Day Case Laparoscopic Sacrocolpopexy, a New Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Keywords

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Sacrocolpopexy Day case surgery Laparoscopic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cohort

Patients undergoing ambulatory laparoscopic sacrocolpopexy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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URO-BASE04

Identifier Type: -

Identifier Source: org_study_id