A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

Terminated

• Conditions: Diagnostic or Therapeutic Laparoscopy
• Interventions: Device: Flexible Endoscope

• Registration Number: NCT00848575
• Lead Sponsor: University of Arkansas

Brief Summary

The culdoscopic approach will allow for equal or better visualization of female pelvic structures

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Female
• Ages 18 to 70 years old
• Ability to understand and give informed consent
• Scheduled for diagnostic or therapeutic laparoscopy for a clinical indication
• Presence of a uterus and at least one ovary at the initiation of the procedure

Exclusion Criteria

• Documented culdesac mass
• Inability to tolerate anesthesia
• Documentation of positive urine pregnancy test
• History of prior pelvic radiation
• Scheduled for emergency laparoscopy
• Any other medical or psychiatric condition that, in the opinion of the investigative team, will interfere with the ability of the participant to safely complete the study
• History of significant non-compliance with previous therapy or unwillingness to return for follow up visits
• Prior hysterectomy and/or bilateral salpingo-oophorectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 - Device	Flexible Endoscope	The principal Investigator and sub-investigators of this study will identify potential participants that attend the gynecologic oncology or gynecology clinics of UAMS. These subjects will have been scheduled for diagnostic or therapeutic laparoscopy. Based on the Inclusion Criteria and Exclusion Criteria of this study, women who are eligible for the study will be approached to participate.

Primary Outcome Measures

Name	Time	Method
Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.	02/2010

Secondary Outcome Measures

Name	Time	Method
Complications related to the procedures will be recorded and, if possible, attributed to one of the two techniques. If feasible, a comparison will be made between complications attributable to each approach.	02/2010

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States