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

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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

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.

Secondary Outcome

 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.

Condition

Vaginal Cancer

Intervention

QOL

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

27

Start Date

May 2001

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility 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:

          -  None
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Andrea Pusic, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00588081

Organization ID

01-044


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center


Study Sponsor

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


Verification Date

August 2016