COMPLETED

The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction

Quick Facts

Study Start:2024-01-15

Study Completion:2025-06-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05985343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Clayton C Petro, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Clayton Petro

Clayton C Petro, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-15

Study Completion Date2025-06-02

Study Record Updates

Study Start Date2024-01-15

Study Completion Date2025-06-02

Terms related to this study

Additional Relevant MeSH Terms

Hernia, Ventral
Ileus