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Starting soon Observational

Megarectum in Adults

NCT07599527 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06-01
Last updated
2026-05-20

Condition(s) studied

Idiopathic Megarectum

Investigational drug(s) / intervention(s)

Idiopathic megarectum groupConstipated patient group

Idiopathic megarectum group: questionnaires documented by patients with suspected megarectum on anorectal manometry and confirmed by rectal barostat

Constipated patient group: questionnaires completed by adult patients consulting for functional constipation without suspected megarectum on anorectal manometry

Study summary

Severe functional constipation associated with a pathological increase in rectal volume, with or without colonic dilation, is known as megarectum. In the absence of an organic cause, megarectum is called idiopathic. This condition can begin at birth, in childhood, or in adulthood. The exact incidence of idiopathic megarectum (IM) is unknown, but it is considered a rare condition. Clinically, IM is usually considered in the context of chronic constipation that is refractory to traditional treatments and accompanied by rectal distension, abdominal pain, encopresis, and recurrent fecal impaction. The pathophysiological basis of IM remains poorly understood. A study using a rectal barostat-a device that measures rectal capacity and compliance (the rectum's ability to distend) by controlled distension of a rectal balloon-identified two distinct subgroups of patients with MI: (1) those with increased rectal compliance, who can be described as having "physiological" megarectum, in which marked rectal hyposensitivity-characterized by the absence of perception of rectal distension-and hypocontractility lead to chronic fecal accumulation and progressive overdistension due to loss of rectal elasticity; and (2) those with normal rectal compliance, who can be considered to have anatomical megarectum. It is not yet known whether these subgroups reflect different underlying etiologies. Furthermore, in patients with physiological megarectum, it is unclear whether the condition is primary or secondary to long-term rectal distension.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Idiopathic megarectum (IM) group: * Adult patients presenting with chronic constipation according to the Rome criteria; * Patients with megarectum suspected by anorectal manometry and confirmed by rectal barostat; * Isolated, idiopathic megarectum (no known cause); Constipated group: * Constipated adult patients presenting consecutively with chronic functional constipation according to the Rome criteria; * Patients without megarectum suspected by anorectal manometry. Exclusion Criteria: * Patients who are not constipated; * Hirschsprung's disease; * Patients with anorectal malformation; * Patients with known neurological conditions; * Patients with endocrine disorders that may cause constipation; * Patients taking constipating medications such as morphine or neuroleptics; * Patients with a potential organic and/or drug-induced cause of constipation; * Constipation secondary to medication; * Patients unable to complete a questionnaire; * Patients deprived of their liberty, under guardianship, or curatorship

Primary outcome measure(s)

  • To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum — 1 day
    This involves comparing the history of constipation that may reveal anorectal dysfunction in childhood in constipated adults with MI and in constipated control subjects without megarectum through clinical questioning.
  • To determine if patients with Idiopathic MegaRectum (MI) have a history of more digestive symptoms in childhood than constipated patients without megarectum — 1 day
    This involves comparing the history of digestive symptoms that may reveal anorectal dysfunction in childhood in constipated adults with MI and in constipated control subjects without megarectum through clinical questioning.

Trial sites (1)

FacilityCityRegionStatus
Digestive Physiology Department Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07599527 on ClinicalTrials.gov ↗ ← All trials in France