Feasability Study of Removing the Ovaries and Fallopian Tubes (TG-Adnex)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Amadeus Hornemann, MPH, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01566955
First received: March 22, 2012
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

The main reason for this trial is to show the feasibility of removing the ovarien and fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to look for more indications of scarless surgery and we will show that the transgastric adnexectomy can be performed in an easy way. It is necessary that there is an indication for removing the ovaries and fallopian tubes and if the patient agree we will do it instead of through the belly through the gaster and maybe with an additional inzision in the vagina. All patients with indication for adnexectomy are potential candidates.


Condition Intervention
Ovarian Diseases
Procedure: transgastric adnexectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasability of Transgastric Adnexectomy

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Number of Participants with conversion to laparoscopy or laparotomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    With the trial we want to demonstrate that the transgastric adnexectomy is possible. We will document the number of patients in which we have to change the transgastric to a laparoscopic or laparotomic operation.


Secondary Outcome Measures:
  • postoperative well being [ Time Frame: 6 weeks and 6 months ] [ Designated as safety issue: No ]
    Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital)


Enrollment: 6
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transgastric adnexectomy
patients are operated transgastric
Procedure: transgastric adnexectomy
adnexectomy transgastrically with transvaginal support
Other Names:
  • NOTES
  • Pure NOTES

Detailed Description:

We will show the feasibility for transgastric adnexectomy in 10 patients. Patients for participating in the study suffer of benign adnexal deseases and there is an indication for removing them for diagnostic, prophylactic or therapeutic reasons. A flexible gastric scope is put transgastric into the abdomen, developing an pneumoperitoneum and removing the adnexes with a monopolar knife. The adnexes then are put out of the abdomen either transvaginally after colpotomy or even transgastric. We already performed an appendectomy in 24 patients and were able to show the feasibility in acute infectios situations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Indication for adnexectomy, agreement to take part in the study

Exclusion Criteria:

  • No agreement in the trial; patients younger than 18 years of age
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01566955

Locations
Germany
University Medical Center Mannheim
Mannheim, Baden-Württemberg, Germany, 68135
Sponsors and Collaborators
Heidelberg University
Investigators
Study Chair: Marc Suetterlin, MD; PhD University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
  More Information

Publications:
Responsible Party: Dr. med. Amadeus Hornemann, MPH, Dr. Amadeus Hornemann, MPH, PhD, Heidelberg University
ClinicalTrials.gov Identifier: NCT01566955     History of Changes
Other Study ID Numbers: UMM-Mannheim
Study First Received: March 22, 2012
Last Updated: May 26, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
transgastric
NOTES
Gastrotomy
BRCA 1/2

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders

ClinicalTrials.gov processed this record on August 31, 2015