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

NCT02291406 | Unknown DMC

• 1 other identifier: OLL-431061
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Hysterectomy; Insulin resistance; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes in biomarkers of inflammation and the immune system.

  3 weeks

• 6 minutes walk test

  3 weeks

• postoperative outcomes

  4 weeks

• complications

  4 weeks

Study Arms (2)

Robot assisted laparoscopic hysterectomy

ACTIVE COMPARATOR

Robot assisted laparoscopic total hysterectomy

Procedure: Robot assisted laparoscopic hysterectomy

Abdominal hysterectomy

ACTIVE COMPARATOR

Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.

Procedure: Abdominal hysterectomy

Interventions

Abdominal hysterectomy PROCEDURE

Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.

Abdominal hysterectomy

Robot assisted laparoscopic hysterectomy PROCEDURE

Robotic assisted total laparoscopic hysterectomy.

Robot assisted laparoscopic hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro Univeristy Hospital

Örebro, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 28043722 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Olle Ljungqvist, MD, Prof

  Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.

  STUDY CHAIR

Central Study Contacts

Lena Wijk, MD

CONTACT

+46196022040; lena.wijk@oru.se

Kerstin Nilsson, MD, PhD

CONTACT

+46196022389; kerstin.nilsson@orebroll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 14, 2014

Record last verified: 2014-10

Locations

SE (1)