Same Day Discharge After Minimally-invasive Sacrocolpopexy

NCT03730103 | Completed Results

• 1 other identifier: 18-563
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants* With Serious Adverse Events

  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.

  6 weeks postoperatively

Secondary Outcomes (3)

• Number of Participants With One or More Patient- Initiated Phone Calls

  6 weeks postoperatively

• Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials

  6 weeks postoperatively

• Number of Participants With One or More Emergency Department Visits

  30 days postoperatively

Study Arms (2)

Historical control group

NO INTERVENTION

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

EXPERIMENTAL

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

Other: Same day discharge

Interventions

Same day discharge OTHER

Patients will be discharged home from the hospital on the day of her surgery.

Same day discharge group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: All participants are women having surgery for pelvic organ prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Hickman LC, Paraiso MFR, Goldman HB, Propst K, Ferrando CA. Same-Day Discharge After Minimally Invasive Sacrocolpopexy Is Feasible, Safe, and Associated With High Patient Satisfaction. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):e614-e619. doi: 10.1097/SPV.0000000000000998.

  PMID: 33411456 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lynn Borzi, Research Administrator
• Organization: The Cleveland Clinic

borzil@ccf.org

216-445-3158

Study Officials

• Lisa C Hickman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study with historical controls

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: November 5, 2018
• Study Start: October 22, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)