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

INTERVENTION: 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 si Xweeks, si Xmonths, and 12 months. CONDITION: Pelvic organ prolapse; ; Pelvic organ prolapse Renal and Urogenital ‐ Other renal and urogenital disorders Surgery ‐ Other surgery PRIMARY OUTCOME: 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. [ 12‐month post‐op follow‐up visit] SECONDARY OUTCOME: 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[ Post‐op, 6 weeks, 6 months, and 12 months postop] need for analgesia by review of medical records[ at baseline, 6 weeks, 6 months, 12 months postop] pain score by visual analogue scale by review of medical records[ at baseline, 6 weeks, 6 months, 12 months post‐op] Pain score postop by pain visual analogue scale and need for analgesia will be compared in both groups.[ Post‐op (within 24 hours post‐surgery)] 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. [ at 6 weeks, 6 months, and 12 months post‐op.] 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 (cervi Xor 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.