Hybrid Transvaginal-Transabdominal Endoscopic Surgery

This study has been withdrawn prior to enrollment.
(unable to recruit participants)
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01039129
First received: December 22, 2009
Last updated: August 19, 2015
Last verified: August 2015

December 22, 2009
August 19, 2015
December 2009
October 2012   (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
  • Procedure: Endoscopic Cholecystectomy
    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.
  • Procedure: Endoscopic Appendectomy
    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
  • Procedure: Endoscopic Peritoneoscopy
    A diagnostic peritoneoscopy with or without biopsy for any indication
  • Experimental: 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: Endoscopic Cholecystectomy
  • Experimental: Endoscopic Appendectomy
    Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.
    Intervention: Procedure: Endoscopic Appendectomy
  • Experimental: Endoscopic Peritoneoscopy
    20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.
    Intervention: Procedure: Endoscopic Peritoneoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2012
October 2012   (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 information is only displayed when the study is recruiting subjects
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
August 2015

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