Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Outcome; Diverting Ileostomy; Middle and Low Rectal Cancer; Stoma Complications
• Intervention / Treatment: Procedure: Diverting ileostomy

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Quan Wang, Prof.; Phone Number: +86-431-81875602; Email: wquan@jlu.edu.cn
• Study Contact Backup: Name: Weihua Tong; Phone Number: +86-431-81875602; Email: tongwh@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Middle and low rectal cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ileostomy group	Procedure: Diverting ileostomy; Diverting ileostomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Quan Wang, Prof., Jilin University First Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: STARS-RC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No