Obesity, MorbidNCT05790317
Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery
A study testing Surgical Procedure with ERAS Protocol in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate, Obesity Adult Onset
- What is being tested?
- Surgical Procedure with ERAS Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 10 Feb 2023
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-65 years of age who underwent bariatric surgery
- Open to communication and collaborative,
- Patients who volunteered to take part in the study
Who cannot join
- Patients with major visual, hearing and speech impairments
- Patients who want to withdraw from the study at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir university
Istanbul, Besiktas, 34349
About this study
Official title: Comparıson Of The Effects Of The Eras Protocol Applıcatıon And The Effects Of The Tradıtıonal Method On The In Obesıty Surgery
This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence.
Read the detailed description
The population of the study consisted of 700 patients over the age of 18 who underwent bariatric surgery in the Obesity Surgery Clinic of a private hospital in 2022. The sample of the study included 128 patients who were willing to undergo bariatric surgery between April 15-July 31, 2022, were in compliance with the research criteria and were voluntarily over the age of 18, 64 in the control and 64 in the experimental group. 128 patients in the sample were assigned to 2 groups using a computer program that generates random numbers. For the purpose of the research, groups were coded as groups A and B, and two different surgical preparations and surgical procedures were applied to the patients in the group. The effects of two different surgical method preparations and the surgical process on the patient's recovery were compared. In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Accelerated Care Protocol. Permission was obtained for the scales, and the content validity calculation of the Postoperative Evaluation Form was made in line with the evaluations of the field experts consisting of physicians and nurses experienced in the ERAS Rapid Care Protocol. The data were analyzed in SPSS Package Program. While calculating frequency, percentage and standard deviation in the evaluation of the data, comparisons between groups were made with the independent sample t-test, and p≤ 0.05 was taken as the significance value of the findings.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate, Obesity Adult Onset, Obesity Associated Disorder, Diabetes, Nausea
- Being tested
- Surgical Procedure with ERAS Protocol
- Keywords
- DVT, BKÖİ, DSÖ, ASA, BKI, BPD, CVI, DMAH, ERAS, FTS, IASMEN, MBT, LSG
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Nausea, Pain, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Procedure with ERAS ProtocolProcedure or surgery
Also called Fast Track Surgery
It covers the period before, during and after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Procedure with ERAS Protocol | Experimental | ERAS Maintenance Protocol The basic philosophy of the ERAS Protocol is to reduce metabolic stress due to surgical trauma, and to return to normal activity as soon as possible by supporting the normalization of functions in a short time. ERAS protocols are a protocol consisting of a total of 24 items covering the perioperative period of a patient, which starts in the outpatient clinic in the preoperative period and ends at home with discharge. includes applications. Elements of this preparation and treatment method, which is different from the traditional, were applied to our patients in this group before (11), during the operation (6) and after the operation (7). In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Care Protocol. Receives: Procedure: Surgical Procedure with ERAS Protocol |
| Surgery Procedure with the traditional method | No intervention | ItThe group that underwent surgery with the traditional method is the control group. The surgical procedure preparation procedure in the institution where the study was conducted was not exceeded. The data in the control group were collected with the patient information form, the Postoperative Evaluation Form to evaluate the symptoms after the surgical intervention, the McGill Pain Scale Short Form, the Rhodes Nausea-Vomiting Regurgitation Index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and level of postoperative pain
In the sample calculation of the research; To measure the significant differences between independent groups, a minimum of 128 samples is required (64 for each group) in order to determine 80% statistical power and α = 0.05 significance and d = 0.50 effect size in the t-test to be performed.
In order to evaluate the effect of the post-operative accelerated recovery (ERAS) protocol on the patient recovery process, 128 patients who applied to the hospital for bariatric surgery between April and June 2022 were included in the study. 64 patients were divided into groups as the ERAS Protocol group and 64 patients as the control group.
Postoperative pain status was evaluated with the McGill Pain Questionnaire (SF-MPQ). In determining the severity of pain, the McGill Pain Scale Numerical Evaluation was evaluated as 0-10 points, 0 no pain, 10 unbearable pain. A score of 4 or less for patients meant less pain.
Measured: 3 days
Presence of post-operative nausea, vomiting and retching
Postoperative nausea, vomiting and retching were evaluated with the "Rhodes Nausea-Vomiting Rectal Index". According to the sub-dimensions of the scale, each of the symptoms of nausea, vomiting and retching was scored in the range of 0-12 points. 0 meant the least distress - 12 meant the most distress.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start14 Feb 2022
- Primary completion31 Jul 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylul Tulay Aykul, Bahçeşehir University
- Investigators
- Eylül Tülay Aykul, master, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790317
- Sponsor's protocol ID
- Bau-bahcesehir university
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson Of The Effects Of The Eras Protocol Applıcatıon And The Effects Of The Tradıtıonal Method On The In Obesıty Surgery
- ClinicalTrials.gov ID
- NCT05790317
- Acronym / sponsor ID
- Bau-bahcesehir university
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate, Obesity Adult Onset, Obesity Associated Disorder, Diabetes, Nausea
- Keywords
- DVT, BKÖİ, DSÖ, ASA, BKI, BPD, CVI, DMAH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 30 Mar 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.
