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

Insulin Resistance Clinical Trial

Official title:

Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291406
• Other study ID #: OLL-431061
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2014
• Last updated: November 13, 2014
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2014
• Source: University Hospital Orebro
• Contact: Lena Wijk, MD
• Phone: +46196022040
• Email: lena.wijk[@]oru.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Procedure:
• Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
• Robot assisted laparoscopic hysterectomy
Robotic assisted total laparoscopic hysterectomy.

Locations

Country	Name	City	State
Sweden	Örebro Univeristy Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	6 minutes walk test	Measured before surgery and on the day after surgery 25-26 hours after surgery.	3 weeks	No
Secondary	postoperative outcomes	Postoperative outcome is registered systematically according to the ERAS Society register.	4 weeks	No
Secondary	complications	Adverse events are registered systematically from start of anesthesia to 30 days after surgery	4 weeks	No