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

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

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.

Study Overview

• Status: Unknown
• Conditions: Fecal Impaction
• Intervention / Treatment: Drug: Gastrografin; Procedure: enemas

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Director: Ning Li, MD, Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Constipation; Randomized Controlled Trial; Fecal impaction; Gastrografin
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Constipation; Fecal Impaction
• Other Study ID Numbers: Gastrografin-FI