Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00574444
Study type Interventional
Source University of Missouri-Columbia
Contact
Status Withdrawn
Phase Phase 1
Start date January 2008
Completion date December 2014

See also
  Status Clinical Trial Phase
Completed NCT04077801 - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed NCT03740932 - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Recruiting NCT03868137 - Multi-dose Ibuprofen Prophylaxis for IUD-insertion N/A
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Completed NCT02923245 - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound N/A
Completed NCT02547857 - Transvaginal Pelvic Ultrasound in the ED N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Active, not recruiting NCT01731470 - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) N/A
Completed NCT01421641 - Tenaculum Pain Control Study Phase 4
Completed NCT00034047 - Endometriosis : Traditional Medicine vs Hormone Therapy Phase 1/Phase 2
Completed NCT05368155 - Chronic Pelvic Pain and Education Skills Training for Women Veterans N/A
Completed NCT04179149 - Enriched Environments in Endometriosis N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT04077775 - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Recruiting NCT05926752 - Photobiomodulation for Myofascial Pelvic Pain N/A
Completed NCT02588885 - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention N/A
Completed NCT02261740 - Program to Overcome Pelvic Pain With Yoga N/A