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

Primary Purpose

Obesity, Morbid, Bariatric Surgery Candidate, Obesity Adult Onset

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgical Procedure with ERAS Protocol
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Morbid focused on measuring DVT, BKÖİ, DSÖ, ASA, BKI, BPD, CVI, DMAH, ERAS, FTS, IASMEN, MBT, LSG

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Bahcesehir university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical Procedure with ERAS Protocol

Surgery Procedure with the traditional method

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2022
Last Updated
March 16, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05790317
Brief Title
Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery
Official Title
Comparıson Of The Effects Of The Eras Protocol Applıcatıon And The Effects Of The Tradıtıonal Method On The In Obesıty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Bariatric Surgery Candidate, Obesity Adult Onset, Obesity Associated Disorder, Diabetes, Nausea, Ache, Pain, Postoperative, Postoperative Nausea, Postoperative Nausea and Vomiting, Post Procedural Discharge, ERAS, DVT
Keywords
DVT, BKÖİ, DSÖ, ASA, BKI, BPD, CVI, DMAH, ERAS, FTS, IASMEN, MBT, LSG

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Procedure with ERAS Protocol
Arm Type
Experimental
Arm 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.
Arm Title
Surgery Procedure with the traditional method
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Surgical Procedure with ERAS Protocol
Other Intervention Name(s)
Fast Track Surgery
Intervention Description
It covers the period before, during and after the surgery.
Primary Outcome Measure Information:
Title
Presence and level of postoperative pain
Description
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.
Time Frame
3 days
Title
Presence of post-operative nausea, vomiting and retching
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eylül Tülay Aykul, master
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahcesehir university
City
Istanbul
State/Province
Besiktas
ZIP/Postal Code
34349
Country
Turkey

12. IPD Sharing Statement

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

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