Trial Outcomes & Findings for A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504 (NCT NCT01509807)
NCT ID: NCT01509807
Last Updated: 2014-04-07
Results Overview
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Wound closure to time the discharge order is written or Day 30, whichever is sooner
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
Group 1
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
Baseline characteristics by cohort
| Measure |
Group 1
n=15 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=17 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 16.03 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 15.89 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Wound closure to time the discharge order is written or Day 30, whichever is soonerPopulation: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Total Opioid Burden
|
112.38 mg morphine equivalent
Standard Deviation 117.08
|
19.8 mg morphine equivalent
Standard Deviation 34.08
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
1\) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Health Economic Benefits - Total Cost of Hospitalization
|
9950.47 dollars
Standard Deviation 3899.04
|
6728.88 dollars
Standard Deviation 1874.89
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Health Economic Benefit - Length of Stay
|
5.1 days
Interval 2.2 to 31.9
|
3 days
Interval 0.8 to 5.0
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Incidence of Opioid-related Adverse Events
|
6 events
0.82
|
4 events
0.45
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Patient Satisfaction With Postsurgical Analgesia
|
90.91 percentage of patients
0.65
|
87.5 percentage of patients
0.83
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Patient Discharged From the Hospital for at Least 3 Days
|
11 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Readmission to Hospital Since Discharge
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Make Unplanned VIsit(s) With Any Healthcare Providers
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).
Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.
Outcome measures
| Measure |
Group 1
n=11 Participants
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=16 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Experienced Any Health Problems or Changed in Health Since Hospital Discharge
|
1 participants
|
2 participants
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=15 participants at risk
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=17 participants at risk
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
Other adverse events
| Measure |
Group 1
n=15 participants at risk
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
|
Group 2
n=17 participants at risk
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
20.0%
3/15 • Number of events 3
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
11.8%
2/17 • Number of events 2
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 2
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
5.9%
1/17 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/15
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
5.9%
1/17 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
11.8%
2/17 • Number of events 2
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Fecal incontinence
|
20.0%
3/15 • Number of events 3
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/15
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
5.9%
1/17 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/15
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
5.9%
1/17 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Number of events 4
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
17.6%
3/17 • Number of events 3
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
17.6%
3/17 • Number of events 3
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Injury, poisoning and procedural complications
Anal injury
|
13.3%
2/15 • Number of events 2
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Injury, poisoning and procedural complications
Incision site edema
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Nervous system disorders
Sinus headache
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
5.9%
1/17 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
|
Surgical and medical procedures
Incisional drainage
|
6.7%
1/15 • Number of events 1
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
0.00%
0/17
The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the planned surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place