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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01566955
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
32
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transgastric adnexectomy
 N/A

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

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasability of Transgastric Adnexectomy
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: transgastric adnexectomy

patients are operated transgastric

Procedure: transgastric adnexectomy
adnexectomy transgastrically with transvaginal support
Other Names:
  • NOTES
  • Pure NOTES

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. postoperative well being [6 weeks and 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Mannheim Mannheim Baden-Württemberg Germany 68135

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Study Chair: Marc Suetterlin, MD; PhD, University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. med. Amadeus Hornemann, MPH, Dr. Amadeus Hornemann, MPH, PhD, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01566955
    Other Study ID Numbers:
    • UMM-Mannheim
    First Posted:
    Mar 30, 2012
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Dr. med. Amadeus Hornemann, MPH, Dr. Amadeus Hornemann, MPH, PhD, Heidelberg University
    transgastric
    NOTES
    Gastrotomy
    BRCA 1/2
    Additional relevant MeSH terms:
    Ovarian Diseases

    Study Results

    No Results Posted as of May 27, 2015