Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 9, 2017
August 1, 2017
2.1 years
May 24, 2016
August 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Wexner constipation score
6 days
Patient Assessment of Constipation-Symptoms (PAC-SYM) score
6 days
Patient Assessment of Constipation Quality of Life (PAC-QOL) score
6 days
adverse events and safety
6 days
Study Arms (2)
Exposure Group
EXPERIMENTALParticipants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.
Control Group
PLACEBO COMPARATORParticipants were allocated to receive enemas twice daily for 6 consecutive days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Rome III criteria for chronic constipation present for ≥8 weeks.
You may not qualify if:
- Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy.
- Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies).
- Patients with medical or psychiatric illness.
- Patients with abnormal laboratory data or thyroid function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ning Li, MD
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 24, 2016
First Posted
May 26, 2016
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
August 9, 2017
Record last verified: 2017-08