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IRCT20120129008861N5 IRCT 2023-01-15 Tehran University of Medical Sciences Comparison between anterior repair, resection and hand sewn-anastomosis and resection and stapled anastomosis of small intestine for closure of loop ileostomy Comparison of outcomes and complications between anterior repair, resection and hand sewn anastomosis, resection and stapled anastomosis of small intestine for reversal of loop ileostomy in patients who underwent rectal cancer resection surgery 2023-01-27 anticipated 96 Complete https://irct.ir/trial/67969 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly assigned into three groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com, Blinding description: In this double-blind study, participants, Investigator and Outcome assessor , were blind to the study. Before the surgery, the patients are randomly divided into three groups, which the patients and investigators do not know about it, and then the surgeon in the operating room is informed about the type of surgery of each patient, and the surgery is performed, and then the patients are transferred to the surgery ward. The patients are visited by the another surgeon ( investigator and outcome assessor) who is blind with the type of surgery of each patient and the information and data of the patients are collected and then the information is sent to the analyzer team. N/A Function of bowel. Intervention 1: Intervention group A: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then hand sewn anastomosis will be done. Intervention 2: Intervention group B : 32 patients randomly select and place in the anterior repair group. Anterior intestinal defect within the ileostomy site will be repaired. Intervention 3: Intervention group C: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then anastomosis will be done by the stapler. Yes - There is a plan to make this available What will be shared: The result of this study will be presented in the form of an article. When: Information can be accessed at any time. To whom: All individuals. Conditions: In scientific studies and clinical treatment of related patients. Where to obtain: Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science. Contact the person in charge who is mentioned. How to obtain: Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned. Comments:
public Dr. Seyed Mostafa Meshkati Yazd
Imam Khomeini hospital, Keshavarz blvd.
Tehran Iran (Islamic Republic of) 1234567890 +98 21 8860 7395 mostafa.meshkati@gmail.com Tehran University of Medical Sciences scientific Dr. Mohammad Reza Keramati
Imam Khomeini hospital, Keshavarz blvd
Tehran Iran (Islamic Republic of) 1234567890 +98 21 2283 3381 mr-keramati@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with a history of rectal cancer who had undergone curative low anterior resection for rectal cancer and a diverting protective loop ileostomy 15 years no limit Both history of immunodeficiency complications associated with rectal anastomosis, including anastomotic leakage, para-anastomotic sinuses previous abdominal operation K59.9 Functional intestinal disorder, unspecified Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group A: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then hand sewn anastomosis will be done. Intervention group B : 32 patients randomly select and place in the anterior repair group. Anterior intestinal defect within the ileostomy site will be repaired. Intervention group C: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then anastomosis will be done by the stapler. The first day of defecation. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits. The first day of flatus. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits. The first day of oral feeding. Timepoint: daily up to one week. Method of measurement: stariting of oral diet based on surgeons decision. Post operation early complications. Timepoint: daily up to one month. Method of measurement: question from the patient in daily ward visits. Post operation late complications. Timepoint: monthly up to 6 months. Method of measurement: question from the patient in monthly clinic visits. Researach deputy, School of Medicine, Tehran University of Medical Sciences Approved 2022-12-20 Tehran University of Medical Sciences, research ethics committees of Imam Khomeini Hospital complex 6th floor, Central building of Tehran University of Medical Sciences, Ghods St., Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)