Status:
UNKNOWN
Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery
Lead Sponsor:
Region Örebro County
Conditions:
Insulin Resistance
Eligibility:
FEMALE
18+ years
Phase:
NA
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 particul...
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 crit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02291406
Start Date
October 1 2014
End Date
July 1 2015
Last Update
November 14 2014
Active Locations (1)
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1
Örebro Univeristy Hospital
Örebro, Sweden