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

Phase 2

• Conditions: Fecal Impaction
• Interventions: Drug: Gastrografin; Procedure: enemas

• Registration Number: NCT02784093
• Lead Sponsor: Jinling Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Primary Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure Group	Gastrografin	Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.
Control Group	enemas	Participants were allocated to receive enemas twice daily for 6 consecutive days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China