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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02291406 |
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Date of registration:
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11/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
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Scientific title:
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Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02291406 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Lena Wijk, MD |
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Address:
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Telephone:
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+46196022040 |
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Email:
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lena.wijk@oru.se |
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Affiliation:
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Name:
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Kerstin Nilsson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden |
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Name:
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Olle Ljungqvist, MD, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden. |
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Name:
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Lena Wijk, MD |
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Address:
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Telephone:
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+46196022040 |
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Email:
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lena.wijk@oru.se |
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Affiliation:
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Name:
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Lena Wijk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Over 18 years of age
- Scheduled to total hysterectomy and/or bilateral salpingo-oophorectomy (BSOE).
- Both malignant or benign indications
- The operation should be technically possible to perform with laparoscopy or by
abdominal incision, including approval from an anesthesiologist
- Acceptance to participate in the study and signed written informed consent document
- Proficiency in Swedish language
Exclusion Criteria:
- The operation is anticipated to comprise more than the hysterectomy + BSOE
- Diabetes mellitus
- Severe chronic pain or massive pain medication
- Severe inflammatory disease like active severe endometriosis or inflammatory bowel
disease
- Known severe adhesions in the abdomen
- Contraindications on non steroidal analgesia
- Medication with drugs or disease affecting insulin resistance for example cortisone
- Mentally disabled women who cannot fill in the questionnaires or understand the
consequences of participating in a trial
- Severe psychiatric disease or on medication for psychiatric disease so that the
physician consider participation in the trial inappropriate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Intervention(s)
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Procedure: Abdominal hysterectomy
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Procedure: Robot assisted laparoscopic hysterectomy
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Primary Outcome(s)
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Insulin resistance
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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complications
[Time Frame: 4 weeks]
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6 minutes walk test
[Time Frame: 3 weeks]
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postoperative outcomes
[Time Frame: 4 weeks]
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Changes in biomarkers of inflammation and the immune system.
[Time Frame: 3 weeks]
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Secondary ID(s)
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OLL-431061
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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