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

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ClinicalTrials.gov Identifier: NCT02784093
Recruitment Status : Unknown
Verified August 2017 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, 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.

Condition or disease Intervention/treatment Phase
Fecal Impaction Drug: Gastrografin Procedure: enemas Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

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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



Primary Outcome Measures :
  1. the proportion of patients having successful disimpaction [ Time Frame: 6 days ]
    Successful disimpaction was indicated by the passage of watery stools.

  2. the time when patients having successful disimpaction [ Time Frame: 6 days ]
    Successful disimpaction was indicated by the passage of watery stools.


Secondary Outcome Measures :
  1. Wexner constipation score [ Time Frame: 6 days ]
    Severity of constipation symptoms was evaluated according to Wexner constipation scale.

  2. Patient Assessment of Constipation-Symptoms (PAC-SYM) score [ Time Frame: 6 days ]
    Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.

  3. Patient Assessment of Constipation Quality of Life (PAC-QOL) score [ Time Frame: 6 days ]
    Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire.

  4. adverse events and safety [ Time Frame: 6 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784093


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Ning Li, MD Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
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Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02784093    
Other Study ID Numbers: Gastrografin-FI
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Chronic Constipation
Fecal impaction
Gastrografin
Randomized Controlled Trial
Additional relevant MeSH terms:
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Fecal Impaction
Constipation
Signs and Symptoms, Digestive
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases