Transvaginal Diagnostic Study in Women With Pelvic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00574444|
Recruitment Status : Withdrawn (Investigator moved to another institution.)
First Posted : December 17, 2007
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Pain||Procedure: transvaginal diagnostic peritoneoscopy||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Assisted Transvaginal Endoscopic Diagnostic Peritoneoscopy in Women With Pelvic Pain|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
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.
- To determine the safety and feasibility of the procedure. [ Time Frame: by January 2010 ]
- Measurement of patient's post operative pain [ Time Frame: post-operative day 1 and post-operative day 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574444
|United States, Missouri|
|University of Missouri Columbia|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Klaus Thaler, MD||Dept. of General Surgery at UMHC|