Diabetes Clinical Trial
Official title:
Comparıson Of The Effects Of The Eras Protocol Applıcatıon And The Effects Of The Tradıtıonal Method On The In Obesıty Surgery
Verified date | March 2023 |
Source | Bahçesehir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | February 10, 2023 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - 18-65 years of age who underwent bariatric surgery - Open to communication and collaborative, - Patients who volunteered to take part in the study Exclusion Criteria: - Patients with major visual, hearing and speech impairments - Patients who want to withdraw from the study at any stage of the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Bahcesehir university | Istanbul | Besiktas |
Lead Sponsor | Collaborator |
---|---|
Bahçesehir University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 a = 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. |
3 days | |
Primary | 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. | 3 days |
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