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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted laparoscopic hysterectomy | Active Comparator | Robot assisted laparoscopic total hysterectomy |
|
| Abdominal hysterectomy | Active Comparator | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal hysterectomy | Procedure | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in biomarkers of inflammation and the immune system. | 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. | 3 weeks |
| 6 minutes walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena Wijk, MD | Contact | +46196022040 | lena.wijk@oru.se | |
| Kerstin Nilsson, MD, PhD | Contact | +46196022389 | kerstin.nilsson@orebroll.se |
| Name | Affiliation | Role |
|---|---|---|
| Kerstin Nilsson, MD, PhD | Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden | Study Chair |
| Lena Wijk, MD | Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro Univeristy Hospital | Recruiting | Örebro | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28043722 | Derived | 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. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Robot assisted laparoscopic hysterectomy | Procedure | Robotic assisted total laparoscopic hysterectomy. |
|
Measured before surgery and on the day after surgery 25-26 hours after surgery. |
| 3 weeks |
| postoperative outcomes | Postoperative outcome is registered systematically according to the ERAS Society register. | 4 weeks |
| complications | Adverse events are registered systematically from start of anesthesia to 30 days after surgery | 4 weeks |
| Principal Investigator |
| Olle Ljungqvist, MD, Prof | Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden. | Study Chair |