Back to resultsUse of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
Primary Purpose
Fecal Impaction
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gastrografin
enemas
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Impaction focused on measuring Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exposure Group
Control Group
Arm Description
Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.
Participants were allocated to receive enemas twice daily for 6 consecutive days.
Outcomes
Primary Outcome Measures
the proportion of patients having successful disimpaction
Successful disimpaction was indicated by the passage of watery stools.
the time when patients having successful disimpaction
Successful disimpaction was indicated by the passage of watery stools.
Secondary Outcome Measures
Wexner constipation score
Severity of constipation symptoms was evaluated according to Wexner constipation scale.
Patient Assessment of Constipation-Symptoms (PAC-SYM) score
Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.
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.
adverse events and safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784093
Brief Title
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
Official Title
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Impaction
Keywords
Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure Group
Arm Type
Experimental
Arm Description
Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants were allocated to receive enemas twice daily for 6 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Gastrografin
Intervention Type
Procedure
Intervention Name(s)
enemas
Primary Outcome Measure Information:
Title
the proportion of patients having successful disimpaction
Description
Successful disimpaction was indicated by the passage of watery stools.
Time Frame
6 days
Title
the time when patients having successful disimpaction
Description
Successful disimpaction was indicated by the passage of watery stools.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Wexner constipation score
Description
Severity of constipation symptoms was evaluated according to Wexner constipation scale.
Time Frame
6 days
Title
Patient Assessment of Constipation-Symptoms (PAC-SYM) score
Description
Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.
Time Frame
6 days
Title
Patient Assessment of Constipation Quality of Life (PAC-QOL) score
Description
Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire.
Time Frame
6 days
Title
adverse events and safety
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Organizational Affiliation
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
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