Feasability Study of Removing the Ovaries and Fallopian Tubes
TG-Adnex
Feasability of Transgastric Adnexectomy
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 30, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 27, 2015
May 1, 2015
2.7 years
March 22, 2012
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
postoperative well being
6 weeks and 6 months
Study Arms (1)
transgastric adnexectomy
EXPERIMENTALpatients are operated transgastric
Interventions
adnexectomy transgastrically with transvaginal support
Eligibility Criteria
You may qualify if:
- Indication for adnexectomy, agreement to take part in the study
You may not qualify if:
- No agreement in the trial; patients younger than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68135, Germany
Related 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.
PMID: 24434232BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Suetterlin, MD; PhD
University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Amadeus Hornemann, MPH, PhD
Study Record Dates
First Submitted
March 22, 2012
First Posted
March 30, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 27, 2015
Record last verified: 2015-05