Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

Not Applicable

Completed

• Conditions: Hysterectomy; Genital Diseases, Female; Pain
• Interventions: Behavioral: No contact after discharge; Behavioral: Follow-up strategy

• Registration Number: NCT01526668
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

The purpose of the study is to investigate the effect of four different follow-up strategies on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions. Furthermore the investigators aim to examine associations between preoperative thresholds for pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain after benign hysterectomy.

Detailed Description

Contact sponsor if detailed information is requested.

Study Timeline

• Study Start: 2011-10-11
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 525

Inclusion Criteria

• Women between 18 and 60 years of age.
• Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia).
• Women who understand and speak Swedish fluently.
• Women who gives signed informed consent to participate in the study.
• Women who have access to a telephone and/or internet.

Exclusion Criteria

• Women where the hysterectomy is carried out in association with surgery for genital prolapse
• Women with genital malignancies (does not include cervical dysplasia).
• Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant.
• Women with previous bilateral salpingooophorectomy.
• Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual.
• Women who are mentally disabled to a degree so she cannot complete the forms in the study or understand the tenor of the participation or it is considered doubtful from an ethical point of view to participate.
• Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable.
• Women with current drug or alcohol abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No contact after discharge	No contact after discharge	In Arm A: The patient do not have planned contacts with the study nurse or doctor after discharge. All patients are seen by the study nurse six weeks postoperatively.
Telephone contact using CBT-inspired strategy	Follow-up strategy	In Arm C: The patient has planned telephone contacts with the study nurse the day after discharge and then once weekly until the six weeks follow-up visit postoperatively. At these telephone contacts the study nurse uses a cognitive behavior therapy (CBT)-inspired strategy in counselling and support.
Telephone contacts regularly	Follow-up strategy	In Arm C: The patient has planned telephone contacts with the study nurse the day after discharge and then once weekly until the six weeks follow-up visit postoperatively.
Single telephone contact	Follow-up strategy	In Arm B: The patient has one planned telephone contact with the study nurse the day after discharge. All patients are seen by the study nurse six weeks postoperatively.

Primary Outcome Measures

Name	Time	Method
Quality of life as measured by the EQ-5D health index	Six weeks	The Euroqol questionnaire form (EQ-5D) are used for assessing the quality of life. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.
Quality of life as measured by the SF-36 sub scale scores	Six weeks	The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks

Secondary Outcome Measures

Name	Time	Method
Complications related to operation	Six weeks	From surgery to six weeks postoperatively
Health economy	Up to 1 years	Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work
Consumption of analgesic	Six weeks	Total amount of opioids and non-opioids from surgery to six weeks postoperatively
Duration of sick-leave	Up to one year	Time from day of surgery to return to work at same level as preoperatively
Postoperative symptoms	Six weeks	Selfreported symptoms in the Swedish Postoperative Symptom Questionnaire. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.
Development of chronic pelvic pain	One year	Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively

Trial Locations

Locations (5)

Department of Obstetrics and Gynecology, Höglandshospital; 🇸🇪 Eksjo, Jonkopings Län, Sweden

Department of Obstetrics and Gynecology, Ryhov Central Hospital; 🇸🇪 Jonkoping, Jonkopings Län, Sweden

Department of Obstetrics and Gynecology; 🇸🇪 Varnamo, Jonkopings Län, Sweden

Department of Obstetrics and Gynecology, University Hospital; 🇸🇪 Linkoping, Ostergotland, Sweden

Department of Obstetrics and Gynecology, Vrinnevi Hospital; 🇸🇪 Norrkoping, Ostergotland, Sweden