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Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy (GERAS)

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ClinicalTrials.gov Identifier: NCT01747005
Recruitment Status : Unknown
Verified November 2015 by Antypin Eduard Eduardovich, Samoilova Maternity Home.
Recruitment status was:  Recruiting
First Posted : December 11, 2012
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Northern State Medical University
Information provided by (Responsible Party):
Antypin Eduard Eduardovich, Samoilova Maternity Home

Brief Summary:
The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.

Condition or disease
Hysterectomy

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy: A Prospective Randomized Clinical Trial.
Study Start Date : June 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Group/Cohort
Conventional therapy
ERAS
Oral intake of solid food restriction 6 hours before surgery. Oral intake clear fluids restriction 2 hours before surgery. Intravenous 5% Dextrose-500 ml 1 hour before surgery. Intravenous dexamethasone -4mg before anesthesia. Combined spinal-epidural anesthesia. Intraoperatively 10 ml/kg intravenous of crystalloids. Paracetamol intravenous 1g. Early mobilization of patient. Oral solid food intake 4 hour postoperative. Postoperative continuous epidural analgesia.



Primary Outcome Measures :
  1. Change of Serum level of IL-1beta,IL-6,CRP,Cortisol,IL-4 by immuno-ferment analysis. [ Time Frame: baseline, 24 hour post-operative and 7 days post-operative ]

Secondary Outcome Measures :
  1. Change of postoperative pain, fatigue and postoperative nausea and vomiting [ Time Frame: baseline,6,12,24,48 hour and 7 days postoperatively ]
    Postoperative pain will be assessed by visual analogue scale. Postoperative fatigue will be assessed by modified analogue scale. incidence of postoperative of nausea and vomiting


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Admitted patients in maternity home
Criteria

Inclusion Criteria:

  • Informed consent
  • Abdominal hysterectomy
  • ASA class I or II

Exclusion Criteria:

  • psychiatric disorders
  • ASA III and IV
  • Chronic inflammatory disorders
  • Pregnancy
  • Local anesthetics allergy
  • Coagulation disorders
  • patients receiving anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747005


Contacts
Contact: Eduard Ed. Antypin, MD 0079600114083 vard67@mail.ru
Contact: Ayyaz Hussain, MD 0079115848504 ayyaz@mail.ru

Locations
Russian Federation
Samoilova maternity home Recruiting
Arkhangelsk, Arkhangelskya oblast, Russian Federation, 163000
Contact: Eduard Ed Antypin, MD    0079600114083    vard67@mail.ru   
Principal Investigator: Eduard Ed Antypin, MD         
Sponsors and Collaborators
Antypin Eduard Eduardovich
Northern State Medical University

Responsible Party: Antypin Eduard Eduardovich, Anesthesiologist, Samoilova Maternity Home
ClinicalTrials.gov Identifier: NCT01747005     History of Changes
Other Study ID Numbers: SMH-0001
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Antypin Eduard Eduardovich, Samoilova Maternity Home:
abdominal hysterectomy
enhanced recovery after surgery
inflammatory response
ERAS
combined spinal-epidural anesthesia