Ovarian DiseasesTG-AdnexNCT01566955
Feasability Study of Removing the Ovaries and Fallopian Tubes
A study testing transgastric adnexectomy in people with Ovarian Diseases, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Diseases
- What is being tested?
- transgastric adnexectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for adnexectomy, agreement to take part in the study
Who cannot join
- No agreement in the trial; patients younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68135
About this study
Official title: Feasability of Transgastric Adnexectomy
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.
Read the 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.
- Conditions
- Ovarian Diseases
- Being tested
- transgastric adnexectomy
- Keywords
- transgastric, NOTES, Gastrotomy, BRCA 1/2
- Medical subject headings
- Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transgastric adnexectomyProcedure or surgery
Also called NOTES, Pure NOTES
adnexectomy transgastrically with transvaginal support
| Study group | Role | What they receive |
|---|---|---|
| transgastric adnexectomy | Experimental | patients are operated transgastric Receives: Procedure: transgastric adnexectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
postoperative well being
Postoperative well being after 6 weeks and after 6 months (standardized questionaire of our hospital)
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Amadeus Hornemann, MPH, Heidelberg University
- Investigators
- Marc Suetterlin, MD; PhD, Study chair, University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566955
- Sponsor's protocol ID
- UMM-Mannheim
- Acronym
- TG-Adnex
- Status last verified
- May 2015
- First submitted
- 22 Mar 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24434232
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability of Transgastric Adnexectomy
- ClinicalTrials.gov ID
- NCT01566955
- Acronym / sponsor ID
- TG-Adnex / UMM-Mannheim
- Conditions
- Ovarian Diseases
- Keywords
- transgastric, NOTES, Gastrotomy, BRCA 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transgastric adnexectomy | Experimental | Procedure: transgastric adnexectomypatients are operated transgastric |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for adnexectomy, agreement to take part in the study
Key exclusion criteria (1 listed)
- No agreement in the trial; patients younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transgastric adnexectomyAlso: NOTES, Pure NOTESadnexectomy transgastrically with transvaginal support | Procedure or surgery | transgastric adnexectomy |
Primary outcome
Number of Participants with conversion to laparoscopy or laparotomy
Time frame: 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.
1 secondary outcome
postoperative well being
Time frame: 6 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 24434232Hornemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Suetterlin, MD; PhD study chair
University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transgastric adnexectomy in people with Ovarian Diseases, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with conversion to laparoscopy or laparotomy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.