Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Sponsor

St. Luke's-Roosevelt Hospital Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01039129

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallstones Appendicitis Pelvic Pain	Procedure: Endoscopic Cholecystectomy Procedure: Endoscopic Appendectomy Procedure: Endoscopic Peritoneoscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Technical success [intra-operative]
Complication [1 month]

Secondary Outcome Measures

Operative time [intra-operative]
Sexual function [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's-Roosevelt Hospital Center	New York	New York	United States	10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01039129

Other Study ID Numbers:

SLR IRB#09-136

First Posted:

Dec 24, 2009

Last Update Posted:

Aug 21, 2015

Last Verified:

Aug 1, 2015

Keywords provided by St. Luke's-Roosevelt Hospital Center

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2015