An observational study in Diastasis Recti and Weakness of the Linea Alba, sponsored by Marta Cavalli. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Marta Cavalli · Observational
Multicenter cross-sectional observational study with the aim of investigating the prevalence of diastasis recti abdominis in adults and identifying its risk factors.
Secondary outcoms:
As usually described, at the lateral margin of the rectus sheath, the lateral muscles aponeurosis joins themselves in the semilunar line. The external oblique (EO) aponeurosis constantly passes in front of the rectus muscle (RM), composing the anterior lamina of the sheath. The internal oblique (IO) aponeurosis splits its fibers in an anterior and a posterior layer. The anterior layer joins the fibers of the EO in front of RM to constitute the anterior lamina. But some centimeters below the umbilicus, there is no split in the fibers, and all the aponeurosis of the IO join the EO and transverse aponeurosis in constituting the anterior sheath. The transverse muscle aponeurosis also behaves differently from cranial to caudal. Cranially the fibers constantly remain posterior to the RM and constitutes the deep layer of the sheath, but at a variable level some centimeters below the umbilicus, they go anteriorly will all other flat muscle aponeurosis.
During cadaveric dissections and in a careful evaluation of various CT abdominal wall images, we noted that the IO aponeurosis can join the rectus sheath in two ways: a) splitting its fibers in an anterior and posterior layer, as classically described, or b) joining only the posterior rectus sheath without an anterior layer.
To confirm our hypothesis, we design this multicenter cross-sectional observational study.
Data collection:
For each patient, together principal endpoints, following additional variables will be collected:
CT evaluation
A researcher, trained by an expert radiologist, will evaluate the axial image of abdominal standard CT to identify and record:
Definition and classification of DRA According Rath et al. (13) proposal, for subjects younger than 45 years, DRA will be defined as a separation of the two recti more than 1.0 cm above the umbilicus, 2.7 cm at the periumbilicus and 0.9 cm below the umbilicus; for subjects over 45 years, the corresponding values will be 1.5 cm, 2.7 cm and 1.4 cm, respectively. The presence of an inter-recti distance superior to the cut off value in two or three regions (supraumbilical, umbilical and subumbilical) in the same patient will be described as DRA.
Width of the DRA will be defined according Ranney (15) classification: an IRD \< 3 cm will be labeled mild diastasis, 3-5 cm IRD moderate diastasis and more than 5 cm severe diastasis.
41 studies on the registry are indexed under Diastasis, Muscle; 9 are open to participants now.
This study's planned enrollment of 987 is above the median of 53 across 10 observational studies indexed under Diastasis, Muscle.
Browse Diastasis, Muscle studies →This is the only study on the registry with Marta Cavalli as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients requiring a Ct abdominal scan, for any diagnostic indication
Exclusion Criteria:
standard basic Abdominal Ct scan
Prevalence of diastasis
Number of patients presenting diastasis. According Rath et al. proposal, for subjects younger than 45 years, diastasis will be defined as a separation of the two recti more than 1.0 cm at 45mm above the umbilicus, 2.7 cm at the periumbilicus and 0.9 cm at 45 mm below the umbilicus; for subjects over 45 years, the corresponding values will be 1.5 cm, 2.7 cm and 1.4 cm, respectively.
Time frame: 2 years
insertion of the internal oblique apneurosis
Accordin our hypothesis the internal oblique aponeurosis can join the rectus sheath in two way: a) splitting its fibers in an anterior and posterior layer, as classically described, or b) joining only the posterior rectus sheath without an anterior layer. We will evaluted how many patient presentig a double insertion (anterior and posterior) and how many a single posterior insertion
Time frame: 2 years
correlation between diastasis and type of internal oblique insertion
number of patient with single posterior insertion presenting diastasis and number of patient with classic double insertion presentig diastasis
Time frame: 2 years
correlation between abdominal wall hernia and type of internal oblique insertion
number of patient with single posterior insertion presenting hernia and number of patient with classic double insertion presentig hernia
Time frame: 2 years
correlation between diastasi and other anatomo-radiolpgical findings
the following measures will be taken: * tickness of both rectus muscle (mm) * width of both rectus muscle (mm) * distance (mm) between the laterl edge of retus muscle and the medial edge of external oblique muscle, internal oblique muscle and trasnversus muscle
Time frame: 2 years
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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