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Megarectum in Adults (MEGA-ORIGINE)

13 maggio 2026 aggiornato da: University Hospital, Rouen

Megarectum in Adults: Congenital or Acquired Pathology?

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Rouen, Francia, 76031
        • Digestive Physiology Department

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

  • Patients with idiopathic Mega-Rectum (MI) treated in the Digestive Physiology Department between 2016 and 2026 for the performance of a rectal barostat to confirm the megarectum suspected by anorectal manometry.
  • Constipated patients recruited consecutively during consultations by physicians in the Digestive Physiology department, and whose anorectal manometry, performed as part of routine care, ruled out the diagnosis of megarectum

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum
Lasso di tempo: 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.
1 day
To determine if patients with Idiopathic MegaRectum (MI) have a history of more digestive symptoms in childhood than constipated patients without megarectum
Lasso di tempo: 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.
1 day

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum
Lasso di tempo: 1 day
Determination 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
1 day
Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum
Lasso di tempo: 1 day
Presence of psychosocial factors in childhood: psychosocial or school-related stress, anxiety and depressive disorders as revealed by clinical questioning
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The 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.
1 day
megarectum phenotyping
Lasso di tempo: 1 day

The aim is to phenotype the megarectum using Balloon evacuation test is to assess a patient's ability to evacuate stools, particularly in cases of constipation or suspected defecation disorder. This test is based on the concept of success or failure.

Success:

The patient manages to expel the balloon within a timeframe considered normal (often < 1 to 2 minutes, according to protocols).

This suggests that the recto-anal evacuation mechanism is generally functioning correctly.

Failure:

The patient is unable to expel the balloon or takes an abnormally long time.

This may indicate a defecation disorder, for example:

anorectal dyssynergia (poor muscle coordination), rectal hypocontractility, or a functional obstruction to evacuation.
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The aim is to phenotype the megarectum using rectal Barostat is to allow the measurement of rectal distension volumes to obtain the desired rectal pressure
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The aim is to phenotype the megarectum using rectal Barostat is to allow the measurement of rectal distension volumes to obtain the rectal compliance
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The aim is to phenotype the megarectum using rectal Barostat is to allow the measurement of rectal distension volumes to obtain the maximum tolerable volume;
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The aim is to phenotype the megarectum using imagery is to assess rectal size in diameter
1 day
megarectum phenotyping
Lasso di tempo: 1 day
The aim is to phenotype the megarectum using imagery is to assess colon size in diameter
1 day
Constipation Severity Score Evaluation
Lasso di tempo: 1 day

This 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.
1 day
Constipation Severity Score Evaluation
Lasso di tempo: 1 day

This assessment is carried out using the Francis scores. The Francis score (or IBS-SSS: Irritable Bowel Syndrome Severity Scoring System) is used to measure the severity of Irritable Bowel Syndrome.

It assesses:

intensity of abdominal pain; frequency of pain; bloating/distension; bowel movement irregularities; and impact on quality of life.

The total score ranges from 0 to 500:

< 75: no or very mild symptoms; 75-175: mild; 175-300: moderate; 300: severe.
1 day
fecal incontinence severity score
Lasso di tempo: 1 day

The 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
1 day
Quality of life score assessment
Lasso di tempo: 1 day

The 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.
1 day
Quality of life score assessment
Lasso di tempo: 1 day

The quality of life score will be assessed using the PAC-QOL questionnaire. The PAC-QOL (Patient Assessment of Constipation - Quality Of Life) is a specific questionnaire used to assess the impact of chronic constipation on quality of life.The questionnaire typically contains 28 questions divided into several areas: 1) physical discomfort; 2) psychosocial discomfort; 3) worries/concerns; 4) satisfaction. Each item is rated on a scale of 0 to 4.

A low score indicates a good quality of life; A high score indicates a significant impact of constipation.
1 day
Quality of life score assessment
Lasso di tempo: 1 day

The quality of life score will be assessed using the FIQL questionnaires. The FIQL (Fecal Incontinence Quality of Life Scale) is a questionnaire designed to assess the impact of fecal incontinence on quality of life. The FIQL measures the psychological, social, and emotional impact of fecal incontinence, going beyond simply the frequency of leakage.

It explores, in particular: social discomfort; anxiety; self-image; limitations in daily activities; emotional impact.

The FIQL comprises 29 questions divided into 4 domains:

1) Lifestyle; 2) Behavior; 3) Depression/Self-Perception; 4) Embarrassment. Each question is scored on a scale of 0 to 4. A high FIQL indicates a better quality of life. A low FIQL indicates a significant impact of incontinence.
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
Identify 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)
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
Identify the predictive factors of each of these profiles in terms of personal history during the clinical interview with the patient (severe constipation requiring surgical intervention (and type of intervention) 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).
1 day
Current symptoms
Lasso di tempo: 1 day
Identify current symptoms: encopresis, fecal incontinence, dyschezia, abdominal bloating, abdominal pain, number of bowel movements per week, stool consistency according to the Bristol Stool Scale
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
information search regarding the age of toilet training in childhood during the clinical interview with the patient.
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
information search regarding childhood digestive symptoms during the clinical interview with the patient.
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
information regarding stool frequency in childhood and stool consistency in childhood during the clinical interview with the patient.
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
research for information regarding the factors identified as triggers of constipation during the clinical interview with the patient.
1 day
Predictive factors for each of these profiles in terms of medical history
Lasso di tempo: 1 day
information search regarding possible pain during defecation during the clinical interview with the patient.
1 day

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Rouen

Investigatori

  • Direttore dello studio: Anne-Marie AL LEROI, Professor, University Rouen Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

2 giugno 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

13 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2026/0116/OB
  • 2026-A00636-45 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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