跳至主要内容
临床试验/NCT07146659
NCT07146659招募中不适用

Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure.

研究概览

简要总结

This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.

详细描述

Operative hysteroscopy is a key technique for the treatment of intrauterine pathologies such as endometrial polyps, submucosal fibroids, retained products of conception. Traditionally, operative hysteroscopies are performed in the operating room under general or regional anesthesia, requiring either ambulatory or inpatient hospitalization.

In recent years, advances in hysteroscopic instrumentation and procedural techniques have made it possible to perform selected operative hysteroscopies in outpatient settings (consultation office) without general or regional anesthesia. Several studies have demonstrated the feasibility, safety, and effectiveness of outpatient operative hysteroscopy, with similar success rates and complication profiles compared to procedures performed in the operating room, although some studies reported higher levels of pain during outpatient procedures (1-3) . Furthermore, cost-effectiveness studies support outpatient procedures by highlighting reduced hospital resource utilization and shorter recovery times for patients (4-6).

The HOPE study aims to evaluate this practice locally at the Centre Hospitalier Intercommunal de Créteil. This prospective monocentric observational study will include approximately 400 patients over a two-year period (July 2025 - May 2027). The primary objective is to compare the success rates of operative hysteroscopies performed in the operating room versus those performed in an outpatient setting. Secondary objectives include assessment of perioperative and postoperative pain, patient satisfaction, complication rates, and the time to return to work.

Data will be collected from medical records and patient-reported outcomes using a satisfaction questionnaire. Inclusion of patients will follow the usual care pathway, without additional interventions or follow-up beyond standard clinical practice.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged ≥ 18 years
  • ⁃ Undergoing operative hysteroscopy for intrauterine pathology
  • Able to provid e informed non-opposition
  • French-speaking

排除标准

  • Patients with contraindications to hysteroscopy
  • Pregnancy
  • Inability to complete follow-up

结局指标

主要结局

This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure.

时间窗: The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)

次要结局

  • Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)(During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline))
  • Patient satisfaction Assessed using a locally developed patient satisfaction questionnaire(At hospital discharge.(assessed up to 5 days))
  • Complications including uterine perforation, hemorrhage, and postoperative infection(Recorded during the procedure and immediately afterward (documented in the operative report and medical records), and up to 8 weeks postoperatively during the follow-up consultation if necessary.)
  • 4. Time to return to work Measured as the number of days of sick leave prescribed and actually taken.(Up to 8 weeks postoperatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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