Hybrid Transvaginal-Transabdominal Endoscopic Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01039129|
Recruitment Status : Withdrawn (unable to recruit participants)
First Posted : December 24, 2009
Last Update Posted : August 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gallstones Appendicitis Pelvic Pain||Procedure: Endoscopic Cholecystectomy Procedure: Endoscopic Appendectomy Procedure: Endoscopic Peritoneoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hybrid Transvaginal-Transabdominal Endoscopic Surgery|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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).
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.
Experimental: Endoscopic Appendectomy
Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.
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
Experimental: Endoscopic Peritoneoscopy
20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.
Procedure: Endoscopic Peritoneoscopy
A diagnostic peritoneoscopy with or without biopsy for any indication
- Technical success [ Time Frame: intra-operative ]
- Complication [ Time Frame: 1 month ]
- Operative time [ Time Frame: intra-operative ]
- Sexual function [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039129
|United States, New York|
|St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10025|
|Principal Investigator:||Julio Teixeira, MD||St. Luke's-Roosevelt Hospital Center, Department of Surgery|