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Status unknownNCT05162612SemilunareUpdated Dec 17, 2021

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

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

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
987
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diastasis Recti and Weakness of the Linea Alba

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Keywords

  • diastasis recti abdominal
  • abdominal wall hernia
  • semilunar line
  • internal oblique muscle
  • external oblique muscle
  • transversal muscle
03

In context

Diastasis, Muscle

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 →

Lead sponsor

This is the only study on the registry with Marta Cavalli as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients requiring a Ct abdominal scan, for any diagnostic indication

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
987 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testabtominal CT

    standard basic Abdominal Ct scan

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2 years

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 2 years

07

Study locations

1 of 2 sites 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, Italy
    • Marta Cavalli, PhD, MD · Contact
    • Giampiero Campanelli, Prof, M. D. · Principal investigator
    • Marta Cavalli, PhD, M. D. · Sub investigator
    • Piero Giovanni Bruni, PhD, M. D. · Sub investigator
    Recruiting
  • Ospedale di Circolo e Fondazione Macchi di Varese
    Varese, Italy
    • Giulio Carcano, Prof, MD · Contact
    • Giulio Caracano, Prof, M.D. · Principal investigator
    Not yet recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05162612
Lead sponsor
Marta Cavalli
Responsible party
Marta Cavalli (co-Investigator, researcher in General Surgery, University of Insubria, Surgeon in Istituto Clinico Sant'Ambrogio - Centro di Ricerca di Alta Specializzazione sulla Patologia della Parete Addominale e sulla Chirurgia Riparativa delle Ernie Addominali, Università degli Studi dell'Insubria) — Sponsor-investigator
First posted
Dec 17, 2021
Start date
Sep 13, 2021
Primary completion
Nov 8, 2021
Completion
Sep 13, 2023 (estimated)
Last update
Dec 17, 2021

Study contacts

Marta Cavalli, PhD, MD
Contact
m.cavalli2@uninsubria.it
0233127862

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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