The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Linkoeping
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Proportion minimally invasive hysterectomy
Overview
Brief Summary
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.
Detailed Description
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.
Sub-study 3: To investigate how women experience digitized information via a mobile application in connection with surgery.
Participating centers Departments of obstetrics and gynecology at the hospitals in Norrköping, Jönköping, Eksjö, Värnamo, Västervik, Kalmar and Växjö.
Schedule The study starts in September 2020. Recruitment of patients is planned to take two years.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •Exclusion criteria
- •Women where both ovaries are removed during the operation.
- •Women undergoing hysterectomy for prolapse indication.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion minimally invasive hysterectomy
Time Frame: 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
Time Frame: Up to one year postoperatively
Proportion of patients with unexpected symptoms.
Secondary Outcomes
- 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)
Investigators
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping