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IRCT20120129008861N3 IRCT 2021-01-10 Tehran University of Medical Sciences Comparison of the results of ghost ileostomy versus protective ileostomy in rectal cancer. Comparison of the results of ghost ileostomy versus protective ileostomy in low anterior resection surgery, in rectal cancer undergoing neoadjuvant chemo-radiotherapy. 2019-06-21 anticipated 80 Complete https://irct.ir/trial/52413 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple Randomization; Random unit: Individual; Randomization tool: Excel; Randomization Output: 1=With Ghost Ileostomy 2=Without Ghost Ileostomy. 3 rectal cancer. Intervention 1: Control group: protective ileostomy group. Intervention 2: Intervention group: ghost ileostomy group. Yes - There is a plan to make this available What will be shared: Data will be shared after blinding of datasheet. When: Data will be shared within 6 months after publication. To whom: Data will be accessible for researchers affiliated to universities. Conditions: Data can be used for further meta-analysis after permission of the person responsible for this project. Where to obtain: Data request should be sent through email for the person responsible for this project. Dr. Mohammad Reza Keramati mr-keramati@tums.ac.ir How to obtain: Following the primary request, all the researchers will be informed by the responsible person and after permission the data will be shared. Comments:
public Marzieh Ghanbari
end of Keshavarz avnue, Gharib st, Imam khomeini hospital
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 ghanbari.mrz@gmail.com Tehran University of Medical Sciences scientific Mohammad Reza Keramati
Imam Khomeini hospital, Keshavarz blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1657 mr-keramati@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Rectal cancer patients History of previous neoadjuvant chemoradiotherapy tumor located more than 5 cm from anal verge candidate for low anterior resection surgery no limit 75 years Both difficult surgery or excessive bleeding immune suppression , steroid use , malnutrition obstruction or peritonitis ASA score >3 BMI>30 Diabetes Age >75 years incomplete doughnut at the end of surgery positive air leak test of anastomosis C20 malignant neoplasm of rectum Treatment - Surgery Treatment - Surgery Control group: protective ileostomy group Intervention group: ghost ileostomy group Anastomosis leakage. Timepoint: anastomosis leakage 1week,1,3,6 months. Method of measurement: colonoscopy. Abdomen re-explorization. Timepoint: Anytime the abdomen is re-explored for surgery. Method of measurement: Observation. Mortality. Timepoint: Time of death one year from surgery. Method of measurement: Observation. Re-admission. Timepoint: Date of re-admission 3 months after surgery. Method of measurement: Observation. Tehran University of Medical Sciences Approved 2018-04-22 Tehran university of medical sciences ethics committee Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)