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NCT01747005 Clinical Trial

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

Hysterectomy Clinical Trial

— GERAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01747005
Other study ID # SMH-0001
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2012
Last updated November 16, 2015
Start date June 2012
Est. completion date December 2015

Study information
Verified date November 2015
Source Samoilova Maternity Home
Contact Eduard Ed. Antypin, MD
Phone 0079600114083
Email vard67@mail.ru
Is FDA regulated No
Health authority Russia: Ministry of Healthcare
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Samoilova maternity home Arkhangelsk Arkhangelskya oblast

Sponsors (2)
Lead Sponsor Collaborator
Antypin Eduard Eduardovich Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Serum level of IL-1beta,IL-6,CRP,Cortisol,IL-4 by immuno-ferment analysis. baseline, 24 hour post-operative and 7 days post-operative No
Secondary Change of postoperative pain, fatigue and postoperative nausea and vomiting 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 No
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