Abdominoplasty SurgeryNCT06648694
Correlation Between Intra-abdominal Pressure and Diaphragmatic Mobility in Women Submitted to Abdominoplasty After Bariatric Surgery
An observational study of Abdominoplasty Surgery, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty Surgery
- What is being tested?
- Abdominoplasty surgery and Abdominoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2019to 10 Jan 2020
- Phase
- Observational
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing abdominal dermolipectomy surgery after gastroplasty who meet the eligibility criteria for the search.
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, 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Abdominoplasty Surgery
- Being tested
- Abdominoplasty surgery, Abdominoplasty
- Keywords
- Abdominoplasty, Abdominal Dermolipectomy, Bariatric Surgery, Obesity, Diaphragmatic Mobility, Intra-abdominal Pressure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominoplasty surgeryProcedure or surgery
Correlation between IAP and Diaphragmatic Mobility
AbdominoplastyProcedure or surgery
For the practice of the surgical procedure, the region to be operated on was marked using a surgical marking pen (Textel®). With the patient in the orthostatic position, a median line was drawn from the xiphoid appendix to the pubic symphysis, reaching the anterior vulvar commissure. Then, with the patient in the dorsal position, a transverse line was drawn 6 cm above the vulvar commissure and elongated to the iliac spine on each side. From there, the lateral skin surplus was estimated by means of bidigital clamping. The excess tissue was marked in a triangular shape, with a slight arching up to the xiphoid appendix. To determine the horizontal skin surplus, marking was performed, similar to that performed in classic abdominoplasty described in the literature(AMORIM FILHO; AMORIM, 2012). In this study, an anchor incision was recommended for all volunteers. All patients underwent intravenous sedation followed by spinal anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Mobility
Measure diaphragmatic mobility for total lung capacity maneuver
Measured: preoperative and on the 1st postoperative day.
Intraabdominal Pressure
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start2 Aug 2019
- Primary completion19 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominoplasty SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Fluhr Souto Barros, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648694
- Sponsor's protocol ID
- UFPernambucoCirDoutorado
- Status last verified
- Oct 2024
- First submitted
- 17 Dec 2023
- Last updated
- 18 Oct 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intra-abdominal Pressure and Diaphragmatic Mobility in Women Submitted to Abdominoplasty After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06648694
- Acronym / sponsor ID
- UFPernambucoCirDoutorado
- Conditions
- Abdominoplasty Surgery
- Keywords
- Abdominoplasty, Abdominal Dermolipectomy, Bariatric Surgery, Obesity, Diaphragmatic Mobility, Intra-abdominal Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 18 Oct 2024 (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.
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.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing abdominal dermolipectomy surgery after gastroplasty who meet the eligibility criteria for the search.
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 |
|---|---|---|
| Abdominoplasty surgeryCorrelation between IAP and Diaphragmatic Mobility | Procedure or surgery | – |
| AbdominoplastyFor the practice of the surgical procedure, the region to be operated on was marked using a surgical marking pen (Textel®). With the patient in the orthostatic position, a median line was drawn from the xiphoid appendix to the pubic symphysis, reaching the anterior vulvar commissure. Then, with the patient in the dorsal position, a transverse line was drawn 6 cm above the vulvar commissure and elongated to the iliac spine on each side. From there, the lateral skin surplus was estimated by means of bidigital clamping. The excess tissue was marked in a triangular shape, with a slight arching up to the xiphoid appendix. To determine the horizontal skin surplus, marking was performed, similar to that performed in classic abdominoplasty described in the literature(AMORIM FILHO; AMORIM, 2012). In this study, an anchor incision was recommended for all volunteers. All patients underwent intravenous sedation followed by spinal anesthesia. | Procedure or surgery | – |
Primary outcome
Diaphragmatic Mobility
Time frame: preoperative and on the 1st postoperative day.
Measure diaphragmatic mobility for total lung capacity maneuver
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.
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 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Abdominoplasty Surgery
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Not yet recruiting
Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair
Ventral Hernia, Incisional Hernia
Enrolling by invitation
Patient Satisfaction and Reflection on Drain Placement
Abdominoplasty, Panniculectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominoplasty Surgery, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Oct 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 Brazil. 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?
Diaphragmatic Mobility (time frame: preoperative and on the 1st postoperative day.). The study lists 2 primary outcomes in all. 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 18 Oct 2024.