Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

• Conditions: Middle and Low Rectal Cancer; Functional Outcome; Stoma Complications; Diverting Ileostomy
• Interventions: Procedure: Diverting ileostomy

• Registration Number: NCT04776421
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2021-04
• Study Start: 2021-04-01
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08
• Primary Completion: 2022-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Necessary conditions: meet one of the following conditions

1. 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.
2. To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
3. The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.

Other conditions:

1. Age: 18 to 75 years old, male or female;
2. Preoperative biopsy pathological diagnosis of rectal adenocarcinoma;
3. Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm;
4. The clinical stage is T1-3N0-2M0;
5. Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis
6. ECOG score 0-2;
7. Heart, lung, liver, and kidney functions can tolerate surgery;
8. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.

Exclusion Criteria

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
3. Neighboring organs need to be combined with organ removal
4. ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
5. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
6. Have a history of severe mental illness;
7. Pregnant or lactating women;
8. Those with a history of taking hormone drugs;
9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ileostomy group	Diverting ileostomy	-

Primary Outcome Measures

Name	Time	Method
comprehensive complication index	1 year	comprehensive complication index, CCI

Secondary Outcome Measures

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