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

Therapuetic Areas:Gastroenterology
Age Range:18 - Any
Start Date:August 2015
End Date:August 2018
Contact:Kevin M Schuster, MD, MPH

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A prospective randomized trial comparing non-operative management of small bowel obstruction
due to adhesions with or without a naso-gastric tube (NGT).

The study will be conducted in a prospective randomized design using the patient population
admitted to any of the general surgery services at Yale New Haven Hospital and presenting
with the presumed diagnosis of adhesive small bowel obstruction (SBO) to Yale New Haven
Hospital. All patients will be at least 30 days from any prior abdominal operative
procedure. Diagnosis of SBO will be by CT scan of the abdomen thereby excluding patients
with obstruction due to incarcerated hernias and minimizing the possibility the obstruction
is due to malignancy, volvulus or other cause. All patients selected for non-operative
management by the attending physician will be eligible for randomization to either the
"Nasogastric Tube Decompression" or "No Decompression" groups. Eligible patients will be
within 6 hours of hospital admission and not have had a naso-gastric tube (NGT) placed.
Patients who have a NGT placed by emergency physicians prior to consultation to the
emergency general surgery will be excluded. Patients who require NGT placement prior to
being approached for enrollment or prior to randomization will, if agreeable, be enrolled in
a prospective observational group of patients that will have the same data elements

Study Procedures:


Once consent from the patient or his/her surrogate has been obtained, eligible patients will
be randomized to either the "Nasogastric Tube Decompression" or the "No Decompression"
group. Sequentially numbered opaque sealed envelopes will be maintained in the locked office
of the surgical critical care fellow in the surgical intensive care unit. The grouping
assignment within these envelopes will be generated from computerized random number tables.
Patients randomized to nasogastric decompression will have a NGT placed within one hour of

Patient Management:

If patients in the "No Decompression" group develop recurrent or intractable emesis
unresponsive to anti-emetic medication or are deemed unsafe to be trialed with anti-emetic
medication due to a change in mental status by the attending physician they will have an NGT
placed and they will be followed as a third group of patients that failed management without
NGT decompression. Recurrent and/or intractable emesis will be defined as two or more
episodes of emesis of at least 50cc within a twelve hour period or a single large volume
emesis of 300cc or more.

For these patients NGT placement will not be mandatory however if patients do develop this
volume of emesis NGT placement will be considered consistent with the protocol. Change in
mental status will be loosely defined as the deterioration of the Glasgow Coma Scale (GCS)
to less than 14, however this will remain at the discretion of the attending physician. For
patients that have failure of NGT placement they will be managed at the discretion of the
attending surgeon but analyzed using an intention to treat methodology.

All other standard care for patients with SBO including intravenous fluids, correction of
electrolytes and management of chronic medical problems will be at the discretion of the
attending surgeon. All patients will be monitored daily with clinical examination for the
development of complications (vomiting, worsening abdominal pain, abnormal vital signs,
leukocytosis, fevers). Patients' subjective comfort levels will also be assessed daily in
each group using a visual analog scale. Pain will be managed will be with IV morphine unless
an allergy is present or develops in which case an alternative narcotic will be used based
on the decision of the treating physician. Improvement will be followed by return of bowel
function, improving abdominal pain and resolution of symptoms. The time taken to resolution
of symptoms in each group will be followed, as well as the relative number of patients
improving and deteriorating. All care decisions beyond the initial NGT placement, choice of
anti-emetic and choice of analgesic will be at the discretion of the attending surgeon.
These decisions may include but are not limited to NGT placement and removal, laboratory
testing, imaging (Abdominal X-rays and/or CT scan), diet advancement, and need for operative

Should a patient chose to withdraw from the study at any point after randomization
management of the NGT will then also come within the purview of the attending physician.
This may include placement of a NGT if the patient had been randomized to the no NGT arm or
removal even if in the NGT was placed as part of the protocol.

Primary Outcomes:

1. Hospital length of stay

Secondary Outcomes

1. Pain level, as measured by the visual analog scale and documented by the treating
nurse. The maximum and mean score for each day will be recorded. Pain will also be
assessed by the amount of used.

2. Duration of NGT use in hours.

3. The number of abdominal and chest imaging tests prior to discharge or operation
whichever comes first.

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
We found this trial at
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Kevin M Schuster, MD
Phone: 203-785-2572
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
New Haven, CT
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