Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291406
Recruitment Status : Unknown
Verified October 2014 by Kerstin Nilsson MD, Region Örebro County.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Kerstin Nilsson MD, Region Örebro County

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Procedure: Abdominal hysterectomy Procedure: Robot assisted laparoscopic hysterectomy Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
Study Start Date : October 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Procedure: Robot assisted laparoscopic hysterectomy
Robotic assisted total laparoscopic hysterectomy.

Active Comparator: Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
Procedure: Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.




Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. Changes in biomarkers of inflammation and the immune system. [ Time Frame: 3 weeks ]
    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.

  2. 6 minutes walk test [ Time Frame: 3 weeks ]
    Measured before surgery and on the day after surgery 25-26 hours after surgery.

  3. postoperative outcomes [ Time Frame: 4 weeks ]
    Postoperative outcome is registered systematically according to the ERAS Society register.

  4. complications [ Time Frame: 4 weeks ]
    Adverse events are registered systematically from start of anesthesia to 30 days after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291406


Contacts
Layout table for location contacts
Contact: Lena Wijk, MD +46196022040 lena.wijk@oru.se
Contact: Kerstin Nilsson, MD, PhD +46196022389 kerstin.nilsson@orebroll.se

Locations
Layout table for location information
Sweden
Örebro Univeristy Hospital Recruiting
Örebro, Sweden
Contact: Lena Wijk, MD    +46196022040    lena.wijk@oru.se   
Contact: Kerstin Nilsson, MD, PhD    +46196022389    kerstin.nilsson@orebroll.se   
Sponsors and Collaborators
Region Örebro County
Investigators
Layout table for investigator information
Study Chair: Kerstin Nilsson, MD, PhD Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden
Principal Investigator: Lena Wijk, MD Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden
Study Chair: Olle Ljungqvist, MD, Prof Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kerstin Nilsson MD, PhD, Region Örebro County
ClinicalTrials.gov Identifier: NCT02291406    
Other Study ID Numbers: OLL-431061
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: October 2014
Keywords provided by Kerstin Nilsson MD, Region Örebro County:
Hysterectomy
Insulin resistance
Metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases