Same Day Discharge After Minimally-invasive Sacrocolpopexy

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT03730103

Run by

The Cleveland Clinic

People needed

52

Starts

2018-10-22

Expected to finish

2020-06-01

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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