A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy

NCT00848575 | Terminated

• 1 other identifier: 99075
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diagnostic or Therapeutic Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.

  02/2010

Secondary Outcomes (1)

• 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

Study Arms (1)

Group 1 - Device

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.

Device: Flexible Endoscope

Interventions

Flexible Endoscope DEVICE

Group 1 - Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from among women attending the gynecologic clinics or gynecologic oncology clinic of UAMS. Subjects from all races and ethnicities may participate. No children (aged \<18 years) are to be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Burnett, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

US (1)