Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery

Bahçeşehir University

Status: Completed

Conditions: ERAS; Nausea; Bariatric Surgery Candidate; Pain, Postoperative; Ache; Obesity Associated Disorder; Obesity, Morbid; Post Procedural Discharge; Diabetes; Postoperative Nausea and Vomiting; Postoperative Nausea; DVT; Obesity Adult Onset

Treatments: Procedure: Surgical Procedure with ERAS Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05790317

Bau-bahcesehir university

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Surgical Procedure with ERAS Protocol

Experimental group

Description:

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.

Treatment:

Procedure: Surgical Procedure with ERAS Protocol

Surgery Procedure with the traditional method

No Intervention group

Description:

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.