Clinical trial NCT02291406: Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
Official title: Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Keywords: Hysterectomy
Insulin resistance
Metabolism
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Insulin resistance
timeFrame: 3 weeks
Secondary outcomes:
measure: Changes in biomarkers of inflammation and the immune system.
timeFrame: 3 weeks
measure: 6 minutes walk test
timeFrame: 3 weeks
measure: postoperative outcomes
timeFrame: 4 weeks
measure: complications
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro Univeristy Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden
name: Kerstin Nilsson, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden
name: Lena Wijk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.
name: Olle Ljungqvist, MD, Prof
role: STUDY_CHAIR
References:
citation: 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.