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NCT Number: NCT06347120

Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction

Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.

The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :

* OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours; * NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.

NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.

However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.

Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.

To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens Universitary Hospital

Amiens, France

Location status: Recruiting

Location contact

Aiham Ghazali, Pr

SUB_INVESTIGATOR

Aurelien Venara, MD

PRINCIPAL_INVESTIGATOR

Christophe Tresallet, MD

PRINCIPAL_INVESTIGATOR

Corina Iederan, MD

PRINCIPAL_INVESTIGATOR

David Fuks, MD

PRINCIPAL_INVESTIGATOR

Fabrice Muscari, MD

PRINCIPAL_INVESTIGATOR

François Mauvais, MD

PRINCIPAL_INVESTIGATOR

Jérémie Lefevre, MD

PRINCIPAL_INVESTIGATOR

Lilian Schwarz, MD

PRINCIPAL_INVESTIGATOR

Muriel Mathonnet, MD

PRINCIPAL_INVESTIGATOR

Pablo Ortega deballon, MD

PRINCIPAL_INVESTIGATOR

Thierry Yzet, Pr

SUB_INVESTIGATOR

Zaher Lakkis, MD

PRINCIPAL_INVESTIGATOR

charles sabbagh, Pr

SUB_INVESTIGATOR

jean marc Regimbeau, Pr

CONTACT

[email protected]

+33 3 22 08 89 05

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasogastric tube

Procedure

nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.

NOM without NGT insertion

Other

intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h

Primary outcomes

  1. Decrease of complication rate in patient without NGT group compared to control group

    Time frame: 3 years

    Decrease of complication rate in patient without NGT group compared to control group

Secondary outcomes

  1. aspiration pneumonia rate in both patient groups

    Time frame: 3 years

    aspiration pneumonia rate in both patient groups

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Marc Regimbeau, Pr

CONTACT

[email protected]

322 088 897

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Abbeville Hospital Center
  • CHU de Rouen - Accueil
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier de Beauvais
  • Hospital Avicenne
  • Hôpital Cochin
  • Saint Antoine University Hospital
  • University Hospital, Angers
  • University Hospital, Limoges
  • University Hospital, Toulouse

Registry information

Official study title

Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction : a Randomized Open-label Non-inferiority Trial

Acronym: BOWNTI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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