Robotic Urogynecological Surgery: Hospital Stay and Perio... | NCT01033786

Studies
Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications

NCT01033786

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Oct 3, 2024Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Urogynecology

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 15, 2009

First Submission Date that Met QC Criteria

Dec 15, 2009

First Posted Date

Dec 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2024

Last Update Posted Date

Oct 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.		09/01/07 - 09/01/08

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008.

Exclusion Criteria:

Any women not meeting inclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women who underwent DaVinci-assisted laparscopic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunhilde Buchsbaum, MD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester		Rochester	New York	14642	United States