AzTrials
AzTrials

Diastasis Recti and Weakness of the Linea AlbaSemilunareNCT05162612

Anatomo-radiological Study on Semilunar Line as Risk Factor fo Diastasis Recti Abdominis

An observational study of Diastasis Recti and Weakness of the Linea Alba, run by Marta Cavalli at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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: identify the presence of possible risk factors for diastasis recti abdominis evaluate the insertion of the aponeurosis of the internal… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
abtominal CT
How many people
987 participants
Where
2 sitesItaly
Study dates
13 Sep 2021to 13 Sep 2023
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 18 to 100 years
  • All sexes
  • Adult, Older adult

Study population: Patients requiring a Ct abdominal scan, for any diagnostic indication

Who may be able to join

  • Patients who can undergo CT examination
  • Adult patients (men and women, minimum age 18) requiring an abdominal CT scan, for any diagnostic indication
  • Signed informed consent for partecipation to the study and for processing of sensitive data
  • Filled anamnestic questionnaire

Who cannot join

  • Patients with severe neurological / psychiatric conditions
  • Minor patients (age <18 years)
  • women with a recent pregnancy or birth (in the last year)
  • patients with recent abdominal surgery (within the last six months).

Trial locations and contacts

2 sites in 1 country.

Marta Cavalli, PhD, MD contact

0233127862

m.cavalli2@uninsubria.it

Italy2 sites, 2 recruiting
  • Istituto Clinico Sant'Ambrogio - Centro di Ricerca di Alta Specializzazione sulla Patologia della Parete Addominale e sulla Chirurgia Riparativa delle Ernie Addominali

    Milan, 20147

    Marta Cavalli, PhD, MD

    Giampiero Campanelli, Prof, M. D.

    Recruiting
  • Ospedale di Circolo e Fondazione Macchi di Varese

    Varese

    Giulio Carcano, Prof, MD

    Giulio Caracano, Prof, M.D.

    Not yet recruiting

Other trials in Italy

About this study

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:

  • identify the presence of possible risk factors for diastasis recti abdominis
  • evaluate the insertion of the aponeurosis of the internal oblique muscle in the semilunar line in abdominal CT in a large series of patients
  • investigate the prevalence of the presence of only the posterior insertion of the internal oblique aponeurosis
  • evaluate the correlation of the presence of only the posterior lamella with the diastasis recti abdominia and with the pathology of the abdominal wall (ventral and/or incisional hernia)
  • evaluate the correlation between diastasis and other anatomo-radiological findings, such as the thickness of the rectus muscles and the distance between the lateral edge of the rectus muscles with the medial edges of the lateral abdominal muscles (external oblique, internal oblique and transverse)
  • evaluate the variability of the results
Read the detailed description

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:

  • Age
  • Sex
  • BMI
  • Previous abdominal surgical procedures (type and date)
  • Diabetes affection
  • Number of pregnancies and multiple birth, date of delivery and type of delivery (vaginal or caesarean section)

CT evaluation

A researcher, trained by an expert radiologist, will evaluate the axial image of abdominal standard CT to identify and record:

  • the internal oblique aponeurosis insertion in both side: classical double (anterior and posterior) insertion or only posterior insertion
  • The inter-recti distance at three regions, including supraumbilical (4,5 cm above the umbilicus), periumbilical and subumbilical (4.5 cm below the umbilicus)
  • The thickness and width of both rectus muscles
  • The distance between lateral edge of the rectus muscle and the medial edge of the internal oblique muscle
  • The distance between lateral edge of the rectus muscle and the medial edge of the external oblique muscle
  • The distance between lateral edge of the rectus muscle and the medial edge of the transverse muscle
  • Presence of abdominal wall hernia, if any

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.

Being tested
abtominal CT
Keywords
diastasis recti abdominal, abdominal wall hernia, semilunar line, internal oblique muscle, external oblique muscle, transversal muscle
Medical subject headings
Diastasis Recti And Weakness Of The Linea Alba, Hernia, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abtominal CTDiagnostic test

    standard basic Abdominal Ct scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (4)
  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start13 Sep 2021
  3. Primary completion8 Nov 2021
  4. Study completion13 Sep 2023 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
987 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162612
Sponsor's protocol ID
Semilunare
Acronym
Semilunare
Status last verified
Dec 2021
First submitted
16 Nov 2021
Last updated
17 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cavalli M, Aiolfi A, Bruni PG, Manfredini L, Lombardo F, Bonfanti MT, Bona D, Campanelli G. Prevalence and risk factors for diastasis recti abdominis: a review and proposal of a new anatomical variation. Hernia. 2021 Aug;25(4):883-890. doi: 10.1007/s10029-021-02468-8. Epub 2021 Aug 6.

    PubMed 34363190

Questions about this trial

What is this clinical trial studying?

An observational study of Diastasis Recti and Weakness of the Linea Alba, run by Marta Cavalli at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marta Cavalli, PhD, MD (0233127862, m.cavalli2@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of diastasis (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05162612, which also lists 1 linked publication.

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 17 Dec 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in