Feasability Study of Removing the Ovaries and Fallopian Tubes (TG-Adnex)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasability of Transgastric Adnexectomy|
- 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.
- 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)
|Study Start Date:||April 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: transgastric adnexectomy
patients are operated transgastric
Procedure: transgastric adnexectomy
adnexectomy transgastrically with transvaginal support
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566955
|University Medical Center Mannheim|
|Mannheim, Baden-Württemberg, Germany, 68135|
|Study Chair:||Marc Suetterlin, MD; PhD||University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology|