Trial Outcomes & Findings for Same Day Discharge After Minimally-invasive Sacrocolpopexy (NCT NCT03730103)
NCT ID: NCT03730103
Last Updated: 2020-09-25
Results Overview
The investigators wish to compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
6 weeks postoperatively
Results posted on
2020-09-25
Participant Flow
Subjects were excluded: (2) case start-times after 1:00 p.m., (1) case aborted, (1) approach changed to vaginal, (1) patient withdrew.
Participant milestones
| Measure |
Historical Control Group
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
52
|
|
Overall Study
COMPLETED
|
61
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Historical Control Group
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Overall Study
Did not meet inclusion criteria
|
0
|
5
|
Baseline Characteristics
Same Day Discharge After Minimally-invasive Sacrocolpopexy
Baseline characteristics by cohort
| Measure |
Historical Control Group
n=61 Participants
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 Participants
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 8.0 • n=39 Participants
|
62.2 Years
STANDARD_DEVIATION 8.9 • n=41 Participants
|
61.9 Years
STANDARD_DEVIATION 8.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
108 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
103 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=39 Participants
|
47 participants
n=41 Participants
|
108 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postoperativelyThe investigators wish to compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Outcome measures
| Measure |
Historical Control Group
n=61 Participants
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 Participants
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Number of Participants* With Serious Adverse Events
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postoperativelyThe incidence of patient-initiated phone calls for a surgery-related complication in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Outcome measures
| Measure |
Historical Control Group
n=61 Participants
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 Participants
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Number of Participants With One or More Patient- Initiated Phone Calls
1 phone call
|
16 Participants
|
9 Participants
|
|
Number of Participants With One or More Patient- Initiated Phone Calls
2 phone calls
|
20 Participants
|
7 Participants
|
|
Number of Participants With One or More Patient- Initiated Phone Calls
3 phone calls
|
7 Participants
|
4 Participants
|
|
Number of Participants With One or More Patient- Initiated Phone Calls
4+ phone calls
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postoperativelyThe incidence of unscheduled office visits, including voiding trials, for patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Outcome measures
| Measure |
Historical Control Group
n=61 Participants
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 Participants
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials
1 office visit
|
14 Participants
|
14 Participants
|
|
Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials
2 office visits
|
3 Participants
|
3 Participants
|
|
Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials
3 office visits
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days postoperativelyThe incidence of emergency department visits for patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Outcome measures
| Measure |
Historical Control Group
n=61 Participants
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 Participants
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Number of Participants With One or More Emergency Department Visits
|
4 Participants
|
2 Participants
|
Adverse Events
Historical Control Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Same Day Discharge Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Historical Control Group
n=61 participants at risk
The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions
|
Same Day Discharge Group
n=47 participants at risk
47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups
Same day discharge: Patients will be discharged home from the hospital on the day of her surgery.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
1.6%
1/61 • Number of events 1 • 6-weeks
|
4.3%
2/47 • Number of events 2 • 6-weeks
|
|
Surgical and medical procedures
Bowel obstruction
|
0.00%
0/61 • 6-weeks
|
2.1%
1/47 • Number of events 1 • 6-weeks
|
|
Cardiac disorders
Cardiopulmonary
|
1.6%
1/61 • Number of events 1 • 6-weeks
|
0.00%
0/47 • 6-weeks
|
|
Nervous system disorders
Neurologic injury
|
3.3%
2/61 • Number of events 2 • 6-weeks
|
0.00%
0/47 • 6-weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Lynn Borzi, Research Administrator
The Cleveland Clinic
Phone: 216-445-3158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place