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:

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01039129

First received: December 22, 2009

Last updated: February 22, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2009

Last Updated Date

February 22, 2011

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Technical success [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
Complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01039129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Operative time [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
Sexual function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Official Title ^ICMJE

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gallstones
Appendicitis
Pelvic Pain
Peritoneal Mass

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Julio Teixeira, MD

212-523-2184

jteixeira@chpnet.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01039129

Other Study ID Numbers ^ICMJE

SLR IRB#09-136

Has Data Monitoring Committee

Responsible Party

Julio Teixeira, MD, St. Luke's-Roosevelt Hospital Center, Department of Surgery

Study Sponsor ^ICMJE

St. Luke's-Roosevelt Hospital Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Julio Teixeira, MD

St. Luke's-Roosevelt Hospital Center, Department of Surgery

Information Provided By

St. Luke's-Roosevelt Hospital Center

Verification Date

February 2011

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

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