The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- Proportion minimally invasive hysterectomy
研究概览
简要总结
Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences in preoperative information, planning of surgery and surgical technique. A structured approach including the use of mobile phone technology can possibly improve patient information and patient involvement. Our purpose is to to evaluate whether systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication.
详细描述
Background Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences between clinics in Sweden in the proportion of hysterectomies conducted using minimally invasive surgery. There is no uniformity in the planning of surgery. Patient-reported outcome measures, such as satisfaction and postoperatively unexpected symptoms, are important in assessing the outcome of surgery. Patient-reported measurements are, besides other factors, dependent on preoperative information. Mobile phone technology can possibly improve patient information and patient involvement.
Purpose
To evaluate whether a systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication. The work consists of three parts with the following purposes:
Sub-study 1: To evaluate the effect of a preoperative algorithm for determining the most appropriate method of hysterectomy on the proportion undergoing surgery as a minimally invasive procedure and on the frequency of complications.
Sub-study 2: To compare patient-reported outcome measures, including unexpected symptoms, recovery, and satisfaction, in women who receive systematic preoperative information from specially trained staff and a mobile application with targeted education on the procedure, with women who receive information according to normal routines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 - 55 years old.
- •Women undergoing hysterectomy for benign indication.
- •Women with ASA 1 -
- •Women who understand and can express themselves in Swedish.
- •Women who, by signing "Informed Consent", agree to participate in the study after written and oral information.
- •Women who participate and respond to the surveys in the GynOp register.
- •Women who have access to an I-phone, smartphone, computer or tablet and who can use the study-specific mobile application. (Does not apply to sub-study 1).
排除标准
- •Women where both ovaries are removed during the operation.
- •Women undergoing hysterectomy for prolapse indication.
- •Women undergoing hysterectomy for cancer prophylactic indication.
- •Women undergoing hysterectomy for gender reassignment purposes.
- •Women with intellectual disabilities to such an extent that they can not fill in the relevant questionnaires etc. or if they do not understand the meaning of participating in the study or where there may be ethical doubts about the patient's participation in the study.
- •Women who have a mental illness of such severity that the doctor in charge considers it inappropriate for the patient to be included in the study.
结局指标
主要结局
Proportion minimally invasive hysterectomy
时间窗: Retrospecive data 5 years before study start until completion of prospective study
Proportion of women undergoing hysterectomy as a minimally invasive procedure
Unexpected postoperative symtoms
时间窗: Up to one year postoperatively
Proportion of patients with unexpected symptoms.
次要结局
- Complication(Up to one year postoperatively)
- Recovery(Day of surgery until normal ADL, maximal one year)
- Lenght of stay(Day of surgery until discharge from hospital pre- and during the intervention)
- Health related quality of life(Preoperatively up to one year postoperatively)
- Sick leave(Day of discharge from hospital after surgery until return to normal work, maximal one year)
研究者
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping