NCT00574444

Transvaginal Diagnostic Study in Women With Pelvic Pain

Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2007-12-17
• Last updated: 2016-09-30

Locations

1 site across 1 country: United States