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临床试验/ACTRN12623001192673
ACTRN12623001192673尚未招募2 期

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

FBW Gynaecology Plus0 个研究点目标入组 298 人开始时间: 2023年11月17日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
298

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
19 Years 至 o limit(—)
性别
Female

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
FBW Gynaecology Plus

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