Feasability Study of Removing the Ovaries and Fallopian Tubes

Ovarian Diseases Clinical Trial

— TG-Adnex  

Official title:

Feasability of Transgastric Adnexectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566955
• Other study ID #: UMM-Mannheim
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: May 26, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Diseases

Intervention

Procedure:
• transgastric adnexectomy
adnexectomy transgastrically with transvaginal support

Locations

Country	Name	City	State
Germany	University Medical Center Mannheim	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with conversion to laparoscopy or laparotomy	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.	12 months	Yes
Secondary	postoperative well being	Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital)	6 weeks and 6 months	No