NCT00671827

Brief Summary

The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

April 29, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

12.6 years

First QC Date

April 30, 2008

Last Update Submit

December 18, 2020

Conditions

Keywords

Gynecologic CancerCervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerUterine CancerVaginal CancerVulvar CancerQuestionnaireSurveyRobot-Assisted Surgery

Outcome Measures

Primary Outcomes (1)

  • Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases

    5 Years

Study Arms (1)

Robotic Gynecologic Surgery

Patients who have undergone or will undergo a robotic-assisted gynecologic procedure.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires each taking less than 10 minutes to complete.

Also known as: Survey
Robotic Gynecologic Surgery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Banner Arizona

Gilbert, Arizona, 85234, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsUterine NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersVaginal DiseasesVulvar Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pamela Soliman, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 5, 2008

Study Start

April 29, 2008

Primary Completion

December 17, 2020

Study Completion

December 17, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations