Transvaginal Diagnostic Study in Women With Pelvic Pain

This study has been withdrawn prior to enrollment.
(Investigator moved to another institution.)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00574444
First received: December 13, 2007
Last updated: February 10, 2010
Last verified: February 2010

December 13, 2007
February 10, 2010
January 2008
January 2010   (final data collection date for primary outcome measure)
To determine the safety and feasibility of the procedure. [ Time Frame: by January 2010 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00574444 on ClinicalTrials.gov Archive Site
Measurement of patient's post operative pain [ Time Frame: post-operative day 1 and post-operative day 7 ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Transvaginal Diagnostic Study in Women With Pelvic Pain
Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain

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.

Approximately 50% of patients with chronic pelvic pain will have a normal laparoscopy. The vast majority of women with endometriosis, chronic pelvic pain and absence of ovarian endometriomata determined by ultrasound will have revised ASRM Stage I or II (peritoneal) disease with preservation of the posterior cul-de-sac. This sparing of the posterior cul-de-sac may offer a preferable route of entry for endoscopic surgery compared to the current standard of care.

Despite all the advantages of laparoscopic surgery, it is not free of risks and pain, and creates scars, which themselves are associated with complications such as abdominal wall hernias and adhesions.

Within this scenario, a new surgical procedure has emerged, called natural orifice transluminal endoscopic surgery (NOTES). This technique uses existing orifices of the body for introducing optical systems and surgical instruments into the peritoneal cavity by avoiding penetration of the abdominal wall. The expectations are no postoperative pain, optimal cosmesis without any visable scars and shorter recovery similar to therapeutic endoscopy.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pelvic Pain
Procedure: transvaginal diagnostic peritoneoscopy
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women age 18 and older who have an indication and scheduled 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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00574444
1096837
No
Klaus Thaler, MD, Department of General Surgery at University of Missouri, Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Klaus Thaler, MD Dept. of General Surgery at UMHC
University of Missouri-Columbia
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP