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Completed

NCT Number: NCT03607344

Day Case Laparoscopic Sacrocolpopexy, a New Management

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

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Key information

Age range

30 year–80 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort

Procedure

Patients undergoing ambulatory laparoscopic sacrocolpopexy

Primary outcomes

  1. The success rate of outpatient laparoscopic sacrocolpopexy

    Time frame: 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 outcomes

  1. Post-operative adverses events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Jul 31, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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