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

November 16, 2015 updated by: Antypin Eduard Eduardovich

Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy: A Prospective Randomized Clinical Trial.

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eduard Ed. Antypin, MD
  • Phone Number: 0079600114083
  • Email: vard67@mail.ru

Study Contact Backup

  • Name: Ayyaz Hussain, MD
  • Phone Number: 0079115848504
  • Email: ayyaz@mail.ru

Study Locations

  • Russian Federation
    • Arkhangelskya oblast
      • Arkhangelsk, Arkhangelskya oblast, Russian Federation, 163000
        • Recruiting
        • Samoilova maternity home
        • Contact:
          • Eduard Ed Antypin, MD
          • Phone Number: 0079600114083
          • Email: vard67@mail.ru
        • Principal Investigator:
          • Eduard Ed Antypin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Admitted patients in maternity home

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline, 24 hour post-operative and 7 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline,6,12,24,48 hour and 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antypin Eduard Eduardovich

Collaborators

Northern State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

December 9, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMH-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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