Clinical trial NCT05790317: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Presence and level of postoperative pain
timeFrame: 3 days
measure: Presence of post-operative nausea, vomiting and retching
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahcesehir university
state: Besiktas
Study officials:
affiliation: Bahçeşehir University
name: Eylül Tülay Aykul, master
role: PRINCIPAL_INVESTIGATOR
References: