Fecal ImpactionPhase 2NCT02784093
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
A Phase 2 study testing Gastrografin and enemas in people with Fecal Impaction, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Impaction
- What is being tested?
- Gastrografin and enemas
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
About this study
Official title: 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.
- Conditions
- Fecal Impaction
- Being tested
- Gastrografin, enemas
- Keywords
- Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial
- Medical subject headings
- Fecal Impaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrografinDrug
enemasProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Exposure Group | Experimental | Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days. Receives: Drug: Gastrografin |
| Control Group | Placebo comparator | Participants were allocated to receive enemas twice daily for 6 consecutive days. Receives: Procedure: enemas |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients having successful disimpaction
Successful disimpaction was indicated by the passage of watery stools.
Measured: 6 days
the time when patients having successful disimpaction
Successful disimpaction was indicated by the passage of watery stools.
Measured: 6 days
Secondary outcomes (4)
Wexner constipation score
Severity of constipation symptoms was evaluated according to Wexner constipation scale.
Measured: 6 days
Patient Assessment of Constipation-Symptoms (PAC-SYM) score
Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.
Measured: 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.
Measured: 6 days
adverse events and safety
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal ImpactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Ning Li, MD, Study director, Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784093
- Sponsor's protocol ID
- Gastrografin-FI
- Status last verified
- Aug 2017
- First submitted
- 24 May 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02784093
- Acronym / sponsor ID
- Gastrografin-FI
- Conditions
- Fecal Impaction
- Keywords
- Chronic Constipation, Fecal impaction, Gastrografin, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group | Experimental | Drug: GastrografinParticipants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days. |
| Control Group | Placebo comparator | Procedure: enemasParticipants were allocated to receive enemas twice daily for 6 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrografin | Drug | Exposure Group |
| enemas | Procedure or surgery | Control Group |
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.
4 secondary outcomes
Wexner constipation score
Time frame: 6 days
Patient Assessment of Constipation-Symptoms (PAC-SYM) score
Time frame: 6 days
Patient Assessment of Constipation Quality of Life (PAC-QOL) score
Time frame: 6 days
adverse events and safety
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, MD study director
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gastrografin and enemas in people with Fecal Impaction, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients having successful disimpaction (time frame: 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.