Hysterectomy - A Regional Intervention Study

Postoperative Recovery Clinical Trial

— HYSTERI  

Official title:

The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255120
• Other study ID #: HYSTERI
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Linkoeping
• Contact: Preben Kjölhede, MD PhD
• Phone: +46101030000
• Email: preben.kjolhede[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Hysterectomy
• Postoperative Recovery

Intervention

Other:
• Intiensified structured perioperative information
The doctor takes a medical history and examines the patient according to regular routines, but uses the algorithm as support in deciding on the surgical method. After the doctor's visit, the patient must see a research nurse to receive the intensified preoperative information about hysterectomy. This information is designed according to a checklist. The patient can also download a mobile application. The study-specific mobile application (app) contains information about hysterectomy. The information is structured in three parts - Before the Operation, At the Hospital and After the Operation. A timeline describes the activities and events that occur before, around and after the operation. Within each section there are several information links, with eg checklists.

Locations

Country	Name	City	State
Sweden	University Hospital	Linköping
Sweden	Vrinnevisjukhuset	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unexpected postoperative symtoms	Proportion of patients with unexpected symptoms.	Up to one year postoperatively
Primary	Proportion minimally invasive hysterectomy	Proportion of women undergoing hysterectomy as a minimally invasive procedure	Retrospecive data 5 years before study start until completion of prospective study
Secondary	Complication	Numbers of and types of patient reported complications	Up to one year postoperatively
Secondary	Lenght of stay	Hospital length of stay in connection with surgery	Day of surgery until discharge from hospital pre- and during the intervention
Secondary	Sick leave	return to work measured as actual sick leave length	Day of discharge from hospital after surgery until return to normal work, maximal one year
Secondary	Recovery	time to normal daily activity (ADL)	Day of surgery until normal ADL, maximal one year
Secondary	Health related quality of life	Measured with EuroQol EQ-5D-3L health index comprising of two parts. Part A Scale -0.5941 to 1. A higher number indicates better quality of life. Part B. EuroQol visual analoque scale EQ-VAS. Scale 0-100. A higher number indicates better quality of life	Preoperatively up to one year postoperatively