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CompletedNCT05961345Updated Dec 12, 2024

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

An interventional study of late mobilization in Obesity, Morbid, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Cukurova University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Obesity, Morbid

Keywords

  • Obesity
  • Mobilization
  • Pain
  • Bariatric surgery
03

In context

Obesity, Morbid

936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.

This study's enrollment of 160 is above the median of 60 across 599 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Cukurova University is the lead sponsor of 257 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Can not speak Turkish
  • Refuse to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    early mobilization

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

    Other: late mobilization

  • No intervention
    control group (late mobilization)

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

Interventions

  • Otherlate mobilization

    Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.

    Also known as: Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 72 hours

07

Study locations

1 site
  • Adana City Training and Research Hospital
    Adana, Yüreğir 01220, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05961345
Responsible party
Cansel Bozer (Principal Investigator, Cukurova University) — Principal investigator
First posted
Jul 27, 2023
Start date
Aug 1, 2022
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Dec 12, 2024

Study contacts

Cansel Bozer
principal investigator · Cukurova University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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