Study Stopped
Study was closed due to lack of personnel for recruitment/enrollment purposes.
Prospective Study of Non-operative Management of SBO Without Nasogastric Tube Placement
NoNGT
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A prospective randomized trial comparing non-operative management of small bowel obstruction due to adhesions with or without a naso-gastric tube (NGT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 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
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2017
CompletedApril 7, 2017
April 1, 2017
1.7 years
August 17, 2015
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital length of stay
Total hospital length of stay.
30 days
Secondary Outcomes (3)
Pain measured on a visual analogue scale
30 days
Duration of nasogastric decompression
30 days
Number of radiographic studies ordered
30 days
Study Arms (2)
Placement of a Nasogastric tube
ACTIVE COMPARATORPlacement of a Nasogastric tube
No placement of a Nasogastric tube
EXPERIMENTALNo placement of a Nasogastric tube
Interventions
No placement of a Nasogastric tube
Eligibility Criteria
You may qualify if:
- All adult patients over 18 years of age who meet the following criteria will be recruited if identified:
- Admitted to a general surgery service with a presumptive diagnosis of adhesive SBO with or without a history of abdominal surgery. Have had no abdominal surgery in the 30 days prior to enrollment.
- Present from home or a long term care facility.
- CT scan of the abdomen performed within 36 hours of admission consistent with small bowel obstruction and without evidence the obstruction is due to an incarcerated hernia, malignancy or volvulus.
- Planned attempt at non-operative management by the attending surgeon.
- Have the capacity to provide informed consent for themselves.
You may not qualify if:
- Patient is deemed to need operative intervention at the time of presentation
- Pregnancy
- Contra-indication to NGT insertion
- Presence of a gastric feeding tube or dependent on tube feeding or parenteral nutrition on admission.
- Inability of the patient to protect their airway should emesis occur (as judged by the attending surgeon).
- Intractable emesis on admission.
- Abdominal surgery within 30 days prior to admission.
- Patients transferred from an inpatient status at another acute care hospital will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin M Schuster, MD, MPH
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 20, 2015
Study Start
August 1, 2015
Primary Completion
April 5, 2017
Study Completion
April 5, 2017
Last Updated
April 7, 2017
Record last verified: 2017-04