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临床试验/NCT04378400
NCT04378400Enrolling By Invitation不适用

An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
250
试验地点
1
主要终点
Subjective Success Rate

研究概览

简要总结

An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.

详细描述

The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.

Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.

The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.

High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.

Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • To be eligible, female subjects must meet the following inclusion criteria:
  • Having undergone laparoscopic sacrocolpoexy at our unit.
  • Agreeing to participate in the study, including completion of study-related procedures, evaluations and questionnaires, and giving informed consent.
  • Follow up period of at least 6 months since the operation.

排除标准

  • None apart from not meeting the above criteria

结局指标

主要结局

Subjective Success Rate

时间窗: Up to 10 years postoperative

Subjective Success assessed by the Patient Global Impression of Change (PGI-C) tool, which is a 5-point Likert scale, where the patients are asked the following question at the follow up visit: "Compared with how you were doing before your recent pelvic floor operation, would you say that now you are: "much better", "a little better", "about the same", "a little worse" or "much worse".

次要结局

  • Prolapse Quality of Life (P-QoL)(Up to 10 years postoperative)
  • Postoperative complications(Up to 10 years postoperative)
  • Objective success(Up to 10 years postoperative)
  • Reintervention rate(Up to 10 years postoperative)
  • Postoperative graft related complications (GRC)(Up to 10 years postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Jan Deprest

MD, PhD

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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