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

NCT ID: NCT01747005

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hysterectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional therapy

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northern State Medical University

OTHER

Sponsor Role collaborator

Antypin Eduard Eduardovich

OTHER

Sponsor Role lead

Responsible Party

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Antypin Eduard Eduardovich

Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Samoilova maternity home

Arkhangelsk, Arkhangelskya Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Eduard Ed. Antypin, MD

Role: CONTACT

0079600114083

Ayyaz Hussain, MD

Role: CONTACT

0079115848504

Facility Contacts

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Eduard Ed Antypin, MD

Role: primary

0079600114083

Other Identifiers

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SMH-0001

Identifier Type: -

Identifier Source: org_study_id