The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Launched by CLAYTON PETRO · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called sugammadex can help patients recover bowel function faster after surgery for a type of hernia repair called open abdominal wall reconstruction. In this trial, researchers want to see if sugammadex is more effective than the standard treatment, which includes other medications like neostigmine and glycopyrrolate, in reversing the effects of muscle relaxants used during surgery. The goal is to determine if using sugammadex can reduce the time it takes for patients' digestive systems to start working again after their surgery.

To participate in this trial, you must be an adult over 18 years old who needs a specific type of hernia repair with certain conditions. For instance, your hernia must have a defect smaller than 20 centimeters, and the surgery must not be an emergency. However, some people may not be eligible, such as those with severe allergies to sugammadex, certain medical conditions affecting the intestines, or those who are pregnant or breastfeeding. If you join the trial, you will be monitored closely after your surgery to see how quickly your bowel function returns compared to those receiving standard treatment. This study is currently recruiting participants of all genders, aged 65 to 74 and older.

Gender

ALL

Eligibility criteria

• 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-Pugh Class C).
• • Clinically relevant hepatic failure (e.g. cirrhosis) - at the discretion of the staff surgeon.
• • Severe renal failure (GFR\<30ml/min, on dialysis, or have an arteriovenous fistula, indwelling hemodialysis catheter or peritoneal dialysis catheter) - at the discretion of the staff surgeon.
• • Pregnant or planning to become pregnant during study period.
• • Breastfeeding or planning to breastfeed during study period.
• • Clinically relevant alteration of the blood-brain-barrier - at the discretion of the staff surgeon.
• • Other contraindication to sugammadex as documented by a physician.
• • Unable to give informed consent; vulnerable populations; non-English speaking.
• • Emergent operation.
• • Undergoing minimally invasive approaches.
• • Undergoing repair with mesh placed in a position other than retromuscular.
• • Chronic opioid users, as defined by the daily use of opioids for at least 90 days within the past year
• • Inability to safely extubate the patient at the end of the surgery for any reason, as determined by the operative team.