Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Megarectum in Adults (MEGA-ORIGINE)

13. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Frankreich
      • Rouen, Frankreich, 76031
        • Digestive Physiology Department

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

  • 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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Rouen

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

2. Juni 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2026/0116/OB
  • 2026-A00636-45 (Andere Kennung: ANSM)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren