Transvaginal Diagnostic Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pelvic Pain	Procedure: transvaginal diagnostic peritoneoscopy	Phase I

MedlinePlus related topics:

Endoscopy Pelvic Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment

Official Title:	Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

To determine the safety and feasibility of the procedure. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]
The number of laparoscopic port sites required for diagnostic procedures. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]
Visualization of pelvic and intra-abdominal anatomy. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]
Ease and accuracy of biopsy. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Measurement of patient's post operative pain: [ Time Frame: by January 2010 ] [ Designated as safety issue: No ]
Incidence intra- and postoperative complications. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]
Measurement of patient's perception of cosmesis. [ Time Frame: by January 2010 ] [ Designated as safety issue: No ]
Measurement of time required to perform transvaginal access and exploration. [ Time Frame: by January 2010 ] [ Designated as safety issue: No ]
Measurement of intra-abdominal insufflation pressure required to produce adequate visualization of pelvic and abdominal structures. [ Time Frame: by January 2010 ] [ Designated as safety issue: No ]
Measure of angle of Trendelenberg required to clear intestine/omentum from the pelvis. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010

Intervention Details:

For patients with pelvic pain, a transvaginal procedure can be done to explore the abdomen. Entering through the vagina, will hopefully decrease the number of ports in the abdomen and decrease pain and healing time.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574444

Contacts


Contact: Klaus Thaler, MD	573-882-9041	thalerk@health.missouri.edu

Contact: Brent Miedema, MD	573-882-9041	miedemab@health.missouri.edu

Locations


United States, Missouri
	University of Missouri Columbia	Not yet recruiting
	Columbia, Missouri, United States, 65212

Sponsors and Collaborators

University of Missouri-Columbia

Investigators


Principal Investigator:	Klaus Thaler, MD	Dept. of General Surgery at UMHC

More Information

Responsible Party:	Department of General Surgery at University of Missouri, Columbia ( Klaus Thaler, MD )
Study ID Numbers:	1096837
First Received:	December 13, 2007
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00574444
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

transvaginal peritoneoscopy

Study placed in the following topic categories:

Signs and Symptoms

Pelvic Pain

Pain

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of Missouri-Columbia
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00574444