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.

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Dec 3, 2018

Keywords

ClinConnect Summary

The AMBULAPSE Study is looking at a specific type of surgery called laparoscopic double-mesh sacrocolpopexy, which is used to treat pelvic organ prolapse in women. Pelvic organ prolapse happens when the pelvic organs, like the bladder or uterus, drop from their normal position, often causing discomfort or other symptoms. This study is comparing the surgery done with and without the help of robotic tools to see how effective and safe it is for patients. Typically, this surgery is performed as an outpatient procedure, meaning patients can go home the same day, which is a growing trend in healthcare.

To take part in this study, women between the ages of 40 and 80 with a significant prolapse (a score of 2 or higher) and a body mass index (BMI) under 30 may be eligible. The study is currently recruiting participants, and those who qualify can expect to undergo a minimally invasive surgery with a strong track record of patient satisfaction and low complications. It’s worth noting that the trial is focused on improving outpatient care for this common procedure, as many women currently spend several days in the hospital after surgery. If you or someone you know is dealing with pelvic organ prolapse, this study could offer insight into a modern treatment option.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • woman between 40 and 80 years old
• • Patient with significant prolapse POP-Q ≥ 2
• • BMI \<30
• • ASA score ≤ 2
• • sterile ECBU
• Exclusion Criteria:
• * Criteria related to the pathology or the organ:
• • History of pelvic cancer surgery
• • History of prolapse surgery
• • History of pelvic irradiation
• • Laying a concomitant urethral strip
• • Cervico-vaginal smear test not up to date.
• • Patient pregnant or having a desire for pregnancy
• * Criteria related to concomitant treatments:
• • Cefazoline allergy
• • Taking the following medications within 48 hours
• • Plavix®
• • Vitamin K / Low Molecular Weight Healing Heparin
• • Contraindication to ambulatory care for medical reasons
• • Sleep apnea syndrome
• • Cardiopulmonary pathology
• • Psychiatric pathology
• • Hemorrhagic risk
• • Diabetes imbalanced
• • Unbalanced Hypertension