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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

NCT02977286

Constipation

TERMINATED PHASE4

Gastrografin in Postoperative Ileus

NCT01648972

Prolonged Postoperative Ileus

COMPLETED PHASE2/PHASE3

The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

NCT02705378

Constipation Critical Illness

WITHDRAWN PHASE3

Defecation Patterns in Constipated Patients

NCT04903470

Constipation by Outlet Obstruction

RECRUITING NA

Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects

NCT02737059

Constipation Drug Induced

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fecal Impaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exposure Group

Participants were allocated to receive 100 mL of Gastrograﬁn orally once daily for 6 consecutive days.

Group Type EXPERIMENTAL

Gastrograﬁn

Intervention Type DRUG

Control Group

Participants were allocated to receive enemas twice daily for 6 consecutive days.

Group Type PLACEBO_COMPARATOR

enemas

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gastrograﬁn

Intervention Type DRUG

enemas

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No