Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347120
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-19
Brief Title:
Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction a Randomized Open-label Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOWNTI
Brief Summary:
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 n96 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 patientscare suffering from ASBO
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 n96 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 patientscare suffering from ASBO
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None