Study of Outpatient Management for Promontofixation by Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
研究概览
简要总结
Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection.
The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life.
The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis.
To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with promontofixation indication by laparoscopy for prolapse cure
- •Patient's desire for outpatient management
- •Age ≥18 years and <70 years
- •Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome)
- •Subject affiliated to a social security scheme
- •Subject having signed an informed consent
- •Availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home
- •Geographical distance less than one hour from a suitable care facility
- •Access to a telephone or a means of transport if necessary
- •Patient compliance
- •Oral and written comprehension of pre- and post-operative instructions
- •Correct housing condition
- •Subject having been informed of the results of the prior medical examination
排除标准
- •Laparoscopic contraindication
- •Comorbidity needs of medical supervision most of 24h
- •TVT-O procedure during the same surgery
- •Mental handicap affecting autonomy
- •Comprehension difficulties to understand the protocol
- •No social protection
- •Subject with curatorship or guardianship
- •Morbid obesity
- •Alcohol or drugs addiction
- •Excessive anxiety
- •Impossibility to give the subject enlightened information (subject in emergency situation...)
- •Pregnant woman (positive urinary pregnancy test for women of childbearing age)
结局指标
主要结局
Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
时间窗: 35 to 70 Days after the intervention
Rate of rehospitalizations occurring between outpatient discharge and postoperative
次要结局
- Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.(Day 0, 1, 2, 3, 7 and 30 after the intervention)
- Rates of postoperative complications(35 to 70 Days after the intervention)
- Number of emergency consultations before scheduled postoperative follow-up consultation(35 to 70 Days after the intervention)
- Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire(Day 30 after the intervention)
- Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.(8 hours after surgery (Day 0)/ At 8 a.m. and 6 p.m. (Day 1, 2 and 3)/ At 8 a.m. (Day 4, 5, 6, 7 and 30))
- Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.(Hour 8 after the intervention)
- Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)(Day 0, 3, 7 and 30 after the intervention)
- Difference in actual costs and cost-effectiveness between conventional and outpatient care(35 to 70 Days after the intervention)