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.
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
- Conditions the study is for
- Diastasis Recti and Weakness of the Linea Alba
- 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.
Italy2 sites, 2 recruiting
- 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.
- Not yet recruiting
Ospedale di Circolo e Fondazione Macchi di Varese
Varese
Giulio Carcano, Prof, MD
Giulio Caracano, Prof, M.D.
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.
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)
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
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
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
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.
- First posted17 Dec 2021
- Study start13 Sep 2021
- Primary completion8 Nov 2021
- Study completion13 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti and Weakness of the Linea AlbaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marta Cavalli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Cavalli, Università degli Studi dell'Insubria
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomo-radiological Study on Semilunar Line as Risk Factor fo Diastasis Recti Abdominis
- ClinicalTrials.gov ID
- NCT05162612
- Acronym / sponsor ID
- Semilunare / Semilunare
- Keywords
- diastasis recti abdominal, abdominal wall hernia, semilunar line, internal oblique muscle, external oblique muscle, transversal muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 987 participants (estimated)
- Lead sponsor
- Marta CavalliUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 13 Sep 2023 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a Ct abdominal scan, for any diagnostic indication
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abtominal CTstandard basic Abdominal Ct scan | Diagnostic test | – |
Primary outcome
Prevalence of diastasis
Time frame: 2 years
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.
4 secondary outcomes
insertion of the internal oblique apneurosis
Time frame: 2 years
correlation between diastasis and type of internal oblique insertion
Time frame: 2 years
correlation between abdominal wall hernia and type of internal oblique insertion
Time frame: 2 years
correlation between diastasi and other anatomo-radiolpgical findings
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Results publication: PubMed 34363190Cavalli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
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.