Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001192673
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
17/11/2023
Date last updated
17/11/2023
Date data sharing statement initially provided
17/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing pelvic organ prolapse surgery in women with or without graft made from blood
Scientific title
Evaluating the surgical success rate of native tissue vaginal repair with or without autologous blood graft augmentation for pelvic organ prolapse: A randomised controlled trial
Secondary ID [1] 310175 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 330760 0
Condition category
Condition code
Renal and Urogenital 327592 327592 0 0
Other renal and urogenital disorders
Surgery 328322 328322 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: autologous graft
If a patient is randomised to "intervention group", she will undergo native tissue repair surgery [by two gynaecologists] with an autologous graft to augment the repair of the pelvic organ prolapse. Immediately before surgery, the experimental treatment involves drawing up 40mls of the patient's own blood for processing the autologous graft; this graft will be prepared in the operating theatre and produced at the time of surgery, which takes 40-60 minutes, and then be sutured or glued to the underlying connective tissue during prolapse repair surgery.

In the operating theatre room, the patient will be under a general anaesthesia during surgery. The conventional native tissue vaginal repair will be performed and then the autologous graft will be placed onto the prolapse repair site for augmentation. The vaginal skin is closed after this layer. At the completion of surgery, a vaginal pack and in-dwelling catheter will be placed until the next morning.

Adherence of intervention can be review of surgical record after the surgery and review of the patient and her records at each followup, at six weeks, six months, and 12 months.
Intervention code [1] 326569 0
Treatment: Other
Comparator / control treatment
Control group: conventional pelvic organ prolapse (POP) surgery
If a patient is randomised to "control group", they will undergo the conventional vaginal prolapse repair surgery [by two gynaecologists]. The surgery will be the same as intervention group, except that there is no graft created. At completion of surgery, a vaginal pack and in-dwelling catheter will be placed until the next morning.

In both groups, post-op care will be the same. Routine postoperative instructions will be provided regarding advice on physical activity progression, regular bowel habit, and abstinence of intercourse for 6wks. Patients will be discharged with an oral antibiotic if required. Follow-up will be at one week which is tele-consult and face-to-face at 6 weeks, 6 months, and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 335428 0
The primary outcome is the anatomical success rate of pelvic organ prolapse at one-year post-op, based on the change from baseline in pelvic organ prolapse quantification (POPQ) staging and at the 12-month follow-up visit. Success is defined as a decrease of 1 or more in POPQ stage at 12 months from baseline, with no reoperation for anterior and posterior vaginal wall prolapse. Participants with either no change in POPQ from baseline, or an increase, will be designated as failures.
Timepoint [1] 335428 0
12-month post-op follow-up visit
Secondary outcome [1] 424496 0
Quality of Life (QOL) as assessed by total score of the Australian pelvic floor questionnaire (APFQ), which is a validated tool that integrates bladder, bowel, prolapse, and sexual function. Higher scores in each domain suggest greater QOL impairment. Patients will be asked to fill out APFQ questionnaires at baseline and each follow-up visit.
Timepoint [1] 424496 0
at 6 weeks, 6 months, and 12 months post-op.
Secondary outcome [2] 424497 0
Minor and major complication rates, infection, severe bleeding (blood loss of 500mls), urinary tract infection, wound breakdown, graft rejection, unplanned return to theatre, urinary retention treated with catheter, visceral injury, venous thromboembolism and pulmonary embolism. These will be assessed as a composite outcome. This will be assess by clinician review, Australian Pelvic Floor Questionnaire (APFQ), review of patient medical record
Timepoint [2] 424497 0
Post-op, 6 weeks, 6 months, and 12 months postop
Secondary outcome [3] 424498 0
Pain score postop by pain visual analogue scale and need for analgesia will be compared in both groups.
Timepoint [3] 424498 0
Post-op (within 24 hours post-surgery)
Secondary outcome [4] 427203 0
pain score by visual analogue scale by review of medical records
Timepoint [4] 427203 0
at baseline, 6 weeks, 6 months, 12 months post-op
Secondary outcome [5] 427204 0
need for analgesia by review of medical records
Timepoint [5] 427204 0
at baseline, 6 weeks, 6 months, 12 months postop

Eligibility
Key inclusion criteria
Participants will be considered eligible for this study if they:

1. Are female patients over the age of 18
2. Have been formally diagnosed with pelvic organ prolapse quantification (POPQ) stage 2 of anterior and or posterior compartment with or without apical prolapse, defined as c -1 (cervix or vaginal cuff 1 cm above hymen) or less.
3. Understand the conditions of the study fully and are willing to participate for the length of the study in its entirety;
4. Are capable of giving informed consent to their participation in the study.
Minimum age
19 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patients will be deemed unsuitable for inclusion:

Patients currently suffering any untreated gynaecological cancers.
Patients with autoimmune disorders requiring anti-platelet medication (antiplatelet drugs weaken the regenerative capacity of autologous blood products and reduces the quality of the graft)
Patients who are immunocompromised (e.g. lymphoma, AIDS) or have uncontrolled malignant disease.
Patients on anti-platelet treatment. Using anticoagulants and NSAIDs is not allowed three weeks before and after surgery due to their interference with the scaffold formation.
Patients who have a mental disability leading to their inability to consent.
Patients who are pregnant.
Patients who are uncooperative, known to miss appointments, are unlikely to follow medical instructions, or unable to attend regular scheduled visits.

