Clinical trial NCT05255120: Hysterectomy - A Regional Intervention Study
Official title: The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Hysterectomy
Postoperative Recovery
Preoperative Planning
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Women 18 - 55 years old.
* Women undergoing hysterectomy for benign indication.
* Women with ASA 1 - 3.
* 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.
* 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.

Primary outcomes:
measure: Unexpected postoperative symtoms
timeFrame: Up to one year postoperatively
measure: Proportion minimally invasive hysterectomy
timeFrame: Retrospecive data 5 years before study start until completion of prospective study
Secondary outcomes:
measure: Complication
timeFrame: Up to one year postoperatively
measure: Lenght of stay
timeFrame: Day of surgery until discharge from hospital pre- and during the intervention
measure: Sick leave
timeFrame: Day of discharge from hospital after surgery until return to normal work, maximal one year
measure: Recovery
timeFrame: Day of surgery until normal ADL, maximal one year
measure: Health related quality of life
timeFrame: Preoperatively up to one year postoperatively
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
Study officials:
affiliation: University Hospital, Linköing
name: Preben Kjölhede, MD PhD
role: STUDY_CHAIR
affiliation: Vrinnevi Hospital, Norrköping
name: Lollo Makdessi, MD
role: STUDY_CHAIR
References:
citation: Bjorkstrom LM, Wodlin NB, Nilsson L, Kjolhede P. The Impact of Preoperative Assessment and Planning on the Outcome of Benign Hysterectomy - a Systematic Review. Geburtshilfe Frauenheilkd. 2021 Feb;81(2):200-213. doi: 10.1055/a-1263-0811. Epub 2021 Feb 8.