Day Case Laparoscopic Sacrocolpopexy, a New Management

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT03607344
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-01-26
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The success rate of outpatient laparoscopic sacrocolpopexy	1 month post-operative	The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative adverses events	1 month post-operative	Adverses events are readmission, hospitalization at another medical hospitalization, complication and if patient has consulted her primary care practitioner or in the emergency department