This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence.
Detailed description
The population of the study consisted of 700 patients over the age of 18 who underwent bariatric surgery in the Obesity Surgery Clinic of a private hospital in 2022. The sample of the study included 128 patients who were willing to undergo bariatric surgery between April 15-July 31, 2022, were in compliance with the research criteria and were voluntarily over the age of 18, 64 in the control and 64 in the experimental group. 128 patients in the sample were assigned to 2 groups using a computer program that generates random numbers. For the purpose of the research, groups were coded as groups A and B, and two different surgical preparations and surgical procedures were applied to the patients in the group. The effects of two different surgical method preparations and the surgical process on the patient's recovery were compared. In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Accelerated Care Protocol. Permission was obtained for the scales, and the content validity calculation of the Postoperative Evaluation Form was made in line with the evaluations of the field experts consisting of physicians and nurses experienced in the ERAS Rapid Care Protocol. The data were analyzed in SPSS Package Program. While calculating frequency, percentage and standard deviation in the evaluation of the data, comparisons between groups were made with the independent sample t-test, and p≤ 0.05 was taken as the significance value of the findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Procedure with ERAS Protocol | Experimental | Procedure: Surgical Procedure with ERAS ProtocolERAS Maintenance Protocol The basic philosophy of the ERAS Protocol is to reduce metabolic stress due to surgical trauma, and to return to normal activity as soon as possible by supporting the normalization of functions in a short time. ERAS protocols are a protocol consisting of a total of 24 items covering the perioperative period of a patient, which starts in the outpatient clinic in the preoperative period and ends at home with discharge. includes applications. Elements of this preparation and treatment method, which is different from the traditional, were applied to our patients in this group before (11), during the operation (6) and after the operation (7). In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Care Protocol. |
| Surgery Procedure with the traditional method | No intervention | –ItThe group that underwent surgery with the traditional method is the control group. The surgical procedure preparation procedure in the institution where the study was conducted was not exceeded. The data in the control group were collected with the patient information form, the Postoperative Evaluation Form to evaluate the symptoms after the surgical intervention, the McGill Pain Scale Short Form, the Rhodes Nausea-Vomiting Regurgitation Index. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-65 years of age who underwent bariatric surgery
- Open to communication and collaborative,
- Patients who volunteered to take part in the study
Key exclusion criteria (2 listed)
- Patients with major visual, hearing and speech impairments
- Patients who want to withdraw from the study at any stage of the study
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 |
|---|---|---|
| Surgical Procedure with ERAS ProtocolAlso: Fast Track SurgeryIt covers the period before, during and after the surgery. | Procedure or surgery | Surgical Procedure with ERAS Protocol |
Primary outcome
Presence and level of postoperative pain
Time frame: 3 days
In the sample calculation of the research; To measure the significant differences between independent groups, a minimum of 128 samples is required (64 for each group) in order to determine 80% statistical power and α = 0.05 significance and d = 0.50 effect size in the t-test to be performed. In order to evaluate the effect of the post-operative accelerated recovery (ERAS) protocol on the patient recovery process, 128 patients who applied to the hospital for bariatric surgery between April and June 2022 were included in the study. 64 patients were divided into groups as the ERAS Protocol group and 64 patients as the control group. Postoperative pain status was evaluated with the McGill Pain Questionnaire (SF-MPQ). In determining the severity of pain, the McGill Pain Scale Numerical Evaluation was evaluated as 0-10 points, 0 no pain, 10 unbearable pain. A score of 4 or less for patients meant less pain.
Presence of post-operative nausea, vomiting and retching
Time frame: 3 days
Postoperative nausea, vomiting and retching were evaluated with the "Rhodes Nausea-Vomiting Rectal Index". According to the sub-dimensions of the scale, each of the symptoms of nausea, vomiting and retching was scored in the range of 0-12 points. 0 meant the least distress - 12 meant the most distress.
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 30 Mar 2023.
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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.
Eylül Tülay Aykul, master principal investigator
Bahçeşehir 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 Surgical Procedure with ERAS Protocol in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 2 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 30 Mar 2023. 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 Turkey (Türkiye). 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?
Presence and level of postoperative pain (time frame: 3 days). The study lists 2 primary outcomes in all. 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 30 Mar 2023.