Ovarian Diseases
Conditions
Keywords
transgastric, NOTES, Gastrotomy, BRCA 1/2
Brief summary
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.
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.
Interventions
PROCEDUREtransgastric adnexectomy
adnexectomy transgastrically with transvaginal support
Sponsors
Heidelberg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with conversion to laparoscopy or laparotomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative well being | 6 weeks and 6 months | Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital) |
Countries
Germany
Outcome results
None listed