Using sugammadex to improve bowel function after abdominal wall surgery

The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

This study is testing if a medication called sugammadex can help people recovering from abdominal wall surgery get their bowel function back to normal faster than the usual treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05985343 on ClinicalTrials.gov

What this trial studies

This study investigates whether sugammadex, a medication used for reversing neuromuscular blockade, can reduce the time it takes for bowel function to return after open abdominal wall reconstruction compared to the standard treatment of neostigmine and glycopyrrolate. The primary focus is on patients undergoing ventral hernia repair with retromuscular mesh placement. The study aims to determine if sugammadex can decrease the incidence of postoperative ileus and shorten hospital stays by facilitating quicker bowel recovery. The outcomes will be measured by the time until the first bowel movement and the tolerance of solid food post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old requiring open ventral hernia repair with specific surgical criteria.

Not a fit: Patients with larger hernias, known bowel obstructions, or those with hypersensitivity to sugammadex may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to faster recovery of bowel function and shorter hospital stays for patients undergoing abdominal wall reconstruction.

How similar studies have performed: While the use of sugammadex in this context is novel, similar studies have shown promising results in improving recovery times in other surgical settings.

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.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Clayton C Petro, MD — The Cleveland Clinic
• Study coordinator: Clayton C Petro, MD

Conditions Hernia, Ventral; Ileus