Transvaginal Diagnostic Study in Women With Pelvic Pain

Withdrawn before enrolling · Phase 1

Conditions studied: Pelvic Pain

In brief

We propose a phase I study of laparoscopic assisted, transvaginal peritoneoscopy by using flexible endoscopy in female patients with pelvic pain. It is designed as a hybrid procedure with laparoscopy using one port for adequate safety with the ultimate goal in the future that transvaginal NOTES can replace therapeutic pelviscopy for this indication. The standard number of port sites for diagnostic laparoscopy is 2-3. By reducing the number and size of laparoscopic port, patients should already experience benefits from this hybrid procedure.

Key facts

Study ID

NCT00574444

Run by

University of Missouri-Columbia

People needed

0

Starts

2008-01-01

Expected to finish

2014-12-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women age 18 and older who have an indication and scheduled for laparoscopic peritoneoscopy.

You may not qualify if…

• Known pelvic adhesive disease or greater than stage II endometriosis or sonographic evidence of endometrioma.
• BMI over 30.
• Major comorbidities - including diabetes, myocardial infarction, congestive heart failure, stroke, history of cancer or currently undergoing chemotherapy, autoimmune disease requiring immunosuppressive or steroid therapy .
• Any primary bowel disease (IBD, sprue, obstruction, acute appendicitis, gastric bypass, etc.).
• Pregnancy.
• Any known PID, tuboovarian mass or abscess, or active sexually transmitted infection.
• Retroflexed uterus

Where it is running

• University of Missouri Columbia — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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