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

Fecal Impaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02784093
• Other study ID #: Gastrografin-FI
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 24, 2016
• Last updated: August 8, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Fecal Impaction

Intervention

Drug:
• Gastrogra?n

Procedure:
• enemas

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients having successful disimpaction	Successful disimpaction was indicated by the passage of watery stools.	6 days
Primary	the time when patients having successful disimpaction	Successful disimpaction was indicated by the passage of watery stools.	6 days
Secondary	Wexner constipation score	Severity of constipation symptoms was evaluated according to Wexner constipation scale.	6 days
Secondary	Patient Assessment of Constipation-Symptoms (PAC-SYM) score	Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.	6 days
Secondary	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
Secondary	adverse events and safety		6 days