Fecal Impaction
Conditions
Keywords
Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial
Brief summary
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.
Interventions
DRUGGastrografin
PROCEDUREenemas
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Rome III criteria for chronic constipation present for ≥8 weeks.
Exclusion criteria
1. Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy. 2. Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies). 3. Patients with medical or psychiatric illness. 4. Patients with abnormal laboratory data or thyroid function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients having successful disimpaction | 6 days | Successful disimpaction was indicated by the passage of watery stools. |
| the time when patients having successful disimpaction | 6 days | Successful disimpaction was indicated by the passage of watery stools. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wexner constipation score | 6 days | Severity of constipation symptoms was evaluated according to Wexner constipation scale. |
| Patient Assessment of Constipation-Symptoms (PAC-SYM) score | 6 days | Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire. |
| Patient Assessment of Constipation Quality of Life (PAC-QOL) score | 6 days | Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire. |
| adverse events and safety | 6 days | — |
Countries
China
Outcome results
None listed