NCT01747005

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3.5 years

First QC Date

November 27, 2012

Last Update Submit

November 16, 2015

Conditions

Hysterectomy

Keywords

abdominal hysterectomyenhanced recovery after surgeryinflammatory responseERAScombined spinal-epidural anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change of postoperative pain, fatigue and postoperative nausea and vomiting

    baseline,6,12,24,48 hour and 7 days postoperatively

Study Arms (2)

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 Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Admitted patients in maternity home

You may qualify if:

  • Informed consent
  • Abdominal hysterectomy
  • ASA class I or II

You may not qualify if:

  • psychiatric disorders
  • ASA III and IV
  • Chronic inflammatory disorders
  • Pregnancy
  • Local anesthetics allergy
  • Coagulation disorders
  • patients receiving anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samoilova maternity home

Arkhangelsk, Arkhangelskya Oblast, 163000, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Central Study Contacts

Eduard Ed. Antypin, MD

CONTACT

0079600114083vard67@mail.ru

Ayyaz Hussain, MD

CONTACT

0079115848504ayyaz@mail.ru

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 11, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

RU(1)