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Completed

NCT Number: NCT01566955

Feasability Study of Removing the Ovaries and Fallopian Tubes

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.

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Key information

Conditions

Ovarian Diseases Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, 68135, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transgastric adnexectomy

Procedure

adnexectomy transgastrically with transvaginal support

Other names: NOTES, Pure NOTES

Primary outcomes

  1. 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.

Secondary outcomes

  1. postoperative well being

    Time frame: 6 weeks and 6 months

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Feasability of Transgastric Adnexectomy

Acronym: TG-Adnex

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2012
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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