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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.
Contact sponsor if detailed information is requested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No contact after discharge | Active Comparator | 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. |
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| Single telephone contact | Active Comparator | 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. |
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| Telephone contacts regularly | Active Comparator | 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. |
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| Telephone contact using CBT-inspired strategy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up strategy | Behavioral | Comparison of different follow-up strategies |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preben Kjolhede, MD, PhD | Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, Sweden | Study Chair |
| Ninnie Borendal Wodlin, MD, PhD | Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden | Study Chair |
| Lena Nilsson, MD, PhD | Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden | Study Chair |
| Gunilla Sydsjo, PhD | Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden | Study Chair |
| Gulnara Kassymova, MD | Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden | Study Chair |
| Peter Lukas, MD | Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden | Study Chair |
| Björn Gerdle, MD, PhD | Pain and Rehabilitation Center, University Hospital, 581 85 Linkoping, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Höglandshospital | Eksjö | Jonkopings Län | 57533 | Sweden | ||
| Department of Obstetrics and Gynecology, Ryhov Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40314809 | Derived | Kassymova G, Davidson T, Sydsjo G, Wodlin NB, Nilsson L, Kjolhede P. Cost analysis of nurse-lead telephone follow-ups after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial. Arch Gynecol Obstet. 2025 Aug;312(2):515-523. doi: 10.1007/s00404-025-08035-1. Epub 2025 May 2. | |
| 39707275 | Derived |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D010146 | Pain |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| No contact after discharge | Behavioral |
|
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 |
| Jönköping |
| Jonkopings Län |
| 551 85 |
| Sweden |
| Department of Obstetrics and Gynecology | Värnamo | Jonkopings Län | 331 85 | Sweden |
| Department of Obstetrics and Gynecology, University Hospital | Linköping | Östergötland County | 58185 | Sweden |
| Department of Obstetrics and Gynecology, Vrinnevi Hospital | Norrköping | Östergötland County | 60779 | Sweden |
| Lukas P, Nilsson L, Wodlin NB, Arendt-Nielsen L, Kjolhede P. Changes in spatial bodily pain distribution one year after benign hysterectomy with emphasis on prevalence and risk factors for de novo and persistent pelvic pain- a prospective longitudinal multicenter study. BMC Womens Health. 2024 Dec 20;24(1):644. doi: 10.1186/s12905-024-03474-5. |
| 38558946 | Derived | Kassymova G, Sydsjo G, Borendal Wodlin N, Nilsson L, Kjolhede P. The Impact of Symptoms of Depression, Anxiety, and Low Stress-Coping Capacity on the Effects of Telephone Follow-Up on Recovery Measures After Hysterectomy. Womens Health Rep (New Rochelle). 2024 Mar 27;5(1):304-318. doi: 10.1089/whr.2023.0045. eCollection 2024. |
| 36050542 | Derived | Kassymova G, Sydsjo G, Wodlin NB, Nilsson L, Kjolhede P. Effect of nurse-led telephone follow-up on postoperative symptoms and analgesics consumption after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial. Arch Gynecol Obstet. 2023 Feb;307(2):459-471. doi: 10.1007/s00404-022-06722-x. Epub 2022 Sep 2. |
| 33232628 | Derived | Kassymova G, Sydsjo G, Borendal Wodlin N, Nilsson L, Kjolhede P. The Effect of Follow-Up Contact on Recovery After Benign Hysterectomy: A Randomized, Single-Blinded, Four-Arm, Controlled Multicenter Trial. J Womens Health (Larchmt). 2021 Jun;30(6):872-881. doi: 10.1089/jwh.2020.8752. Epub 2020 Nov 24. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |