NCT03607344

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

25 days

First QC Date

July 23, 2018

Last Update Submit

July 30, 2018

Conditions

Pelvic Organ Prolapse

Keywords

SacrocolpopexyDay case surgeryLaparoscopic

Outcome Measures

Primary Outcomes (1)

  • The success rate of outpatient laparoscopic sacrocolpopexy

    The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery

    1 month post-operative

Secondary Outcomes (1)

  • Post-operative adverses events

    1 month post-operative

Interventions

CohortPROCEDURE

Patients undergoing ambulatory laparoscopic sacrocolpopexy

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study cohort is selected from the investigators institution. All consecutive patients undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist surgeons at the investigators university hospital, with an ambulatory department, was enrolled.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 31, 2018

Study Start

January 1, 2016

Primary Completion

January 26, 2016

Study Completion

June 30, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07