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

NCT05162612 | Unknown

• 1 other identifier: Semilunare
• Study Type: observational
• Target: 987
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Diastasis Recti and Weakness of the Linea Alba

Keywords

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

Outcome Measures

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.

  2 years

Secondary Outcomes (4)

• insertion of the internal oblique apneurosis

  2 years

• correlation between diastasis and type of internal oblique insertion

  2 years

• correlation between abdominal wall hernia and type of internal oblique insertion

  2 years

• correlation between diastasi and other anatomo-radiolpgical findings

  2 years

Interventions

abtominal CT DIAGNOSTIC_TEST

standard basic Abdominal Ct scan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring a Ct abdominal scan, for any diagnostic indication

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Marta Cavalli: lead

Study Sites (2)

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

RECRUITING

Ospedale di Circolo e Fondazione Macchi di Varese

Varese, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 34363190 RESULT

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marta Cavalli, PhD, MD

CONTACT

0233127862; m.cavalli2@uninsubria.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 17, 2021
• Study Start: September 13, 2021
• Primary Completion: November 8, 2021
• Study Completion: September 13, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

IT (2)