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Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Primary Purpose

Gallstones, Appendicitis, Pelvic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Cholecystectomy
Endoscopic Appendectomy
Endoscopic Peritoneoscopy
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstones focused on measuring Gallstones, Appendicitis, Pelvic pain, Peritoneal mass

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Endoscopic Cholecystectomy

Endoscopic Appendectomy

Endoscopic Peritoneoscopy

Arm Description

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).

Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.

20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.

Outcomes

Primary Outcome Measures

Technical success
Complication

Secondary Outcome Measures

Operative time
Sexual function

Full Information

First Posted
December 22, 2009
Last Updated
August 19, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01039129
Brief Title
Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Official Title
Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
unable to recruit participants
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones, Appendicitis, Pelvic Pain
Keywords
Gallstones, Appendicitis, Pelvic pain, Peritoneal mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Cholecystectomy
Arm Type
Experimental
Arm Description
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).
Arm Title
Endoscopic Appendectomy
Arm Type
Experimental
Arm Description
Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.
Arm Title
Endoscopic Peritoneoscopy
Arm Type
Experimental
Arm Description
20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Cholecystectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Appendectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Peritoneoscopy
Intervention Description
A diagnostic peritoneoscopy with or without biopsy for any indication
Primary Outcome Measure Information:
Title
Technical success
Time Frame
intra-operative
Title
Complication
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
intra-operative
Title
Sexual function
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Teixeira, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

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Hybrid Transvaginal-Transabdominal Endoscopic Surgery

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