Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT02291406
Status:
UNKNOWN
Last Update Posted:
2014-11-14
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '3 weeks', 'description': 'Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp, a method that now is the golden standard for determining insulin sensitivity. The clamp is measured 1-2 weeks before surgery and on the morning after surgery.'}], 'secondaryOutcomes': [{'measure': 'Changes in biomarkers of inflammation and the immune system.', 'timeFrame': '3 weeks', 'description': 'Biomarkers for example IL6 and CRP are measured. Biomarkers are measured two times during the hyperinsulinemic normoglycemic clamp before surgery, 3 hours after surgery and two times during the clamp after surgery.'}, {'measure': '6 minutes walk test', 'timeFrame': '3 weeks', 'description': 'Measured before surgery and on the day after surgery 25-26 hours after surgery.'}, {'measure': 'postoperative outcomes', 'timeFrame': '4 weeks', 'description': 'Postoperative outcome is registered systematically according to the ERAS Society register.'}, {'measure': 'complications', 'timeFrame': '4 weeks', 'description': 'Adverse events are registered systematically from start of anesthesia to 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hysterectomy', 'Insulin resistance', 'Metabolism'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '28043722', 'type': 'DERIVED', 'citation': 'Wijk L, Nilsson K, Ljungqvist O. Metabolic and inflammatory responses and subsequent recovery in robotic versus abdominal hysterectomy: A randomised controlled study. Clin Nutr. 2018 Feb;37(1):99-106. doi: 10.1016/j.clnu.2016.12.015. Epub 2016 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'Insulin resistance is a key reaction to surgery and trauma and reflects the degree of metabolic stress. With greater degree of insulin resistance the development of complications increase, in particular infectious complications. The aim of this study is to determine if robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp method. In addition inflammatory factors and clinical recovery will be measured.', 'detailedDescription': 'This is a prospective randomized controlled single center study. Primary screening will take place in the gynecological ward of Orebro University hospital according to the inclusion and exclusion criteria. 20 patients will be enrolled. All participants are randomized between robotic assisted total laparoscopic hysterectomy and total abdominal hysterectomy.\n\nThe main purpose of this study are to determine if robotic assisted laparoscopic hysterectomy induces less insulin resistance compare to abdominal hysterectomy. Both patients with benign and malignant disease are included. In addition inflammatory factors such as IL-6 and CRP are measured and clinical recovery is measured.\n\nEach patient will be studied twice using the hyperinsulinemic normoglycemic clamp, a method that now is the gold standard for determining insulin sensitivity. During the clamp insulin is infused intravenously to attain an elevation at levels seen after an abnormal meal. At the same time glucose is infused to balance the effect of insulin and to maintain normal blood glucose level. The amount of the glucose infusion needed is the level of insulin sensitivity. The clamp procedure is performed before surgery as a control measure and the morning after surgery to yield the relative change in insulin sensitivity caused by the operation (postoperative insulin resistance). Before the onset of the infusion, and after 60 minutes of steady state during insulin stimulation, blood is collected for the analysis of immune function. This is also collected 3 hours after surgery.\n\nA 6 minutes walk test is performed before surgery and the day after surgery, in order to determine a more clinical measure on recovery.\n\nIn addition demographic and clinical data are systematically collected during the hospital stay and 30 days after.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* Scheduled to total hysterectomy and/or bilateral salpingo-oophorectomy (BSOE).\n* Both malignant or benign indications\n* The operation should be technically possible to perform with laparoscopy or by abdominal incision, including approval from an anesthesiologist\n* Acceptance to participate in the study and signed written informed consent document\n* Proficiency in Swedish language\n\nExclusion Criteria:\n\n* The operation is anticipated to comprise more than the hysterectomy + BSOE\n* Diabetes mellitus\n* Severe chronic pain or massive pain medication\n* Severe inflammatory disease like active severe endometriosis or inflammatory bowel disease\n* Known severe adhesions in the abdomen\n* Contraindications on non steroidal analgesia\n* Medication with drugs or disease affecting insulin resistance for example cortisone\n* Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial\n* Severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate'}, 'identificationModule': {'nctId': 'NCT02291406', 'briefTitle': 'Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'OLL-431061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Robot assisted laparoscopic hysterectomy', 'description': 'Robot assisted laparoscopic total hysterectomy', 'interventionNames': ['Procedure: Robot assisted laparoscopic hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abdominal hysterectomy', 'description': 'Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.', 'interventionNames': ['Procedure: Abdominal hysterectomy']}], 'interventions': [{'name': 'Abdominal hysterectomy', 'type': 'PROCEDURE', 'description': 'Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.', 'armGroupLabels': ['Abdominal hysterectomy']}, {'name': 'Robot assisted laparoscopic hysterectomy', 'type': 'PROCEDURE', 'description': 'Robotic assisted total laparoscopic hysterectomy.', 'armGroupLabels': ['Robot assisted laparoscopic hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Lena Wijk, MD', 'role': 'CONTACT', 'email': 'lena.wijk@oru.se', 'phone': '+46196022040'}, {'name': 'Kerstin Nilsson, MD, PhD', 'role': 'CONTACT', 'email': 'kerstin.nilsson@orebroll.se', 'phone': '+46196022389'}], 'facility': 'Örebro Univeristy Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'centralContacts': [{'name': 'Lena Wijk, MD', 'role': 'CONTACT', 'email': 'lena.wijk@oru.se', 'phone': '+46196022040'}, {'name': 'Kerstin Nilsson, MD, PhD', 'role': 'CONTACT', 'email': 'kerstin.nilsson@orebroll.se', 'phone': '+46196022389'}], 'overallOfficials': [{'name': 'Kerstin Nilsson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden'}, {'name': 'Lena Wijk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden'}, {'name': 'Olle Ljungqvist, MD, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Kerstin Nilsson MD', 'investigatorAffiliation': 'Region Örebro County'}}}}