Evaluating the use of nasogastric tubes in treating small bowel obstruction due to adhesions
Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction : a Randomized Open-label Non-inferiority Trial
This study is testing whether using a nasogastric tube can help people with small bowel obstruction from adhesions feel better compared to not using one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06347120 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of nasogastric tube (NGT) insertion in patients with uncomplicated acute adhesive small bowel obstruction (ASBO). The study compares non-operative management with and without NGT to determine the best approach for alleviating symptoms and improving patient outcomes. Participants will be monitored for 72 hours, and the trial aims to provide insights into the management of ASBO, which is a significant public health concern. The study is conducted at multiple hospitals in France, focusing on patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with uncomplicated small bowel obstruction due to adhesions.
Not a fit: Patients with complicated presentations, such as strangulation or peritonitis, or those with recent abdominal surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of small bowel obstruction, potentially reducing the need for surgery and hospital stays.
How similar studies have performed: Previous studies have explored non-operative management of ASBO, but the specific role of NGT in this context remains under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of an obstruction believed to be secondary to adhesions (abdominal pain and distention, nausea and/or vomiting, no gas and/or stool). * Uncomplicated presentation (no signs of strangulation or peritonitis). * IV CT scan of the abdomen consistent with an uncomplicated ASBO, (performed with a pillow to raise slightly the patient. * Aged 18 or older. * Provision of written, informed consent. * Patient covered by French national health insurance. Exclusion Criteria: * An incarcerated and/or strangulated incisional hernia, colonic obstruction. * No previous abdominal operation. * Obstruction within 4 weeks after a recent operation. * Gastrointestinal neoplasm in progress. * Inflammatory bowel disease in progress. * Abdominal radiotherapy in the last 6 months. * Contraindication to intravenous contrast enhancement for the CT scan, pre-existing risks factors for pneumonitis. * Antecedent of aspiration pneumonia. * Age \> 85 years. * Orientation disturbance. * Bedridden. * Chronic cerebrovascular disease (cerebral infarction sequelae, Parkinson disease etc). * Dementia. * Gastroesophageal disorder (gastroesophageal reflux) * Pregnancy or breastfeeding. * Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision). * Patients unable to provide informed consent. * Age \<18 years.
Where this trial is running
Amiens
- Amiens Universitary Hospital — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Jean Marc Regimbeau, Pr
- Email: regimbeau.jean-marc@chu-amiens.fr
- Phone: 322 088 897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.