Day Case Laparoscopic Sacrocolpopexy, a New Management

Pelvic Organ Prolapse Clinical Trial

Official title:

Day-case Laparoscopic Sacrocolpopexy, a Compelling Option in Selected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607344
• Other study ID #: URO-BASE04
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant.

Description:

Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects approximately 40% of female population. Of these 12% are symptomatic and suffer of physical and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal vault .

With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .

With rising health care cost and its inherent economic burden, safe and viable options to reduce cost must be sought.

Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe, especially in Great Britain. But the High Authority of Health in France found a delay in its development.

In view of the evolution of surgical and anesthetic techniques, and the low complication rate of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: January 26, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic anterior, apical and/or posterior compartment prolapse

• Patients with stage 2 or greater, according to the POP-Q classification

• Patients with a body mass index (BMI) < 30

• Patients with an American Society of Anesthesiologist (ASA) score < ou = 3.

Exclusion Criteria:

• Patient with prior history of pelvic cancer surgery and radiotherapy of the pelvis

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Cohort
Patients undergoing ambulatory laparoscopic sacrocolpopexy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of outpatient laparoscopic sacrocolpopexy	The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery	1 month post-operative
Secondary	Post-operative adverses events	Adverses events are readmission, hospitalization at another medical hospitalization, complication and if patient has consulted her primary care practitioner or in the emergency department	1 month post-operative