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

Primary Purpose

Ovarian Diseases

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transgastric adnexectomy
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Diseases focused on measuring transgastric, NOTES, Gastrotomy, BRCA 1/2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Medical Center Mannheim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transgastric adnexectomy

Arm Description

patients are operated transgastric

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2012
Last Updated
May 26, 2015
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01566955
Brief Title
Feasability Study of Removing the Ovaries and Fallopian Tubes
Acronym
TG-Adnex
Official Title
Feasability of Transgastric Adnexectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Diseases
Keywords
transgastric, NOTES, Gastrotomy, BRCA 1/2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transgastric adnexectomy
Arm Type
Experimental
Arm Description
patients are operated transgastric
Intervention Type
Procedure
Intervention Name(s)
transgastric adnexectomy
Other Intervention Name(s)
NOTES, Pure NOTES
Intervention Description
adnexectomy transgastrically with transvaginal support
Primary Outcome Measure Information:
Title
Number of Participants with conversion to laparoscopy or laparotomy
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
postoperative well being
Description
Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital)
Time Frame
6 weeks and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Suetterlin, MD; PhD
Organizational Affiliation
University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Center Mannheim
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68135
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24434232
Citation
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.
Results Reference
background

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Feasability Study of Removing the Ovaries and Fallopian Tubes

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