Expired Study
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New York, New York 10065


Purpose:

This study is being done to find out more about the experience women have with vaginal reconstruction. We hope to learn about their quality of life, sexual function, and body image. We would like to find out how happy women are with surgery. We also want to know what things should be changed or improved. Since you have had this surgery, we would like to ask you to take part in an interview.


Study summary:

The purpose of this study, entitled immediate vaginal reconstruction following oncologic resection: Surgical outcomes, patient satisfaction and sexual function is to determine postoperative complications, patient satisfaction, quality of life and level of sexual functioning among patients who have undergone vaginal reconstruction following tumor resection and/or pelvic exenteration.This study will have three components: 1) a chart review to determine postoperative complications and anatomic characteristics of the neo-vagina, 2) a postoperative questionnaire consisting of validated survey instruments to assess quality of life, body image and sexual function and 3) a postoperative qualitative interview to examine quality of life after vaginal reconstruction.


Criteria:

Inclusion Criteria: - Immediate partial or total vaginal reconstruction with myocutaneous or fasciocutaneous flaps, following pelvic exenteration or tumor resection at MSKCC during the study period from January 1, 1993 to, March 30, 2007. Exclusion Criteria:


Study is Available At:


Original ID:

01-044


NCT ID:

NCT00588081


Secondary ID:


Study Acronym:


Brief Title:

Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function


Official Title:

Immediate Vaginal Reconstruction Following Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrea Pusic, M.D.
Principal Investigator
Memorial Sloan Kettering Cancer Center

Study Dates

Start Date:May 2001
Completion Date:August 2016
Completion Type:Actual
Primary Completion Date:August 2016
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 9, 2016
First Received Date:December 22, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine the physical adequacy of the neo-vagina among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.
Time Frame:A single questionnaire and or interview
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine patient satisfaction, quality of life and level of sexual functioning among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.
Time Frame:Single Questionnaire and or interview
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.
Time Frame:A single questionnaire and or interview
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:QOL
Description:Those women who chose to have an interview will be scheduled for a 45 to 60 minute open-ended interview with a trained research assistant and sign consent at the time of the interview.
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Participants will receive a cover letter, questionnaire and invitation to participate in a post-operative interview.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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