Feasability Study of Removing the Ovaries and Fallopian Tubes

Not Applicable

Completed

• Conditions: Ovarian Diseases
• Interventions: Procedure: transgastric adnexectomy

• Registration Number: NCT01566955
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-30
• Study Start: 2012-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transgastric adnexectomy	transgastric adnexectomy	patients are operated transgastric

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
postoperative well being	6 weeks and 6 months	Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital)

Trial Locations

Locations (1)

University Medical Center Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany