Patient SatisfactionNCT05931796
Enhanced vs Conventional Recovery After Breast Surgery
A study testing NON-ERAS pathway and ERAS pathway in people with Patient Satisfaction, run by Amal Gouda Elsayed Safan at 1 site in Egypt.
Trial summary
the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- NON-ERAS pathway and ERAS pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 25 Jan 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Age: 20-60 years.
- Adequate cognitive state (able to understand and collaborate)
- American society of anesthesia (ASA) I, II
Who cannot join
- Patients who are:
- Uncooperative.
- Having allergy to any of the study drugs.
- Known abuse of alcohol or medication.
- Having Local infection at the site of injection or systemic infection.
- Pregnancy.
- With coagulation disorders.
- Any complicated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery
the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.
Read the detailed description
Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway
- Conditions
- Patient Satisfaction
- Being tested
- NON-ERAS pathway, ERAS pathway
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NON-ERAS pathwayOther
All patients received best of care practice, with standardization of preoperative and postoperative care
ERAS pathwayOther
ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care Receives: Other: NON-ERAS pathway |
| Group B | Active comparator | ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions . Receives: Other: ERAS pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy.
visual analogue scale VAS Score (a scale from 0 to 10 where 0 is interpreted as no pain, 1- 4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)' every 1hour for the first 8hours' then every 3hours for the remaining 24 hours.
Measured: 48 hours
Secondary outcomes (1)
Time of first ambulation
hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start10 Mar 2023
- Primary completion10 Sep 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amal Gouda Elsayed Safan
- Sponsor type
- University, hospital or other
- Collaborators
- Mahmoud Saeed Ebaid
- Responsible party
- Sponsor-investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- Mahmoud Saeed Ebaid, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931796
- Sponsor's protocol ID
- 3/2023ANET45
- Status last verified
- Jan 2024
- First submitted
- 2 Jun 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT05931796
- Acronym / sponsor ID
- 3/2023ANET45
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Amal Gouda Elsayed SafanUniversity, hospital or other
- Collaborators
- Mahmoud Saeed Ebaid
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 5 Jul 2023 (actual)
- 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 investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.
Detailed description
Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: NON-ERAS pathwayNON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care |
| Group B | Active comparator | Other: ERAS pathwayERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Age: 20-60 years.
Key exclusion criteria (8 listed)
- Patients who are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NON-ERAS pathwayAll patients received best of care practice, with standardization of preoperative and postoperative care | Other | Group A |
| ERAS pathwayERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions . | Other | Group B |
Primary outcome
This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy.
Time frame: 48 hours
visual analogue scale VAS Score (a scale from 0 to 10 where 0 is interpreted as no pain, 1- 4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)' every 1hour for the first 8hours' then every 3hours for the remaining 24 hours.
1 secondary outcome
Time of first ambulation
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Mahmoud Saeed Ebaid principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NON-ERAS pathway and ERAS pathway in people with Patient Satisfaction, run by Amal Gouda Elsayed Safan at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 26 Jan 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy. (time frame: 48 hours). 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 26 Jan 2024.