Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648694
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-12-17
Brief Title:
Correlation Between Intra-abdominal Pressure and Diaphragmatic Mobility in Women Submitted to Abdominoplasty After Bariatric Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlation Between Intra-abdominal Pressure and Diaphragmatic Mobility in Women Submitted to Abdominoplasty After Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Fowlers 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 68563416530015197 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 kgm2 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 Fowlers 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 patients pubic symphysis
This set was connected to a 09 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 074 mmHg
To assess diaphragmatic mobility a high-resolution ultrasound device Philips - HD11 XE with a 35 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
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 Fowlers 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 68563416530015197 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 kgm2 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 Fowlers 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 patients pubic symphysis
This set was connected to a 09 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 074 mmHg
To assess diaphragmatic mobility a high-resolution ultrasound device Philips - HD11 XE with a 35 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None