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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A statistical analysis plan will be prepared prior to data lock.

In general:
A p-value of 0.05 is selected to assess statistical significance.
Means and standard deviations (SD’s) will be calculated for continuous data
Proportions will be calculated for categorical data.
Missing data will not be imputed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
298
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25231 0
Ashford Community Hospital - Ashford
Recruitment hospital [2] 25232 0
North Eastern Community Hospital Inc - Campbelltown
Recruitment postcode(s) [1] 40903 0
5035 - Ashford
Recruitment postcode(s) [2] 40904 0
5074 - Campbelltown

Funding & Sponsors
Funding source category [1] 314338 0
Commercial sector/Industry
Name [1] 314338 0
Smartfem Medical Technology Pty Ltd
Country [1] 314338 0
Australia
Funding source category [2] 314340 0
Commercial sector/Industry
Name [2] 314340 0
FBW Gynaecology Plus
Country [2] 314340 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
FBW Gynaecology Plus
Address
46 Marleston Ave, Ashford, SA, 5035
Country
Australia
Secondary sponsor category [1] 316286 0
Commercial sector/Industry
Name [1] 316286 0
Smartfem Medical Technology Pty Ltd
Address [1] 316286 0
46 Marleston Ave, Ashford, SA, 5035
Country [1] 316286 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313438 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313438 0
123 Glen Osmond Road Eastwood AdelaideSouth Australia 5063
Ethics committee country [1] 313438 0
Australia
Date submitted for ethics approval [1] 313438 0
12/11/2022
Approval date [1] 313438 0
19/09/2023
Ethics approval number [1] 313438 0
2022-11-1211

Summary
Brief summary
Pelvic organ prolapse (POP) is a common gynaecological condition with an incidence of 40-60%, and 12-19% of women undergo surgical correction. Standard technique of native tissue repair (NTR) relying on damaged tissue is associated with variable success and recurrence rate up to 30-50% initiating the exploration of innovative surgical techniques and grafts to improve long-term outcomes. Surgery is preferential for younger women with more severe symptoms related to quality of life, if also affecting bladder, bowel, and sexual function. Use of transvaginal polypropylene mesh is no longer accepted in most of the global market due to unfavourable complications of increased reoperation rates, mesh erosion, dyspareunia, and chronic pelvic pain. Surgical techniques using biological grafts or absorbable mesh to augment POP have been trialled, with systematic reviews based on low quality evidence demonstrating minimal advantage compared with NTR regarding rates of awareness of prolapse or reoperation. Low to moderate quality evidence suggests higher recurrence rates for anterior prolapse after NTR than with biological grafts.

This is a randomised controlled trial comparing two surgical approaches for pelvic organ prolapse treatment: Intervention Group with autologous graft augmentation and Control Group with conventional prolapse repair surgery. In Group 1, patients undergo native tissue repair surgery for vaginal prolapse, with an autologous graft prepared from 40mls of the patient's own blood during surgery. The graft is then sutured or glued to the underlying connective tissue. In Group 2, patients undergo the same surgery as Group 1 but without the creation of a graft.

Postoperative care is identical for both groups, including routine instructions on physical activity, bowel habits, and abstinence from intercourse for six weeks. Patients are followed up teleconsult at one week and face-to-face at 6 weeks, 6 months, and 12 months.

Participants are invited to the study after being diagnosed with pelvic organ prolapse that requires pelvic floor repair surgery, having tried medications and non-surgical alternatives with persistent symptoms. The study includes an initial assessment consultation, surgery, and three follow-up assessments at 6 weeks, 6 months, and 12 months after the treatment.

No medical expenses are incurred during these consultations or treatments, and both specialists involved in patient care will be responsible for administering the study treatment and performing the assessments. The assessment consultations involve evaluating the pelvic organ prolapse, bowel, bladder, and sexual function to determine the treatment's effectiveness.

This study aims to provide valuable insights into the efficacy of autologous graft augmentation compared to conventional prolapse repair surgery, contributing to improved treatment options for patients suffering from pelvic organ prolapse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128162 0
Dr Tran Nguyen
Address 128162 0
FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035
Country 128162 0
Australia
Phone 128162 0
+61 8 8297 2822
Fax 128162 0
Email 128162 0
tran.nguyen2@sa.gov.au
Contact person for public queries
Name 128163 0
Dr Tran Nguyen
Address 128163 0
FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035
Country 128163 0
Australia
Phone 128163 0
+61 8 8297 2822
Fax 128163 0
Email 128163 0
tran.nguyen2@sa.gov.au
Contact person for scientific queries
Name 128164 0
Dr Tran Nguyen
Address 128164 0
FBW Gynaecology Plus 46 Marleston Avenue Ashford SA 5035
Country 128164 0
Australia
Phone 128164 0
+61 8 8297 2822
Fax 128164 0
Email 128164 0
tran.nguyen2@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19776Informed consent form    386276-(Uploaded-21-07-2023-15-07-16)-Study-related document.pdf
19777Study protocol    386276-(Uploaded-25-09-2023-19-14-52)-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.