The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction (NCT05985343) | Clinical Trial Compass
CompletedPhase 4
The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
United States184 participantsStarted 2024-01-15
Plain-language summary
The aim of the study is to determine if the usage of sugammadex would reduce the time to return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction (AWR).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults \>18 years old
* Patients requiring an open ventral hernia repair with retromuscular mesh placement and at least one myofascial advancement flap
* Hernias with fascial defects \< 20cm wide
* Non-emergent cases
Exclusion Criteria:
* Known serious or severe hypersensitivity reaction to sugammadex or any of the ingredients in sugammadex.
* Hernias with fascial defects \> 20cm wide
* Concomitant treatment with a strong or moderate cytochrome P450 3A4 inhibitor (e.g., Ketoconazole and other anti-fungals, Clarithromycin, HIV protease inhibitors, diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (e.g., rifampin).
* Known small bowel obstruction (SBO) at the time of hernia repair
* Suspected SBO or at risk of recurrent SBO at the time of hernia repair - at the discretion of the staff surgeon.
* Nasogastric (NG), orogastric (OG), or gastric (eg. PEG) in place at the time of hernia repair and left in beyond the morning of the first postoperative day.
* Patients with a stoma.
* Cancer with increased risk of gastro-duodenal perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab) - at the discretion of the staff surgeon.
* Disorder that could alter the integrity of the gastrointestinal lining (e.g., Crohn's disease) - at the discretion of the staff surgeon.
* Severe hepatic failure (Child-Pā¦
What they're measuring
1
Time to GI-2 bowel function after surgery
Timeframe: From time of randomization to progression of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first