Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
NCT ID: NCT02291406
Last Updated: 2014-11-14
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
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-10-31
2015-07-31
Brief Summary
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Detailed Description
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The 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.
Each 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.
A 6 minutes walk test is performed before surgery and the day after surgery, in order to determine a more clinical measure on recovery.
In addition demographic and clinical data are systematically collected during the hospital stay and 30 days after.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Robot assisted laparoscopic hysterectomy
Robotic assisted total laparoscopic hysterectomy.
Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
Interventions
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Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
Robot assisted laparoscopic hysterectomy
Robotic assisted total laparoscopic hysterectomy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Region Örebro County
OTHER
Responsible Party
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Kerstin Nilsson MD
PhD
Principal Investigators
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Kerstin Nilsson, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden
Lena Wijk, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden
Olle Ljungqvist, MD, Prof
Role: STUDY_CHAIR
Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.
Locations
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Örebro Univeristy Hospital
Örebro, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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OLL-431061
Identifier Type: -
Identifier Source: org_study_id