Clinical Trial: Transvaginal Diagnostic Study in Women With Pelvic Pain

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Missouri-Columbia

Current Primary Outcome: To determine the safety and feasibility of the procedure. [ Time Frame: by January 2010 ]

Original Primary Outcome:

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


Current Secondary Outcome: Measurement of patient's post operative pain [ Time Frame: post-operative day 1 and post-operative day 7 ]

Original Secondary Outcome:

  • Measurement of patient's post operative pain: [ Time Frame: by January 2010 ]
  • Incidence intra- and postoperative complications. [ Time Frame: by January 2010 ]
  • Measurement of patient's perception of cosmesis. [ Time Frame: by January 2010 ]
  • Measurement of time required to perform transvaginal access and exploration. [ Time Frame: by January 2010 ]
  • Measurement of intra-abdominal insufflation pressure required to produce adequate visualization of pelvic and abdominal structures. [ Time Frame: by January 2010 ]
  • Measure of angle of Trendelenberg required to clear intestine/omentum from the pelvis. [ Time Frame: by January 2010 ]


Information By: University of Missouri-Columbia

Dates:
Date Received: December 13, 2007
Date Started: January 2008
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016