AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%.

Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the exception of the publication by Sinhal which involved 111 patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

woman between 40 and 80 years old

Patient with significant prolapse POP-Q ≥ 2

BMI <30

ASA score ≤ 2

Disqualifiers

History of pelvic cancer surgery

History of prolapse surgery

History of pelvic irradiation

Laying a concomitant urethral strip

Trial design

Design model

Single group

Treatments tested in this trial

  • outpatient laparoscopic

    Procedure/Surgery

    The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.

  • outpatient laparoscopic

    Procedure/Surgery

    The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: outpatient laparoscopicExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful outpatient treatment

Successful outpatient treatment is defined by the absence of conventional inpatient admission with 24H after surgery, the indications for admission being a CHUNG Score \< 9, one perioperative complication, postoperative urinary retention requiring reinsertion of a urinary catheter

Time frame
24 hours after surgery

Secondary outcomes

1

The percentage of failure of the outpatient

The percentage of failure of the outpatient is defined by the number of patients with a CHUNG score \<9 in the outpatient department that does not allow the discharge of the patient or her admission to conventional hospitalization.

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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