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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded 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 is used as a radiologic contrast agent and may be administered orally or rectally. It has been shown to confer a therapeutic benefit in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin given enterally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.

Detailed Summary:
Sponsor: Jinling Hospital, China

Current Primary Outcome:

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


Original Primary Outcome: the proportion of patients having successful disimpaction within 7 days [ Time Frame: 7 days ]

Successful disimpaction was indicated by the passage of watery stools.


Current Secondary Outcome:

  • Wexner constipation score [ Time Frame: 6 days ]
    Severity of constipation symptoms was evaluated according to Wexner constipation scale.
  • Patient Assessment of Constipation-Symptoms (PAC-SYM) score [ Time Frame: 6 days ]
    Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.
  • 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.
  • adverse events and safety [ Time Frame: 6 days ]


Original Secondary Outcome:

  • defecation frequency per day [ Time Frame: 7 days ]
  • the proportion of patients having fecal incontinence [ Time Frame: 7 days ]
  • the proportion of patients having abdominal pain [ Time Frame: 7 days ]
  • the proportion of patients having perseverative watery stools [ Time Frame: 7 days ]
  • behavior scores per day [ Time Frame: 7 days ]


Information By: Jinling Hospital, China

Dates:
Date Received: May 24, 2016
Date Started: April 2015
Date Completion: June 2017
Last Updated: April 7, 2017
Last Verified: April 2017