NCT06648694|Completed
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Sponsor study identifier
observational
12
1 country
1
Study Start
August 2, 2019
Actual (reported)Primary Completion
December 19, 2019
Actual (reported)Study Completion
January 10, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2019
Actual (reported)December 19, 2019
Actual (reported)January 10, 2020
Actual (reported)December 17, 2023
Actual (reported)October 18, 2024
Actual (reported)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.
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.
Women undergoing abdominal dermolipectomy surgery after gastroplasty who meet the eligibility criteria for the search.
Sandra Fluhr
Recife, Pernambuco, Brazil
12 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2023
First Posted
October 18, 2024
Study Start
August 2, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 19, 2019
Actual (reported)Study Completion
January 10, 2020
Actual (reported)Last Updated
October 18, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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