Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-30 @ 3:47 PM
Study NCT ID:
NCT01526668
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life as measured by the EQ-5D health index', 'timeFrame': 'Six weeks', 'description': '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.'}, {'measure': 'Quality of life as measured by the SF-36 sub scale scores', 'timeFrame': 'Six weeks', 'description': 'The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks'}], 'secondaryOutcomes': [{'measure': 'Postoperative symptoms', 'timeFrame': 'Six weeks', 'description': 'Selfreported symptoms in the Swedish Postoperative Symptom Questionnaire. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.'}, {'measure': 'Consumption of analgesic', 'timeFrame': 'Six weeks', 'description': 'Total amount of opioids and non-opioids from surgery to six weeks postoperatively'}, {'measure': 'Complications related to operation', 'timeFrame': 'Six weeks', 'description': 'From surgery to six weeks postoperatively'}, {'measure': 'Health economy', 'timeFrame': 'Up to 1 years', 'description': 'Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work'}, {'measure': 'Development of chronic pelvic pain', 'timeFrame': 'One year', 'description': 'Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively'}, {'measure': 'Duration of sick-leave', 'timeFrame': 'Up to one year', 'description': 'Time from day of surgery to return to work at same level as preoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Hysterectomy', 'Genital Diseases, Female', 'Pain']}, 'referencesModule': {'references': [{'pmid': '40314809', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39707275', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38558946', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36050542', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33232628', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Contact sponsor if detailed information is requested.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between 18 and 60 years of age.\n* Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia).\n* Women who understand and speak Swedish fluently.\n* Women who gives signed informed consent to participate in the study.\n* Women who have access to a telephone and/or internet.\n\nExclusion Criteria:\n\n* Women where the hysterectomy is carried out in association with surgery for genital prolapse\n* Women with genital malignancies (does not include cervical dysplasia).\n* Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant.\n* Women with previous bilateral salpingooophorectomy.\n* Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual.\n* 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.\n* Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable.\n* Women with current drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT01526668', 'acronym': 'POSTHYSTREC', 'briefTitle': 'Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy', 'orgStudyIdInfo': {'id': 'POSTHYSTREC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No contact after discharge', 'description': '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.', 'interventionNames': ['Behavioral: No contact after discharge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single telephone contact', 'description': '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.', 'interventionNames': ['Behavioral: Follow-up strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone contacts regularly', 'description': '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.', 'interventionNames': ['Behavioral: Follow-up strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone contact using CBT-inspired strategy', 'description': '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.', 'interventionNames': ['Behavioral: Follow-up strategy']}], 'interventions': [{'name': 'Follow-up strategy', 'type': 'BEHAVIORAL', 'description': 'Comparison of different follow-up strategies', 'armGroupLabels': ['Single telephone contact', 'Telephone contact using CBT-inspired strategy', 'Telephone contacts regularly']}, {'name': 'No contact after discharge', 'type': 'BEHAVIORAL', 'armGroupLabels': ['No contact after discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57533', 'city': 'Eksjö', 'state': 'Jonkopings Län', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology, Höglandshospital', 'geoPoint': {'lat': 57.66643, 'lon': 14.97205}}, {'zip': '551 85', 'city': 'Jönköping', 'state': 'Jonkopings Län', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology, Ryhov Central Hospital', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'zip': '331 85', 'city': 'Värnamo', 'state': 'Jonkopings Län', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 57.18604, 'lon': 14.04001}}, {'zip': '58185', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology, University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '60779', 'city': 'Norrköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology, Vrinnevi Hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}], 'overallOfficials': [{'name': 'Preben Kjolhede, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, Sweden'}, {'name': 'Ninnie Borendal Wodlin, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden'}, {'name': 'Lena Nilsson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden'}, {'name': 'Gunilla Sydsjo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden'}, {'name': 'Gulnara Kassymova, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden'}, {'name': 'Peter Lukas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden'}, {'name': 'Björn Gerdle, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pain and Rehabilitation Center, University Hospital, 581 85 Linkoping, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Preben Kjolhede, MD, professor', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}