables were analysed using the chi-square test or Fisher’s exact test, where appropriate. Values of p<0.05 were considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22645 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 37920 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 311723 0
Hospital
Name [1] 311723 0
Townsville University Hospital
Country [1] 311723 0
Australia
Primary sponsor type
Hospital
Name
Townsville University Hospital
Address
Townsville University Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 313182 0
None
Name [1] 313182 0
none
Address [1] 313182 0
none
Country [1] 313182 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311168 0
Ethics Committee Townsville Hospital
Ethics committee address [1] 311168 0
Ethics committee country [1] 311168 0
Australia
Date submitted for ethics approval [1] 311168 0
28/06/2022
Approval date [1] 311168 0
Ethics approval number [1] 311168 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120190 0
Dr Inge Putri
Address 120190 0
Townsville University Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 120190 0
Australia
Phone 120190 0
+61 7 4433 3693
Fax 120190 0
Email 120190 0
[email protected]
Contact person for public queries
Name 120191 0
Inge Putri
Address 120191 0
Townsville University Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 120191 0
Australia
Phone 120191 0
+61 7 4433 3693
Fax 120191 0
Email 120191 0
[email protected]
Contact person for scientific queries
Name 120192 0
Inge Putri
Address 120192 0
Townsville University Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 120192 0
Australia
Phone 120192 0
+61 7 4433 3693
Fax 120192 0
Email 120192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
demographics and outcomes
When will data be available (start and end dates)?
Data will be available from conclusion of the study, for 5 years after conclusion of the study
Available to whom?
to patients who wishes to find out outcomes of the study
Available for what types of analyses?
closed analysis
How or where can data be obtained?
through contacting research project team by email address or phone
[email protected]
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16487Study protocol    384283-(Uploaded-28-06-2022-11-38-09)-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.