Ileus Clinical Trial
Official title:
Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
The primary objective is to assess the need of clamping nasogastric tubes (NG) before
removal. Outcomes of patients admitted requiring nasogastric tube decompression will be
compared. Patients with small bowel obstruction (SBO), post-operative ileus, and ileus on
admission that require nasogastric tube placement will be included in the study. The patients
will be divided into two groups when return of bowel function is suspected based on set
criteria for automatic removal of nasogastric tube versus nasogastric tube clamp trial.
Specific outcomes will be occurrence of nasogastric tube replacement, number of emeses if
any, failure of clamp trial, aspiration pneumonia, and any other unplanned outcome.
A high volume of patients are admitted to hospitals yearly for bowel obstruction/ileus
complications. Lifetime risk of small bowel obstruction varies from 0.1%-5% if patients have
not undergone abdominal surgery, but increases to 30% if the patient underwent a prior
abdominal surgery. Ileus is also a common complication in the short term post-operative
period. Both of these conditions are initially treated with nasogastric tube decompression if
the patient is having emesis.
The investigators were unable to find any literature that shows a concrete volume of
nasogastric tube output that was deemed the maximum for safe removal. Signs of return of
bowel function can indicate it is safe to remove the nasogastric tube. These include flatus,
bowel movements, decrease in nasogastric tube output amount, change of nasogastric tube
output color from bilious (green) to more gastric (yellow) or salivary (clear/foamy) quality.
Some physicians prefer to perform a clamp trial before removal of the nasogastric tube. The
duration of the trial and cutoff amount of residual drainage varies among physicians.
Regardless of the duration, the nasogastric tube is essentially stenting open the lower
esophageal sphincter while it is left in place and not connected to suction. This,
theoretically, places the patient at risk for aspiration and subsequent pneumonia.
Information in the literature appears divided in regard to aspiration risk.
This study hopefully will support the statement that it is safe to remove the nasogastric
tube with signs of bowel function, without the need for clamp trials and thus avoiding any
possible adverse outcomes associated with the trial. The investigators also anticipate that
this study will provide objective guidelines on which patients will continue to improve after
nasogastric tube removal.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00065234 -
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
|
Phase 2 | |
| Completed |
NCT01156129 -
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
|
Phase 1 | |
| Recruiting |
NCT05712525 -
Gut Recovery In Patients Following Surgery
|
||
| Completed |
NCT06338813 -
Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus
|
N/A | |
| Recruiting |
NCT05315765 -
Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
|
||
| Completed |
NCT02161367 -
Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
|
Phase 4 | |
| Completed |
NCT03711487 -
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
|
Phase 2 | |
| Completed |
NCT00528970 -
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
|
Phase 3 | |
| Completed |
NCT02836470 -
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
|
Phase 2 | |
| Completed |
NCT04100447 -
A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
|
Phase 1 | |
| Active, not recruiting |
NCT03795467 -
Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients
|
||
| Completed |
NCT01143259 -
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
|
N/A | |
| Terminated |
NCT03352414 -
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
|
Phase 2 | |
| Not yet recruiting |
NCT04305730 -
Use of Pedometer Following Radical Cystectomy
|
N/A | |
| Completed |
NCT02760290 -
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
|
N/A | |
| Active, not recruiting |
NCT02399605 -
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus
|
N/A | |
| Completed |
NCT00388258 -
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
|
Phase 3 | |
| Terminated |
NCT05470387 -
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
|
Phase 3 | |
| Completed |
NCT00205842 -
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
|
Phase 3 | |
| Enrolling by invitation |
NCT05298774 -
Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function
|
N/A |