Hysterectomy - A Regional Intervention Study

NCT05255120 | Completed

• 1 other identifier: HYSTERI
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Hysterectomy; Postoperative Recovery; Preoperative Planning

Outcome Measures

Primary Outcomes (2)

• Unexpected postoperative symtoms

  Proportion of patients with unexpected symptoms.

  Up to one year postoperatively

• 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 Outcomes (5)

• Complication

  Up to one year postoperatively

• Lenght of stay

  Day of surgery until discharge from hospital pre- and during the intervention

• Sick leave

  Day of discharge from hospital after surgery until return to normal work, maximal one year

• Recovery

  Day of surgery until normal ADL, maximal one year

• Health related quality of life

  Preoperatively up to one year postoperatively

Study Arms (2)

Intensified preoperative information

EXPERIMENTAL

The patient participating in the intervention group is evaluated preoperatively based on an algorithm. This information is designed according to a checklist which includes how the procedure is performed, rules of conduct in connection with and after the procedure and what the patient can expect after surgery.

Other: Intiensified structured perioperative information

Control group

NO INTERVENTION

The patient who participates in the control group receives information about participation in the study as a control, ie without information about the intervention. The patient will then be planned for the procedure according to current, local routines.

Interventions

Intiensified structured perioperative information OTHER

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.

Intensified preoperative information

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Patients undergoing hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (2)

University Hospital

Linköping, 58185, Sweden

Location

Vrinnevisjukhuset

Norrköping, 58185, Sweden

Location

Related 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.

  PMID: 33574624 BACKGROUND

Study Officials

• Preben Kjölhede, MD PhD

  University Hospital, Linköing

  STUDY CHAIR

• Lollo Makdessi, MD

  Vrinnevi Hospital, Norrköping

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 24, 2022
• Study Start: September 4, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)