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

This study is not yet open for participant recruitment.
Verified March 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Dr. med. Amadeus Hornemann, MPH, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01566955
First received: March 22, 2012
Last updated: March 27, 2012
Last verified: March 2012
History of Changes

March 22, 2012
March 27, 2012
April 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01566955 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Feasability Study of Removing the Ovaries and Fallopian Tubes
Feasability of Transgastric Adnexectomy

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Desease of the Ovaries.
Procedure: transgastric adnexectomy
adnexectomy transgastrically with transvaginal support
Other Names:
  • NOTES
  • Pure NOTES
Experimental: transgastric adnexectomy
patients are operated transgastric
Intervention: Procedure: transgastric adnexectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Not Provided
Germany
 
NCT01566955
UMM-Mannheim
No
Dr. med. Amadeus Hornemann, MPH, University of Heidelberg
University of Heidelberg
Not Provided
Study Chair: Marc Suetterlin, MD; PhD University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
University of Heidelberg
March 2012

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