Transvaginal Diagnostic Study in Women With Pelvic Pain
Primary Purpose
Pelvic Pain
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
transvaginal diagnostic peritoneoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Pain focused on measuring transvaginal peritoneoscopy
Eligibility 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
Sites / Locations
- University of Missouri Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Procedure
Arm Description
Procedure/Surgery: 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.
Outcomes
Primary Outcome Measures
To determine the safety and feasibility of the procedure.
Secondary Outcome Measures
Measurement of patient's post operative pain
Full Information
NCT ID
NCT00574444
First Posted
December 13, 2007
Last Updated
September 29, 2016
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00574444
Brief Title
Transvaginal Diagnostic Study in Women With Pelvic Pain
Official Title
Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator moved to another institution.
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
transvaginal peritoneoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Procedure
Arm Type
Experimental
Arm Description
Procedure/Surgery: 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.
Intervention Type
Procedure
Intervention Name(s)
transvaginal diagnostic peritoneoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the safety and feasibility of the procedure.
Time Frame
by January 2010
Secondary Outcome Measure Information:
Title
Measurement of patient's post operative pain
Time Frame
post-operative day 1 and post-operative day 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Thaler, MD
Organizational Affiliation
Dept. of General Surgery at UMHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Transvaginal Diagnostic Study in Women With Pelvic Pain
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