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Hybrid Transvaginal-Transabdominal Endoscopic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by St. Luke's-Roosevelt Hospital Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01039129
First received: December 22, 2009
Last updated: May 12, 2014
Last verified: February 2011

December 22, 2009
May 12, 2014
December 2009
August 2011   (final data collection date for primary outcome measure)
  • Technical success [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
  • Complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01039129 on ClinicalTrials.gov Archive Site
  • Operative time [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
  • Sexual function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Hybrid Transvaginal-Transabdominal Endoscopic Surgery

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gallstones
  • Appendicitis
  • Pelvic Pain
  • Peritoneal Mass
Procedure: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.
  • Experimental: Hybrid Transvaginal-Transabdominal Endoscopic Cholecystectomy
    20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis).
    Intervention: Procedure: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
  • Experimental: Hybrid Transvaginal-Transabdominal Endoscopic Appendectomy
    20 patients in this arm will undergo appendectomy, or removal of the appendix, through this experimental approach. This arm will be composed of patients with chronic appendicitis that has abated or early acute appendicitis.
    Intervention: Procedure: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
  • Experimental: Hybrid Transvaginal-Transabdominal Endoscopic Peritoneoscopy
    20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.
    Intervention: Procedure: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic or early appendicitis
  • Symptomatic gallstones
  • Suspicious abdominal mass/nodule
  • Female
  • Age 18-60 years
  • ASA Class I or II

Exclusion Criteria:

  • Pregnant women
  • History of previous abdominal, pelvic, or vaginal surgery
  • History of previous abdominal or pelvic radiation therapy
  • History of fibroid uterus
  • History of endometriosis
  • History of large ovarian cyst
  • History of unexplained vaginal bleeding or dyspareunia
Female
18 Years to 60 Years
No
Contact: Julio Teixeira, MD 212-523-2184 jteixeira@chpnet.org
United States
 
NCT01039129
SLR IRB#09-136
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Not Provided
Principal Investigator: Julio Teixeira, MD St. Luke's-Roosevelt Hospital Center, Department of Surgery
St. Luke's-Roosevelt Hospital Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP