Descending Perineum Syndrome: Mayo Clinic Cohort
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-003869
Sponsor Protocol Number: 12-003869
About this study
The purpose of this study is to construct the cohort of patients who have been diagnosed with descending perineum syndrome based on clinical findings and confirmed with Defecography and underwent medical, biofeedback or surgery at Mayo Clinic, Rochester from January 1, 1998 through October 31, 2013 and to compare postoperative complications (early and late) in patients who had various surgical approaches for management of this condition.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Define the cohort of women who had a new diagnosis of hernia of descending perineum syndrome at Mayo Clinic from January 1, 1998 through October 31, 2013..
- Report on various modality for diagnosis and management of descending perineum syndrome and time trends from January 1, 1998 through October 31, 2013.
- Compare postoperative complications (early and late) and long-term outcomes including recurrence of symptoms or the need for second surgery in patients who had open repair with modified sacrocolpopexy for treatment of descending perineum syndrome to other surgical treatments including Moschcowitz Procedure or other forms of obliteration of the Pouch of Douglas from January 1, 2002 through October 31, 2013..
- Compare postoperative complications (early and late) in patients who had open repair with modified sacrocolpopexy for treatment of descending perineum syndrome to a cohort of patients who underwent open abdominal sacrocolpopexy for treatment of vaginal vault prolapse without perineal descent from January 1, 2002 through October 31, 2013.
Exclusion Criteria:
- Refusal of the patient to use her medical record for research.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Christopher Klingele, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available