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

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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

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
  • 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.
  • 6 minutes walk test [ Time Frame: 3 weeks ]
    Measured before surgery and on the day after surgery 25-26 hours after surgery.
  • postoperative outcomes [ Time Frame: 4 weeks ]
    Postoperative outcome is registered systematically according to the ERAS Society register.
  • complications [ Time Frame: 4 weeks ]
    Adverse events are registered systematically from start of anesthesia to 30 days after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
Official Title  ICMJE Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance
Intervention  ICMJE
  • Procedure: Abdominal hysterectomy
    Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
  • Procedure: Robot assisted laparoscopic hysterectomy
    Robotic assisted total laparoscopic hysterectomy.
Study Arms  ICMJE
  • Active Comparator: Robot assisted laparoscopic hysterectomy
    Robot assisted laparoscopic total hysterectomy
    Intervention: Procedure: Robot assisted laparoscopic hysterectomy
  • Active Comparator: Abdominal hysterectomy
    Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
    Intervention: Procedure: Abdominal hysterectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291406
Other Study ID Numbers  ICMJE OLL-431061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kerstin Nilsson MD, Region Örebro County
Study Sponsor  ICMJE Region Örebro County
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Region Örebro County
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP