Transvaginal Diagnostic Study in Women With Pelvic Pain

Phase 1

Withdrawn

• Conditions: Pelvic Pain
• Interventions: Procedure: transvaginal diagnostic peritoneoscopy

• Registration Number: NCT00574444
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Study Start: 2008-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure	transvaginal diagnostic peritoneoscopy	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.

Primary Outcome Measures

Name	Time	Method
To determine the safety and feasibility of the procedure.	by January 2010

Secondary Outcome Measures

Name	Time	Method
Measurement of patient's post operative pain	post-operative day 1 and post-operative day 7

Trial Locations

Locations (1)

University of Missouri Columbia; 🇺🇸 Columbia, Missouri, United States