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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Samoilova Maternity Home
Sponsor:
Collaborator:
Northern State Medical University
Information provided by (Responsible Party):
Antypin Eduard Eduardovich, Samoilova Maternity Home
ClinicalTrials.gov Identifier:
NCT01747005
First received: November 27, 2012
Last updated: December 9, 2012
Last verified: December 2012
  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 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

serum


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)
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

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

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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Antypin Eduard Eduardovich, Anesthesiologist, Samoilova Maternity Home
ClinicalTrials.gov 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
ERAS
combined spinal-epidural anesthesia

ClinicalTrials.gov processed this record on September 18, 2014