Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

NCT04776421 | Unknown

• 1 other identifier: STARS-RC02
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• comprehensive complication index

  comprehensive complication index, CCI

  1 year

Secondary Outcomes (6)

• Postoperative complications

  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

Study Arms (1)

ileostomy group

Procedure: Diverting ileostomy

Interventions

Diverting ileostomy PROCEDURE

Diverting ileostomy

ileostomy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Middle and low rectal cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Officials

• Quan Wang, Prof.

  Jilin University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Wang, Prof.

CONTACT

+86-431-81875602; wquan@jlu.edu.cn

Weihua Tong

CONTACT

+86-431-81875602; tongwh@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share