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Megarectum in Adults

Megarectum in Adults: Congenital or Acquired Pathology?

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07599527
Acronym
MEGA-ORIGINE
Enrollment
120
Registered
2026-05-20
Start date
2026-06-01
Completion date
2028-12-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Megarectum

Keywords

severe functional constipation, understanding pathophysiology.

Brief 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.

Detailed description

The aim of this study is to identify and characterize elements of the clinical history, particularly early ones, associated with the disease, in order to contribute to the understanding of its pathophysiology. To this end, the project aims to analyze the personal and family histories of patients with idiopathic bowel dysfunction (BD) and compare them with a population of constipated patients without BD, in order to determine the chronology of the onset of the condition (from birth, childhood/adolescence, or later) and to evaluate the risk factors for BD. It is also planned to describe the population of patients with BD to confirm whether or not different subgroups exist. A better understanding of the pathophysiology of BD should make it possible to prevent the condition (if secondary to dyssynergia present in childhood) and/or to provide earlier, more appropriate management, thus avoiding acute episodes of bowel obstruction.

Interventions

OTHERIdiopathic megarectum group

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

OTHERConstipated patient group

questionnaires completed by adult patients consulting for functional constipation without suspected megarectum on anorectal manometry

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum1 dayThis 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 megarectum1 dayThis 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.

Secondary

MeasureTime frameDescription
Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum1 dayDetermination of the presence of environmental factors in childhood: breastfeeding, repeated early antibiotic therapy, drug treatment in childhood and indication (antibiotics, anticholinergic treatments, opiates, morphine, etc.) through clinical questioning
megarectum phenotyping1 dayThe aim is to phenotype the megarectum using anorectal manometry to distinguish an "acquired" profile from a "congenital" profile. The measured indicators will be anal tone, amplitude and duration of voluntary contraction, the presence of the rectoanal inhibitory reflex; the amplitude of the rectoanal inhibitory reflex at 30 ml of rectal distension; the presence of rectosphincter dyssynergia; the amplitude of rectal contraction during straining; the percentage of anal relaxation during straining; the residual pressure during straining; the threshold volume for perceiving rectal distension; the constant perceiving volume; the maximum tolerable volume; and rectal compliance.
Constipation Severity Score Evaluation1 dayThis assessment is carried out using the Kess scores. The KESS score (KESS score = Knowles-Eccersley-Scott Symptom score) is intended to assess the severity of chronic constipation. It takes into account: frequency of bowel movements; difficulty passing stool; feeling of incomplete evacuation; use of laxatives; pain or straining; duration of the problem. The higher the score, the more severe the constipation.
fecal incontinence severity score1 dayThe Cleveland Clinic score will be used to assess the severity of chronic constipation. This score assesses several factors: frequency of bowel movements; difficulty of defecation; straining; feeling of incomplete evacuation; abdominal pain; time spent on the toilet; need for assistance (laxatives, enemas, digital defecation); duration of constipation. Each item is assigned a number of points. In practice: \< 8: mild constipation; 8-15: moderate constipation; \> 5: severe constipation
Quality of life score assessment1 dayThe quality of life score will be assessed using the GIQLI questionnaires. The GIQLI (Gastrointestinal Quality of Life Index) is a questionnaire used to measure quality of life related to digestive diseases. The questionnaire comprises 36 questions. Each question is scored from 0 to 4 on the following scale: 0 = very poor condition / significant symptoms 4 = no problems The maximum score is 144. A high score indicates good digestive health. A low score indicates significant impact of digestive disease.
Predictive factors for each of these profiles in terms of medical history1 dayIdentify predictive factors for each of these profiles in terms of family history during the clinical interview with the patient (severe constipation leading to surgery (and type of surgery) or difficult to treat medically, onset of constipation in childhood or adulthood, Hirschsprung's disease, colonic inertia, chronic intestinal pseudo-obstruction, gastroparesis, stoma, gastrostomy, enteral or parenteral nutrition, anorectal malformation, neurological malformation)
Current symptoms1 dayIdentify current symptoms: encopresis, fecal incontinence, dyschezia, abdominal bloating, abdominal pain, number of bowel movements per week, stool consistency according to the Bristol Stool Scale

Countries

France

Contacts

CONTACTNabila NL LAAJAIL, Director
Nabila.Laajail@chu-rouen.fr02 32 88 82 65
CONTACTvincent VF FERRANTI, ARC
Vincent.Ferranti@chu-rouen.fr02 32 88 82 65
STUDY_DIRECTORAnne-Marie AL LEROI, Professor

University Rouen Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026