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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This study has been withdrawn prior to enrollment.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
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Measurement of patient's post operative pain [ Time Frame: post-operative day 1 and post-operative day 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

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

Locations
United States, Missouri
University of Missouri Columbia
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

No publications provided

Responsible Party: Klaus Thaler, MD, Department of General Surgery at University of Missouri, Columbia
ClinicalTrials.gov Identifier: NCT00574444     History of Changes
Other Study ID Numbers: 1096837
Study First Received: December 13, 2007
Last Updated: February 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
transvaginal peritoneoscopy

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013