A study comparing pelvic organ prolapse surgery in women with or without graft made from blood

Phase 2

• Conditions: Pelvic organ prolapse; Renal and Urogenital - Other renal and urogenital disorders; Surgery - Other surgery

• Registration Number: ACTRN12623001192673
• Lead Sponsor: FBW Gynaecology Plus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-17
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 298

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.

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

• Study Type: Interventional
• Study Design: Not specified