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The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery

Primary Purpose

Obesity, Morbid

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
experimental group
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Obesity, Mobilization, Pain, Bariatric surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 18 years old Can speak Turkish Agreeing to participate in the study No postoperative complications Patients with American Society of Anesthesiology (ASA) evaluation I, II, III were included in the sample group Exclusion Criteria: Can not speak Turkish Refuse to participate in the study

Sites / Locations

  • Adana City Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

early mobilization (experimental group)

control group (late mobilization)

Arm Description

The patients in the experimental group were mobilized at the 4th postoperative hour.

The patients in the control group were mobilized at the 6th hour as in the routine of the clinic.

Outcomes

Primary Outcome Measures

The Numerical Pain Rating Acale (NRS)
Numerical pain rating scale is a scale that evaluates the severity of pain from 0 to 10.As the severity of pain increases, the number value increases. A number value of 0 means no pain, while 10 is the most severe pain.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05961345
Brief Title
The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery
Official Title
The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova 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
According to the definition of the WHO, obesity is the abnormal or excessive accumulation of fat in the body. Laparoscopic operations; It is a popular choice for bariatric surgery. A study is planned to determine postoperative early mobilization, postoperative pain and hospital stay in patients hospitalized in Bariatric Surgery post-operative clinics.
Detailed Description
According to the definition of the World Health Organization (WHO), obesity is the abnormal or excessive accumulation of fat in the body to the extent that it adversely affects health. Obesity; It is a chronic disease associated with multiple pathologies such as diabetes mellitus, cardiovascular diseases and different types of cancer, affecting the individual physically and psychosocially, which may occur due to social-economic level, lifestyle, cultural factors, and the decrease in energy consumption due to the slowing of the metabolic rate due to aging. Obesity is one of the serious and high prevalence health problems of the 21st century. When WHO data is examined; There are 1.9 billion overweight people and 650 million obese individuals in the world. When Turkey's data is analyzed, it ranks first in Europe with a 32 percent obesity rate. Since obesity is preventable and treatable, many treatment protocols are available. In the treatment of obesity, it is planned to increase physical activities in addition to changing nutritional habits as the primary method. Subsequently, behavioral and medical treatment are among the preferred methods. If the desired result cannot be obtained, invasive or minimally invasive techniques are used in the treatment of this patient group with a body mass index (BMI) ≥ 40 kg/m2 or a BMI range of 35-39.9 kg/m2 and in addition to obesity-related metabolic diseases. bariatric surgery is considered. Laparoscopic operations; It is a popular choice for bariatric surgery because of its ease of procedure, with proven long-term results in improving weight loss and obesity-related comorbidities. With the inclusion of the laparoscopic approach in surgical procedures, minimally invasive laparoscopic bariatric surgeries have become widespread in the field of bariatric surgery. Bariatric operations are associated with their unique short-term and long-term nutritional and procedural complications. Enhanced Recovery After Surgery (ERAS), is patient recovery protocols (eras) that aim to minimize postoperative complications in patients and plan discharge in a short time. The basic principle of ERAS protocols; Reducing the pain associated with the stress and postoperative complications secondary to surgery, and ensuring the well-being of the patient by providing early mobilization in the postoperative period. After laparoscopic bariatric surgery, shoulder pain due to increased intra-abdominal pressure, stretching of the peritoneum, inability to take air given carbon dioxide (CO2), diaphragm irritation due to tension of muscle fibers, and visceral pain due to the interference of trocars on the abdominal wall after intra-abdominal intervention are observed.Unwillingness to mobilize and insufficient respiratory function can be seen in patients due to abdominal and shoulder pain.Muscle atrophy develops with the increase in insulin resistance in patients due to the prolonged postoperative immobilization time. In addition, the risk of thromboembolism should be considered. It is planned to return the gastrointestinal functions of the patients after the surgery, to perform early muscle activities, to provide early venous conversion, to minimize the risks such as embolism, and early mobilization of the patients is supported. Although early mobilization causes these positive results, there is no study in the literature with the effectiveness of mobilization for postoperative pain. In addition, it is not known where the pain scales of the patients become stable in terms of postoperative discharge times. Therefore, our study has two main endpoints. It is planned that the study will guide the literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Obesity, Mobilization, Pain, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups, a control and an experimental group.
Masking
ParticipantOutcomes Assessor
Masking Description
the experimental group was conducted early by the researcher and the outcome evaluations were performed by the researcher who blinded the group allocation
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early mobilization (experimental group)
Arm Type
Experimental
Arm Description
The patients in the experimental group were mobilized at the 4th postoperative hour.
Arm Title
control group (late mobilization)
Arm Type
No Intervention
Arm Description
The patients in the control group were mobilized at the 6th hour as in the routine of the clinic.
Intervention Type
Other
Intervention Name(s)
experimental group
Other Intervention Name(s)
Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.
Intervention Description
Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.
Primary Outcome Measure Information:
Title
The Numerical Pain Rating Acale (NRS)
Description
Numerical pain rating scale is a scale that evaluates the severity of pain from 0 to 10.As the severity of pain increases, the number value increases. A number value of 0 means no pain, while 10 is the most severe pain.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years old Can speak Turkish Agreeing to participate in the study No postoperative complications Patients with American Society of Anesthesiology (ASA) evaluation I, II, III were included in the sample group Exclusion Criteria: Can not speak Turkish Refuse to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cansel Bozer
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adana City Training and Research Hospital
City
Adana
State/Province
Yüreğir
ZIP/Postal Code
01220
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery

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