NCT06648694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

December 17, 2023

Last Update Submit

October 16, 2024

Conditions

Keywords

AbdominoplastyAbdominal DermolipectomyBariatric SurgeryObesityDiaphragmatic MobilityIntra-abdominal Pressure

Outcome Measures

Primary Outcomes (2)

  • Diaphragmatic Mobility

    Measure diaphragmatic mobility for total lung capacity maneuver

    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.

    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.

Interventions

Correlation between IAP and Diaphragmatic Mobility

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.

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sandra Fluhr

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 17, 2023

First Posted

October 18, 2024

Study Start

August 2, 2019

Primary Completion

December 19, 2019

Study Completion

January 10, 2020

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations