None listed
Conditions
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.
Interventions
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, an
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.
Sponsors
FBW Gynaecology Plus
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed