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Prospective Study of Non-operative Management of SBO Without Nasogastric Tube Placement (NoNGT)

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ClinicalTrials.gov Identifier: NCT02530086
Recruitment Status : Withdrawn (Study was closed due to lack of personnel for recruitment/enrollment purposes.)
First Posted : August 20, 2015
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Small Bowel Obstruction Procedure: Nasogastric tube placement Procedure: No Nasogastric tube use

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Non-operative Management of SBO Without Nasogastric Tube Placement
Study Start Date : August 2015
Primary Completion Date : April 5, 2017
Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Placement of a Nasogastric tube
Placement of a Nasogastric tube
Procedure: Nasogastric tube placement
Placement of a Nasogastric tube
Experimental: No placement of a Nasogastric tube
No placement of a Nasogastric tube
Procedure: No Nasogastric tube use
No placement of a Nasogastric tube


Outcome Measures

Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 30 days ]
    Total hospital length of stay.


Secondary Outcome Measures :
  1. Pain measured on a visual analogue scale [ Time Frame: 30 days ]
    Pain will be measured daily using a visual analog scale and milligrams of morphine used.

  2. Duration of nasogastric decompression [ Time Frame: 30 days ]
  3. Number of radiographic studies ordered [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530086


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kevin M Schuster, MD, MPH Yale School of Medicine
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02530086     History of Changes
Other Study ID Numbers: 1504015652
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases