HysterectomyGERASNCT01747005
Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy
An observational study of Hysterectomy, run by Antypin Eduard Eduardovich at 1 site in Russia.
Trial summary
The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hysterectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Admitted patients in maternity home
Who may be able to join
- Informed consent
- Abdominal hysterectomy
- ASA class I or II
Who cannot join
- psychiatric disorders
- ASA III and IV
- Chronic inflammatory disorders
- Pregnancy
- Local anesthetics allergy
- Coagulation disorders
- patients receiving anticoagulants
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Samoilova maternity home
Arkhangelsk, Arkhangelskya Oblast, 163000
Eduard Ed Antypin, MD, 0079600114083, vard67@mail.ru
Eduard Ed Antypin, MD
About this study
Official title: 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.
- Conditions
- Hysterectomy
- Keywords
- abdominal hysterectomy, enhanced recovery after surgery, inflammatory response, ERAS, combined spinal-epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Not described | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change of Serum level of IL-1beta,IL-6,CRP,Cortisol,IL-4 by immuno-ferment analysis.
Measured: baseline, 24 hour post-operative and 7 days post-operative
Secondary outcomes (1)
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
Measured: baseline,6,12,24,48 hour and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antypin Eduard Eduardovich
- Sponsor type
- University, hospital or other
- Collaborators
- Northern State Medical University
- Responsible party
- Sponsor-investigator, Antypin Eduard Eduardovich, Samoilova Maternity Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747005
- Sponsor's protocol ID
- SMH-0001
- Acronym
- GERAS
- Status last verified
- Nov 2015
- First submitted
- 27 Nov 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy: A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01747005
- Acronym / sponsor ID
- GERAS / SMH-0001
- Conditions
- Hysterectomy
- Keywords
- abdominal hysterectomy, enhanced recovery after surgery, inflammatory response, ERAS, combined spinal-epidural anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Antypin Eduard EduardovichUniversity, hospital or other
- Collaborators
- Northern State Medical University
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients in maternity home
Key inclusion criteria (3 listed)
- Informed consent
- Abdominal hysterectomy
- ASA class I or II
Key exclusion criteria (7 listed)
- psychiatric disorders
- ASA III and IV
- Chronic inflammatory disorders
- Pregnancy
- Local anesthetics allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Change of postoperative pain, fatigue and postoperative nausea and vomiting
Time frame: baseline,6,12,24,48 hour and 7 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Antypin Eduard Eduardovich at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduard Ed. Antypin, MD (0079600114083, vard67@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.