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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Antypin Eduard Eduardovich, Samoilova Maternity Home.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747005
First Posted: December 11, 2012
Last Update Posted: November 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Northern State Medical University
Information provided by (Responsible Party):
Antypin Eduard Eduardovich, Samoilova Maternity Home
  Purpose
The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.

Condition
Hysterectomy

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Antypin Eduard Eduardovich, Samoilova Maternity Home:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Antypin Eduard Eduardovich, Anesthesiologist, Samoilova Maternity Home
ClinicalTrials.gov Identifier: NCT01747005     History of Changes
Other Study ID Numbers: SMH-0001
First Submitted: November 27, 2012
First Posted: December 11, 2012
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