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Megarectum in Adults (MEGA-ORIGINE)

13. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

120

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Francie
      • Rouen, Francie, 76031
        • Digestive Physiology Department

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

  • 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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 1 day
The aim is to phenotype the megarectum using imagery is to assess rectal size in diameter
1 day
megarectum phenotyping
Časové okno: 1 day
The aim is to phenotype the megarectum using imagery is to assess colon size in diameter
1 day
Constipation Severity Score Evaluation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 1 day
information search regarding possible pain during defecation during the clinical interview with the patient.
1 day

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Rouen

Vyšetřovatelé

  • Ředitel studie: Anne-Marie AL LEROI, Professor, University Rouen Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

2. června 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2026/0116/OB
  • 2026-A00636-45 (Jiný identifikátor: ANSM)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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