N/A
N=113
Same Day Discharge After Minimally-invasive Sacrocolpopexy
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03730103 ↗Enrolled (actual)
113
Serious AEs
6.5%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants* With Serious Adverse Events — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Same day discharge (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants* With Serious Adverse Events |
4; 3 | — |
| SECONDARY Number of Participants With One or More Patient- Initiated Phone Calls |
16; 9; 20; 7; 7; 4 | — |
| SECONDARY Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials |
14; 14; 3; 3; 0; 3 | — |
| SECONDARY Number of Participants With One or More Emergency Department Visits |
4; 2 | — |
Summary
This is a prospective cohort study evaluating safety, cost and patient satisfaction with SDD for patients undergoing minimally invasive sacrocolpopexy for pelvic organ prolapse. A prospectively collected, historical control group who underwent the same surgical procedure will be utilized to compare these outcomes when applicable. SDD will be facilitated in part by a utilizing novel patient education video created for this study and implementing an ERAS pathway. All patients meeting eligibility criteria will be approached for study participation. Outcomes will be assessed on POD 0/1 and at the routine post-operative follow up visit, generally at 6 weeks after surgery.
Eligibility Criteria
Inclusion Criteria
- Age <80 years old
- Preoperative American Society of Anesthesiologists grade I (normal healthy patient) or II (mild systemic disease)
- Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
- Caretaker at home for at least 24 hours post-operatively
- Able to speak and read English
- Has decision-making capacity and able to provide consent for research participation
Exclusion Criteria
- Laparoscopic, robotic, or open abdominal surgical procedures that require an overnight admission. This may be due to unanticipated additional intraoperative procedures or surgical complications such as unintentional cystotomy or enterotomy, hemorrhage, or anesthetic complication.
- Patients undergoing concomitant laparoscopic colorectal procedures or anal sphincteroplasty
- Surgery start time after 1: 00PM, as previous studies have determined this is associated with a decreased likelihood of SDD3,14
- Pregnancy or positive hCG testing, which is standard of care preoperative testing
Data sourced from ClinicalTrials.gov (NCT03730103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.