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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Gallstones
Appendicitis
Pelvic Pain
Procedure: Endoscopic Cholecystectomy
Procedure: Endoscopic Appendectomy
Procedure: Endoscopic Peritoneoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

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

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

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039129

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01039129     History of Changes
Other Study ID Numbers: SLR IRB#09-136
Study First Received: December 22, 2009
Last Updated: August 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Gallstones
Appendicitis
Pelvic pain
Peritoneal mass

Additional relevant MeSH terms:
Appendicitis
Gallstones
Pelvic Pain
Biliary Tract Diseases
Calculi
Cecal Diseases
Cholecystolithiasis
Cholelithiasis
Digestive System Diseases
Gallbladder Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Intraabdominal Infections
Pain
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2015