- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06648694
Correlation Between Intra-abdominal Pressure and Diaphragmatic Mobility in Women Submitted to Abdominoplasty After Bariatric Surgery
Background: Plication of the rectus abdominis muscles leads to an increase in intra-abdominal pressure (IAP), which may negatively impact the respiratory system due to its effects on diaphragmatic mobility (DM).
Objective: To establish the correlation between IAP following plication of the rectus abdominis muscles and DM in women who have undergone abdominoplasty after bariatric surgery.
Methods: This prospective cohort study evaluated DM and IAP using high-resolution ultrasound and intravesical pressure measurement during the preoperative, intraoperative, and 1st postoperative day (POD1) periods. Hypotheses: There is a negative correlation between intra-abdominal pressure values after plication of the rectus abdominis muscles and diaphragmatic mobility. There is an increase in intra-abdominal pressure after plication of the rectus abdominis muscles, which is aggravated by the modified Fowler position and the use of the compression belt. The greater the width of the diastasis, the greater the IAP.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
Plication of the rectus abdominis muscles leads to an increase in intra-abdominal pressure (IAP), which may negatively impact the respiratory system due to its effects on diaphragmatic mobility (DM).
Objective: To establish the correlation between IAP following plication of the rectus abdominis muscles and DM in women who have undergone abdominoplasty after bariatric surgery.
hypotheses:
The present study has the following hypotheses:
I. There is a negative correlation between intra-abdominal pressure values after plication of the rectus abdominis muscles and diaphragmatic mobility.
II. There is an increase in intra-abdominal pressure after plication of the rectus abdominis muscles.
III. The increase in intra-abdominal pressure is aggravated by the modified Fowler positioning.
IV. There is a positive correlation between diastasis width and intra-abdominal pressure.
V. Diaphragmatic mobility in the immediate postoperative period is reduced when compared to the preoperative period.
VI. The use of the compression belt increases intra-abdominal pressure. VII. There is a positive correlation between intra-abdominal pressure values and pain.
Objective: To establish the correlation between IAP following plication of the rectus abdominis muscles and DM in women who have undergone abdominoplasty after bariatric surgery.
Methods:
This is a prospective cohort study conducted in the surgical center of Hospital Agamenon Magalhães (HAM) in partnership with its plastic surgery outpatient clinic, from August 2017 to March 2020. The study evaluated intra-abdominal pressure in the preoperative period, immediately after plication of the rectus abdominis muscles in the supine position, post-plication of the rectus abdominis muscles in a modified Fowler's position, post-plication of the rectus abdominis muscles after complete abdominal suturing, post-abdominal bandaging, and on the 1st postoperative day (POD) with and without a compression garment, in healthy women undergoing abdominoplasty after gastroplasty.
This project was approved by the Research Ethics Committee of the Health Sciences Center at HC-UFPE (CAAE: 68563416.5.3001.5197). All participants included in this study met the eligibility criteria and signed the informed consent form.
The study included women aged 25 to 55 years old who underwent abdominoplasty after bariatric surgery under spinal anesthesia, with an anchor-shaped scar, presenting type IV or V abdominal deformity as described by Bozola [23], with stable body weight for a minimum of 6 months after achieving post-bariatric surgery weight loss goals, and a body mass index (BMI) ≤ 30 kg/m2. All study participants scored above 18 points on the Mini-Mental State Examination. Patients with respiratory and cardiac comorbidities and a history of smoking for more than 10 years were excluded from the analysis.
The primary outcomes analyzed were intra-abdominal pressure (IAP), expressed in millimeters of mercury (mmHg), and diaphragmatic mobility (DM), expressed in millimeters (mm). Secondary outcomes included the evaluation of dyspnea and pain levels.
Intra-abdominal pressure was measured during the preoperative period, immediately after plication of the rectus abdominis muscles with the abdomen open in the supine position and then in a modified Fowler's position, after abdominal wall synthesis, after bandaging, and on the 1st postoperative day with and without a compression garment. Diaphragmatic mobility, pain intensity, and dyspnea were evaluated in the preoperative period and on the 1st postoperative day.
Initially, anamnesis and physical examination were performed on all volunteers during the preoperative period, where personal data and anthropometric measurements were recorded: weight (Kg), height (m), and BMI; and vital signs: Respiratory Rate (RR) (rpm), Heart Rate (HR) (Bpm), Blood Pressure (BP) (mmHg), and Peripheral Oxygen Saturation (SPO2).
Since intravesical pressure measurement reflects intra-abdominal pressure, we measured it at the intraoperative periods mentioned earlier and on the 1st postoperative day. After obtaining bladder catheterization using a 16 Fr 3-way Foley catheter (Sisco®) with the outflow channel properly clamped, we connected the intermediate channel to a device composed of an intravenous infusion set (Hartmann®), which was attached to a calibrated stand with the zero mark positioned at the level of the patient's pubic symphysis.
This set was connected to a 0.9% sodium chloride solution bag for the injection of 50 ml of saline solution after bladder emptying at each measurement stage.
Thus, IAP was measured in cmH2O 30 seconds after saline infusion to obtain the pressure measurement after detrusor muscle relaxation of the bladder. This pressure was later converted to mmHg (1 cmH2O = 0.74 mmHg).
To assess diaphragmatic mobility, a high-resolution ultrasound device (Philips - HD11 XE) with a 3.5 MHz convex transducer was used, following the protocol described by Testa et al. The volunteers then received verbal instructions to perform forced vital capacity maneuvers, where the measurement of each curve, corresponding to the displacement of the diaphragmatic blade, was performed immediately after obtaining the images. The maneuvers were repeated until 5 satisfactory images were obtained. A mean of the 3 highest values was used, provided that these did not differ by more than 10% from each other. All DM measurements were performed by the same evaluator.
The Visual Analog Scale (VAS) was used to assess postoperative pain intensity. Patients were asked about their perception of dyspnea through the Modified Borg Scale, following the recommendations of the American Thoracic Society.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil
- Sandra Fluhr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic Mobility
Time Frame: preoperative and on the 1st postoperative day.
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Measure diaphragmatic mobility for total lung capacity maneuver
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preoperative and on the 1st postoperative day.
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|
Intraabdominal Pressure
Time Frame: preoperatively, after plication of the rectus abdominis muscles in the supine and modified Fowler positions, after abdominal wall synthesis, after bandaging and on the 1st postoperative day with and without girdle.
|
evaluated intra-abdominal pressure in the preoperative period, immediately after plication of the rectus abdominis muscles in the supine position, post-plication of the rectus abdominis muscles in a modified Fowler's position, post-plication of the rectus abdominis muscles after complete abdominal suturing, post-abdominal bandaging, and on the 1st postoperative day (POD) with and without a compression garment.
|
preoperatively, after plication of the rectus abdominis muscles in the supine and modified Fowler positions, after abdominal wall synthesis, after bandaging and on the 1st postoperative day with and without girdle.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UFPernambucoCirDoutorado
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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