Day Case Laparoscopic Sacrocolpopexy, a New Management

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

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

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Cohort

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study cohort is selected from the investigators institution. All consecutive patients undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist surgeons at the investigators university hospital, with an ambulatory department, was enrolled.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 26, 2016
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic; Sacrocolpopexy; Day case surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: URO-BASE04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No