Postoperative Gastrointestinal Dysfunction
Conditions
Keywords
Bowel resection, Gastrointestinal recovery, peripherally acting mu-opioid receptor antagonist, Bowel transection
Brief summary
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
Interventions
DRUGNaldemedine
Oral tablet
DRUGPlacebo
Oral tablet
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia: * partial small or large bowel resection with primary anastomosis * radical cystectomy requiring bowel transection with primary anastomosis * Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements: * early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery * early ambulation, which is defined as ambulation on Day 1 * early diet advancement on Day 1 * Planned to receive primary postoperative pain management with opioid analgesia administered by any route. * American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).
Exclusion criteria
* Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy. * Scheduled for endoscopic or laparoscopic surgery. * Complete bowel obstruction. * Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease). * More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant). * More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery. * Pregnancy or lactation. * Presence of peritoneal catheter (for example, for dialysis or chemotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2) | Up to 10 days After Surgery |
Secondary
| Measure | Time frame |
|---|---|
| Time From the End of Surgery to Time When the Discharge Order is Written | Up to 10 days After Surgery |
| Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube | Up to 10 days After Surgery |
| Percentage of Participants With Nausea on Days 1 Through 3 | Days 1 to 3 After Surgery |
| Percentage of Participants With Vomiting on Days 1 Through 3 | Days 1 to 3 After Surgery |
| Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital | From the Discharge Date (Days 1-10) up to 30 Days After Discharge |
Countries
United States
Participant flow
Pre-assignment details
This study was terminated by the Sponsor. The Sponsor terminated the study based on the assessment that an adequate number of study sites were not able to reach the planned enrollment. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Participants by arm
| Arm | Count |
|---|---|
| Naldemedine 1.25 mg Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 |
| Naldemedine 2.5 mg Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 |
| Naldemedine 5 mg Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 |
| Placebo Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)
Time frame: Up to 10 days After Surgery
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Secondary
Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital
Time frame: From the Discharge Date (Days 1-10) up to 30 Days After Discharge
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Secondary
Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube
Time frame: Up to 10 days After Surgery
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Secondary
Percentage of Participants With Nausea on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Secondary
Percentage of Participants With Vomiting on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Secondary
Time From the End of Surgery to Time When the Discharge Order is Written
Time frame: Up to 10 days After Surgery
Population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.