The aim of the study is to prove technical feasibility and safety of a laparoscopic assisted transgastral appendectomy with a flexible endoscope.

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1 Trial Description Title Transgastral Appendectomy Trial Acronym TGA URL of the trial [---]* Brief Summary in Lay Language Patients which are going to be operated by appendectomy because of an acute or chronic appendicitis can be operated with a new operation using natural orifice, (Natural orifice transendolumenal Surgery = NOTES). The appendix will be removed via the stomach. Possible advantages of the operating procedure are less pain post op, a quicker recovery and a lesser risk for incisional hernia. Transvaginal and transgastral operations are currently in experimental and clinical evaluation. The aim of the study is to prove technical feasibility and safety of a laparoscopic assisted transgastral appendectomy. Brief Summary in Scientific Language The aim of the study is to prove technical feasibility and safety of a laparoscopic assisted transgastral appendectomy with a flexible endoscope. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg Secondary IDs Universal Trial Number (UTN): U Page 1 of 5

Possible advantages of the operating procedure are less pain post op, a quicker recovery and a lesser risk for incisional hernia.

2 Health condition or Problem studied ICD10: K Acute appendicitis, unspecified ICD10: K36 - Other appendicitis ICD10: K37 - Unspecified appendicitis Interventions/Observational Groups Arm 1: Laparoscopic assisted transgastral appendectomy Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Single arm study Blinding: [---]* Who is blinded: [---]* Control: Uncontrolled/Single arm Purpose: Treatment Assignment: Single (group) Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Feasibility Secondary Outcome Safety Countries of recruitment DE Locations of Recruitment Page 2 of 5

transgastral appendectomy Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Single arm study Blinding: [---]* Who is blinded:

3 Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2010/10/03 Target Sample Size: 30 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 15 Years Maximum Age: no maximum age Additional Inclusion Criteria -need for appendectomy -informed consent -BMI <30 -ASAi-II Exclusion criteria Pregnancy Prior abdominal operations -Peptic ulcers -Immunosuppression, HIV -Cirrhosis of the liver, portal hypertension -Coagulation disorders -Suspected tumour - Sepsis with organ failure - sonographic or clinical suspision of a perforation - esophageal stenosis or achalasia Addresses Page 3 of 5

appendectomy -informed consent -BMI <30 -ASAi-II Exclusion criteria Pregnancy Prior abdominal operations -Peptic ulcers -Immunosuppression, HIV -Cirrhosis of the liver, portal

4 Primary Sponsor Chriurgische Klinik Medizinische Fakultät der Universität Heidelberg Mr. Prof. Dr. med. Stefan Post Telephone: stefan.post at umm.de Contact for Scientific Queries Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg Mr. Dr. med. Georg Kähler Theodor-Kutzer-Ufer georg.kaehler at umm.de Contact for Public Queries Zentrale interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg Ms. Anja Schmitt anja.schmitt at umm.de Sources of Monetary or Material Support Page 4 of 5

de Contact for Scientific Queries Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg Mr. Dr. med.

5 Institutional budget, no external funding (budget of sponsor/pi) Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät der Universität Heidelberg Mr. Dr. med. Georg Kähler georg.kaehler at umm.de Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2013/11/01 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5

de Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2013/11/01 Trial

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