The WISH Trial (Web-based Versus Standard Information for Same Day Hysterectomy)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Same Day Discharge following laparoscopic hysterectomy (0-23hours)
研究概览
简要总结
Objectives: To evaluate the potential utility and efficacy of additional on-line, patient education resource for same day discharge following laparoscopic hysterectomy (SDD LH) compared to standard information resources alone
Trial Design: A pilot, parallel, open, single centre, randomised controlled trial
Participant Population and Sample Size: 40 women undergoing SDD LH for a benign reason
Eligibility Criteria: Women with gynaecological conditions requiring a laparoscopic hysterectomy (LH) and who are suitable for same day discharge (SDD).
Interventions: An online patient education website resource and the comparator is standard practice for provision of patient information (written and verbal).
Outcome Measures:
Primary
- Compliance with SDD Secondary
- In Hospital:
o Surgical details / complexity / intraoperative and post-operative serious adverse events (SAEs) according to the Clavien-Dindo system grade II-IV which is a widely used index for the classification of surgical complications [case notes and electronic patient record], and time to discharge
-
6 weeks:
-
Satisfaction, acceptability and utility of patient education / information provided (bespoke patient questionnaire; Likert scales)
-
Satisfaction with care after LH (6-point Likert)
-
Generic quality of life at 6 weeks post-surgery (EuroQol-5D-5L and VAS);
-
Contact with Community & Clinical Care Services i.e. outpatients or emergency visits, re-presentations / re-admissions to hospital (Case report form [CRF], case notes, electronic patient record)
-
Serious Adverse Events (CRF, case notes, electronic patient record)
-
Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (Modified items / response categories)
-
12 weeks:
-
Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (Modified items / response categories) Time to return to work (if working)
详细描述
Aim:
To evaluate the potential efficacy of additional on-line, patient education for SDD LH in achieving SDD compared to standard information giving. In addition, the utility and acceptability of patient information will be assessed as well as the impact on patient satisfaction and recovery.
Objectives:
The investigators aim to assess various aspects of trial management and design. In order to achieve this, the objectives of the pilot randomised controlled trial (RCT) will be split into:
- Process Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent to participate
- •Have a benign gynaecological condition that is being treated with a LH
- •Eligible to be on same day discharge pathway Patient factors
- •ASA I/II with no sleep apnoea. ASA III may be suitable if comorbidities are stable and optimised.
- •No known cardio-pulmonary compromise
- •No known renal disease
- •Age </= 60 years
- •Not indication for admission to Gynaecological Extended Recovery Area (GERU)
- •Surgical factors
- •Presumed benign disease
- •No anticipated surgical complications
- •Concomitant procedures acceptable but surgeon to decide on a case by case basis Discharge factors
- •Residence < 1 hour from BWCH
- •Access to transport from hospital to home
排除标准
- •Patient above the age of 60
- •Unwillingness or inability to comply with protocol procedures
- •Women who require concomitant gynaecological surgery for bladder or other pelvic support
- •Women who require concomitant gynaecological surgery for excision of deep endometriosis that requires dissection of the pararectal space above the age of 60
- •Unwillingness or inability to comply with protocol procedures
- •Women who require concomitant gynaecological surgery for bladder or other pelvic support
- •Women who require concomitant gynaecological surgery for excision of deep endometriosis that requires dissection of the pararectal space
结局指标
主要结局
Same Day Discharge following laparoscopic hysterectomy (0-23hours)
时间窗: 0-24hours following surgery
This means that the patient is discharged (leaves the hospital) before midnight on the day of surgery (case notes / electronic patient record).
次要结局
- Time from surgery to resumption of usual activities in days(6-12 weeks)
- Satisfaction with care on discharge (bespoke patient questionnaire score)(0-24hours following surgery)
- Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score)(6 weeks)
- Time to return to work (if working) in days(6-12 weeks)
- Acceptability and utility of patient education / information provided (score)(6 weeks)
- Satisfaction with care on discharge (score)(6 weeks)
- Contact with Community & Clinical Care Services(6 weeks)
- Generic quality of life post-surgery (score)(6 weeks)