Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

NCT ID: NCT04776421

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-03-01

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.

Conditions

Diverting Ileostomy; Middle and Low Rectal Cancer; Functional Outcome; Stoma Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ileostomy group

Diverting ileostomy

Intervention Type: PROCEDURE

Diverting ileostomy

Interventions

Diverting ileostomy

Diverting ileostomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Wang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Jilin University First Hospital

Central Contacts

Quan Wang, Prof.

Role: CONTACT

wquan@jlu.edu.cn

+86-431-81875602

Weihua Tong

Role: CONTACT

tongwh@jlu.edu.cn

+86-431-81875602

Other Identifiers

STARS-RC02

Identifier Type: -

Identifier Source: org_study_id