Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

Study Overview
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Brief Summary
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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
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Contact sponsor if detailed information is requested.

Official Title
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A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

Conditions
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Hysterectomy, Genital Diseases, Female, Pain

Intervention / Treatment
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* Behavioral: Follow-up strategy
* Behavioral: No contact after discharge


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No contact after discharge<br>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. | Behavioral: No contact after discharge<br> <br> |
| Active Comparator: Single telephone contact<br>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. | Behavioral: Follow-up strategy<br>* Comparison of different follow-up strategies<br>|
| Active Comparator: Telephone contacts regularly<br>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. | Behavioral: Follow-up strategy<br>* Comparison of different follow-up strategies<br>|
| Active Comparator: Telephone contact using CBT-inspired strategy<br>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. | Behavioral: Follow-up strategy<br>* Comparison of different follow-up strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by the EQ-5D health index | 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. | Six weeks | 
| Quality of life as measured by the SF-36 sub scale scores | The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks | Six weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign gynecological disease, Surgery, Postoperative follow-up strategy, Pain threshold, Chronic pelvic pain, [E04.950.300.399], [C13.351.500], [F02.463.593.710.560], [N02.421.585.722.700], Postoperative Care