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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566955
First Posted: March 30, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. med. Amadeus Hornemann, MPH, Heidelberg University
March 22, 2012
March 30, 2012
May 27, 2015
April 2012
December 2014   (Final data collection date for primary outcome measure)
Number of Participants with conversion to laparoscopy or laparotomy [ Time Frame: 12 months ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Diseases
Procedure: transgastric adnexectomy
adnexectomy transgastrically with transvaginal support
Other Names:
  • NOTES
  • Pure NOTES
Experimental: transgastric adnexectomy
patients are operated transgastric
Intervention: Procedure: transgastric adnexectomy
Hornemann A, Suetterlin M, Trunk MJ, Gerhardt A, Kaehler G. Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY). Int J Gynaecol Obstet. 2014 Apr;125(1):86-8. doi: 10.1016/j.ijgo.2013.08.024. Epub 2014 Jan 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
December 2014
December 2014   (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01566955
UMM-Mannheim
No
Not Provided
Not Provided
Dr. med. Amadeus Hornemann, MPH, Heidelberg University
Heidelberg University
Not Provided
Study Chair: Marc Suetterlin, MD; PhD University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
Heidelberg University
May 2015

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