Megarectum in Adults (MEGA-ORIGINE)
Megarectum in Adults: Congenital or Acquired Pathology?
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Vincent VF FERRANTI, ARC
- 電話番号：+33 02 32 88 82 65
- メール：Vincent.ferranti@chu-rouen.fr
研究連絡先のバックアップ
- 名前：Nabila NL LAAJAIL, Director
- 電話番号：+33 02 32 88 82 65
- メール：nabila.laajail@chu-rouen.fr
研究場所
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Rouen、フランス、76031
- Digestive Physiology Department
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
- 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
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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To determine if patients with Idiopathic MegaRectum (MI) have a history of earlier constipation in childhood than constipated patients without megarectum
時間枠：1 day
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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.
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1 day
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To determine if patients with Idiopathic MegaRectum (MI) have a history of more digestive symptoms in childhood than constipated patients without megarectum
時間枠：1 day
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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.
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1 day
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum
時間枠：1 day
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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
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1 day
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Comparison of environmental factors in constipated adults with MI and in constipated control subjects without megarectum
時間枠：1 day
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Presence of psychosocial factors in childhood: psychosocial or school-related stress, anxiety and depressive disorders as revealed by clinical questioning
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1 day
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megarectum phenotyping
時間枠：1 day
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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.
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1 day
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megarectum phenotyping
時間枠：1 day
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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
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megarectum phenotyping
時間枠：1 day
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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
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1 day
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megarectum phenotyping
時間枠：1 day
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The aim is to phenotype the megarectum using rectal Barostat is to allow the measurement of rectal distension volumes to obtain the rectal compliance
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1 day
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megarectum phenotyping
時間枠：1 day
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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;
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1 day
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megarectum phenotyping
時間枠：1 day
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The aim is to phenotype the megarectum using imagery is to assess rectal size in diameter
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1 day
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megarectum phenotyping
時間枠：1 day
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The aim is to phenotype the megarectum using imagery is to assess colon size in diameter
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1 day
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Constipation Severity Score Evaluation
時間枠：1 day
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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
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Constipation Severity Score Evaluation
時間枠：1 day
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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
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fecal incontinence severity score
時間枠：1 day
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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
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Quality of life score assessment
時間枠：1 day
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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
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Quality of life score assessment
時間枠：1 day
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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
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Quality of life score assessment
時間枠：1 day
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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
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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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)
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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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).
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1 day
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Current symptoms
時間枠：1 day
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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
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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information search regarding the age of toilet training in childhood during the clinical interview with the patient.
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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information search regarding childhood digestive symptoms during the clinical interview with the patient.
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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information regarding stool frequency in childhood and stool consistency in childhood during the clinical interview with the patient.
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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research for information regarding the factors identified as triggers of constipation during the clinical interview with the patient.
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1 day
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Predictive factors for each of these profiles in terms of medical history
時間枠：1 day
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information search regarding possible pain during defecation during the clinical interview with the patient.
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1 day
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協力者と研究者
捜査官
- スタディディレクター：Anne-Marie AL LEROI, Professor、University Rouen Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026/0116/OB
- 2026-A00636-45 (その他の識別子：ANSM)
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