Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05961345 |
| Other study ID # |
CU-SBF-CB-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. A
study is planned to determine postoperative early mobilization, postoperative pain and
hospital stay in patients hospitalized in Bariatric Surgery post-operative clinics.
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.
