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

Sponsor

Jinling Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02784093

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Impaction	Drug: Gastrograﬁn Procedure: enemas	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exposure Group Participants were allocated to receive 100 mL of Gastrograﬁn orally once daily for 6 consecutive days.	Drug: Gastrograﬁn
Placebo Comparator: Control Group Participants were allocated to receive enemas twice daily for 6 consecutive days.	Procedure: enemas

Arm

Intervention/Treatment

Experimental: Exposure Group

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

Drug: Gastrograﬁn

Placebo Comparator: Control Group

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

Procedure: enemas

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Wexner constipation score [6 days]
Severity of constipation symptoms was evaluated according to Wexner constipation scale.
Patient Assessment of Constipation-Symptoms (PAC-SYM) score [6 days]
Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.
Patient Assessment of Constipation Quality of Life (PAC-QOL) score [6 days]
Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire.
adverse events and safety [6 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.