The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

August 10, 2019 updated by: Luo Zhang, Beijing Tongren Hospital

Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery

Enhanced recovery after surgery (ERAS) protocols have been widely applied during perioperative periods for different diseases, there are few reports of ERAS in patients undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the benefits of ERAS protocol compared to traditional care following ESS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has CRSwNP need endoscopic sinus surgery for treatment.

Exclusion Criteria:

  • age under 18 years
  • pregnant
  • ASA grade IV
  • received oral or topical steroids within 4 weeks preceding surgery
  • had previous ESS history
  • intolerant to NSAIDS
  • comorbidity of severe mental disease
  • not compliant with therapy.

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ERAS with postoperative intravenous Flubiprofen Axetil
The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.
Drug: Flurbiprofen Axetil
One kind of NSAIDs, 200mg for 48 hours after surgery.
Behavioral: Extended perioperative counseling
The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.
Behavioral: Shorter fasting food and water time before surgery
The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery
Experimental: ERAS with analgesia pump
The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.
Behavioral: Extended perioperative counseling
The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.
Behavioral: Shorter fasting food and water time before surgery
The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery
Drug: Sufentanil
One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
Experimental: Traditional care with Flubiprofen Axetil
Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.
Drug: Flurbiprofen Axetil
One kind of NSAIDs, 200mg for 48 hours after surgery.
Behavioral: Conventional perioperative counseling
THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
Behavioral: Regular fasting food and water time before surgery
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
Experimental: Traditional care with analgesia pump
Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.
Drug: Sufentanil
One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
Behavioral: Conventional perioperative counseling
THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
Behavioral: Regular fasting food and water time before surgery
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
Placebo Comparator: traditional care without postoperative intravenous analgesia.
Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Intravenous saline with necessary oral analgesic for postoperative pain management.
Behavioral: Conventional perioperative counseling
THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
Behavioral: Regular fasting food and water time before surgery
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain management
Time Frame: at 2 hours after surgery
The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 2 hours after surgery
Pain management
Time Frame: at 6 hours after surgery
The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 6 hours after surgery
Pain management
Time Frame: at 24 hours after surgery
The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 24 hours after surgery
Pain management
Time Frame: at 48 hours after surgery
The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hunger scores
Time Frame: at 5 minutes before surgery start
The hunger scores before surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 5 minutes before surgery start
Self-rating Anxiety Scale
Time Frame: at baseline and 72 hours after surgery
The anxiety scale was measured by Self-rating Anxiety Scale (SAS) questionaire. The SAS questionaire contain 20 items and each item is range 1 to 4 points. The total scores is reported, which range 20 to 80 points and higher scores mean that more anxiety.
at baseline and 72 hours after surgery
thirst scores
Time Frame: at 5 minutes before surgery start
The thirst scores before surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.
at 5 minutes before surgery start
General comfort scores
Time Frame: at baseline and 72 hours after surgery
Kolcaba General Comfort Questionnaire (GCQ) was assessed to evaluate the quality of life of patients. The GCQ questionaire contain 28 items and each item is range 1 to 4 points. The total scores is reported, which range 28 to 112 points and higher scores mean that feel more comfort.
at baseline and 72 hours after surgery
quality of sleeping
Time Frame: at baseline and 72 hours after surgery
Medical Outcomes Study Sleep Scale (MOS-SS) was assessed to evaluate the quality of sleep of patients. The MOS-SS questionaire contain 7 items, including sleep disturbance, snoring, awakening short of breath or with headache, sleep adequacy, daytime somnolence and amount of sleeping.
at baseline and 72 hours after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR-ERAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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