Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Samoilova Maternity Home.
Recruitment status was  Recruiting
Northern State Medical University
Information provided by (Responsible Party):
Antypin Eduard Eduardovich, Samoilova Maternity Home Identifier:
First received: November 27, 2012
Last updated: December 9, 2012
Last verified: December 2012

The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Conventional therapy
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Admitted patients in maternity home


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01747005

Contact: Eduard Ed. Antypin, MD 0079600114083
Contact: Ayyaz Hussain, MD 0079115848504

Russian Federation
Samoilova maternity home Recruiting
Arkhangelsk, Arkhangelskya oblast, Russian Federation, 163000
Contact: Eduard Ed Antypin, MD    0079600114083   
Principal Investigator: Eduard Ed Antypin, MD         
Sponsors and Collaborators
Antypin Eduard Eduardovich
Northern State Medical University
  More Information

No publications provided

Responsible Party: Antypin Eduard Eduardovich, Anesthesiologist, Samoilova Maternity Home Identifier: NCT01747005     History of Changes
Other Study ID Numbers: SMH-0001
Study First Received: November 27, 2012
Last Updated: December 9, 2012
Health Authority: Russia: Ministry of Healthcare

Keywords provided by Samoilova Maternity Home:
abdominal hysterectomy
enhanced recovery after surgery
inflammatory response
combined spinal-epidural anesthesia processed this record on March 03, 2015