Prospective Study of Non-operative Management of SBO Without Nasogastric Tube Placement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Hospital length of stay
研究概览
简要总结
A prospective randomized trial comparing non-operative management of small bowel obstruction due to adhesions with or without a naso-gastric tube (NGT).
详细描述
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 collected.
Study Procedures:
Randomization:
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 randomization.
Patient Management:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hospital length of stay
时间窗: 30 days
Total hospital length of stay.
次要结局
- Duration of nasogastric decompression(30 days)
- Pain measured on a visual analogue scale(30 days)
- Number of radiographic studies ordered(30 days)