Insulin ResistanceNCT02291406
Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
A study testing Abdominal hysterectomy and Robot assisted laparoscopic hysterectomy in people with Insulin Resistance, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Abdominal hysterectomy and Robot assisted laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Örebro Univeristy Hospital
Örebro
Lena Wijk, MD, +46196022040, lena.wijk@oru.se
Kerstin Nilsson, MD, PhD, +46196022389, kerstin.nilsson@orebroll.se
About this study
Official title: Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Abdominal hysterectomy, Robot assisted laparoscopic hysterectomy
- Keywords
- Hysterectomy, Insulin resistance, Metabolism
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal hysterectomyProcedure or surgery
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
Robot assisted laparoscopic hysterectomyProcedure or surgery
Robotic assisted total laparoscopic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted laparoscopic hysterectomy | Active comparator | Robot assisted laparoscopic total hysterectomy Receives: Procedure: Robot assisted laparoscopic hysterectomy |
| Abdominal hysterectomy | Active comparator | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision. Receives: Procedure: Abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 3 weeks
6 minutes walk test
Measured before surgery and on the day after surgery 25-26 hours after surgery.
Measured: 3 weeks
postoperative outcomes
Postoperative outcome is registered systematically according to the ERAS Society register.
Measured: 4 weeks
complications
Adverse events are registered systematically from start of anesthesia to 30 days after surgery
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerstin Nilsson MD, Region Örebro County
- Investigators
- Kerstin Nilsson, MD, PhD, Study chair, Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, SwedenLena Wijk, MD, Principal investigator, Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, SwedenOlle Ljungqvist, MD, Prof, Study chair, Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291406
- Sponsor's protocol ID
- OLL-431061
- Status last verified
- Oct 2014
- First submitted
- 11 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28043722
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02291406
- Acronym / sponsor ID
- OLL-431061
- Conditions
- Insulin Resistance
- Keywords
- Hysterectomy, Insulin resistance, Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted laparoscopic hysterectomy | Active comparator | Procedure: Robot assisted laparoscopic hysterectomyRobot assisted laparoscopic total hysterectomy |
| Abdominal hysterectomy | Active comparator | Procedure: Abdominal hysterectomyStandard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal hysterectomyStandard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision. | Procedure or surgery | Abdominal hysterectomy |
| Robot assisted laparoscopic hysterectomyRobotic assisted total laparoscopic hysterectomy. | Procedure or surgery | Robot assisted laparoscopic hysterectomy |
Primary outcome
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.
4 secondary outcomes
Changes in biomarkers of inflammation and the immune system.
Time frame: 3 weeks
6 minutes walk test
Time frame: 3 weeks
postoperative outcomes
Time frame: 4 weeks
complications
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Derived from this study: PubMed 28043722Wijk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Nilsson, MD, PhD study chair
Department of Obstetrics and Gynecology, Örebro University Hospital, School of medicine, Örebro University, Sweden
Lena Wijk, MD principal investigator
Department of Obstetrics and Gynecology, Örebro University Hospital, School of Health and Medical Sciences, Örebro University, Sweden
Olle Ljungqvist, MD, Prof study chair
Department of Surgery, Örebro University Hospital, School of Health and Medical Sciences Örebro University, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal hysterectomy and Robot assisted laparoscopic hysterectomy in people with Insulin Resistance, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Wijk, MD (+46196022040, lena.wijk@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.