Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
NCT ID: NCT01526668
Last Updated: 2022-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
525 participants
INTERVENTIONAL
2011-10-11
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
NCT01442961
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain
NCT01537731
Hysterectomy - A Regional Intervention Study
NCT05255120
Clinical Analysis of Pain After Hysterectomy
NCT01706549
Clinical Follow up After Subtotal and Total Hysterectomy
NCT02166749
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No contact after discharge
Single telephone contact
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.
Follow-up strategy
Comparison of different follow-up strategies
Telephone contacts regularly
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.
Follow-up strategy
Comparison of different follow-up strategies
Telephone contact using CBT-inspired 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.
Follow-up strategy
Comparison of different follow-up strategies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Follow-up strategy
Comparison of different follow-up strategies
No contact after discharge
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Linkoeping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Preben Kjolhede, MD, professor
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Preben Kjolhede, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, Sweden
Ninnie Borendal Wodlin, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
Lena Nilsson, MD, PhD
Role: STUDY_CHAIR
Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden
Gunilla Sydsjo, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
Gulnara Kassymova, MD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
Peter Lukas, MD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
Björn Gerdle, MD, PhD
Role: STUDY_CHAIR
Pain and Rehabilitation Center, University Hospital, 581 85 Linkoping, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynecology, Höglandshospital
Eksjö, Jonkopings Län, Sweden
Department of Obstetrics and Gynecology, Ryhov Central Hospital
Jönköping, Jonkopings Län, Sweden
Department of Obstetrics and Gynecology
Värnamo, Jonkopings Län, Sweden
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, Sweden
Department of Obstetrics and Gynecology, Vrinnevi Hospital
Norrköping, Östergötland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
POSTHYSTREC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.