Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

Study Overview
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Brief Summary
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Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.

Official Title
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A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer

Conditions
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Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome, Stoma Complications

Intervention / Treatment
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* Procedure: Diverting ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Necessary conditions: meet one of the following conditions Difficult pelvis: narrow pelvis (diameter of ischial tuberosity <10 cm, diameter of ischial spine <12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm2. To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc. Other conditions: Age: 18 to 75 years old, male or female; Preoperative biopsy pathological diagnosis of rectal adenocarcinoma; Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm; The clinical stage is T1-3N0-2M0; Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis ECOG score 0-2; Heart, lung, liver, and kidney functions can tolerate surgery; Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent. Exclusion Criteria: Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors; Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; Neighboring organs need to be combined with organ removal ASA grade ≥ grade IV and/or ECOG physical status score> 2 points; Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery; Have a history of severe mental illness; Pregnant or lactating women; Those with a history of taking hormone drugs; Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ileostomy group<br> | Procedure: Diverting ileostomy<br>* Diverting ileostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comprehensive complication index | comprehensive complication index, CCI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications based on Clavien-Dindo | 1 year | 
| Incidence of anastomotic leakage |  | 1 year | 
| Incidence of anastomotic stenosis |  | 1 year | 
| Stoma-related complications |  | 3 months | 
| Complications related to ileostomy reversal |  | three months after ileostomy reversal | 
| Overall Survival |  | three years after the operation |