Obesity, MorbidNCT05961345
The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery
A study testing late mobilization in people with Obesity, Morbid, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- late mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Can not speak Turkish
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, Yüreğir, 01220
About this study
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- late mobilization
- Keywords
- Obesity, Mobilization, Pain, Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
late mobilizationOther
Also called Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.
Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.
| Study group | Role | What they receive |
|---|---|---|
| early mobilization | Experimental | The patients in the experimental group were mobilized at the 4th postoperative hour. Receives: Other: late mobilization |
| control group (late mobilization) | No intervention | The patients in the control group were mobilized at the 6th hour as in the routine of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, a control and an experimental group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansel Bozer, Cukurova University
- Investigators
- Cansel Bozer, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961345
- Sponsor's protocol ID
- CU-SBF-CB-01
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Mobilization on Pain Level After Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05961345
- Acronym / sponsor ID
- CU-SBF-CB-01
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, Mobilization, Pain, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups, a control and an experimental group.
| Arm | Type | Receives |
|---|---|---|
| early mobilization | Experimental | Other: late mobilizationThe patients in the experimental group were mobilized at the 4th postoperative hour. |
| control group (late mobilization) | No intervention | –The patients in the control group were mobilized at the 6th hour as in the routine of the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Can not speak Turkish
- Refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| late mobilizationAlso: Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people. | Other | early mobilization |
Primary outcome
The Numerical Pain Rating Acale (NRS)
Time frame: 72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity, Morbid
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cansel Bozer principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing late mobilization in people with Obesity, Morbid, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Pain Rating Acale (NRS) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.