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NCT Number: NCT05790317

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

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Key information

Conditions

Obesity, Morbid Ache Bariatric Surgery Candidate Body Weight DVT Diabetes Diabetes Mellitus ERAS Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nausea Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Adult Onset Obesity Associated Disorder Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Procedural Discharge Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahcesehir university

Istanbul, Besiktas, 34349, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Procedure with ERAS Protocol

Procedure

It covers the period before, during and after the surgery.

Other names: Fast Track Surgery

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

Comparıson Of The Effects Of The Eras Protocol Applıcatıon And The Effects Of The Tradıtıonal Method On The In Obesıty Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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