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Traditional lateral ileostomy vs percutaneous ileostomy by exclusion probe for the protection of the extraperitoneal colo-rectal anastomosis (Ileostomia laterale tradizionale vs ileostomia percutanea escludente su sonda dedicata a protezione della anastomosi colorettali extraperitoneali)

ABSTRACT: Background and study aims Rectal cancer is cancer of the back passage (rectum). Surgery to treat rectal cancer involves the resection (removal) of the rectum and attachment of the colon to the remainder of the rectum (colorectal anastomosis). A conventional ileostomy is usually performed, where the small intestine is diverted through an opening in the abdomen (stoma), which requires a second operation to be closed. The aim of this study is to assess the effectiveness and safety of percutaneous ileostomy by probe, where a tube is inserted into the small intestine which can be removed without a second operation. Who can participate? Patients aged over 18 with rectal cancer undergoing surgery What does the study involve? Participants are randomly allocated to undergo either conventional ileostomy or percutaneous ileostomy by probe. Anastomotic leakages and complications due to the placement and removal of the probe are assessed.

DISEASE(S): Colorectal Cancer

PROVIDER: 2427109 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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. Primary outcome(s): 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. Study Design: 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 se

Dataset Information

Traditional lateral ileostomy vs percutaneous ileostomy by exclusion probe for the protection of the extraperitoneal colo-rectal anastomosis (Ileostomia laterale tradizionale vs ileostomia percutanea escludente su sonda dedicata a protezione della anastomosi colorettali extraperitoneali)

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