Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation

Study Overview
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Brief Summary
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Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. Gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. It has been shown to confer a therapeutic beneﬁt in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.

Official Title
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Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial

Conditions
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Fecal Impaction

Intervention / Treatment
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* Drug: Gastrograﬁn
* Procedure: enemas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment. Rome III criteria for chronic constipation present for ≥8 weeks. Exclusion Criteria: Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy. Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies). Patients with medical or psychiatric illness. Patients with abnormal laboratory data or thyroid function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure Group<br>Participants were allocated to receive 100 mL of Gastrograﬁn orally once daily for 6 consecutive days. | Drug: Gastrograﬁn<br> <br> |
| Placebo Comparator: Control Group<br>Participants were allocated to receive enemas twice daily for 6 consecutive days. | Procedure: enemas<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients having successful disimpaction | Successful disimpaction was indicated by the passage of watery stools. | 6 days | 
| the time when patients having successful disimpaction | Successful disimpaction was indicated by the passage of watery stools. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner constipation score | Severity of constipation symptoms was evaluated according to Wexner constipation scale. | 6 days | 
| Patient Assessment of Constipation-Symptoms (PAC-SYM) score | Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire. | 6 days | 
| Patient Assessment of Constipation Quality of Life (PAC-QOL) score | Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire. | 6 days | 
| adverse events and safety |  | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial