Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04776421
Other study ID # STARS-RC02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 1, 2023

Study information

Verified date April 2021
Source The First Hospital of Jilin University
Contact Quan Wang, Prof.
Phone +86-431-81875602
Email wquan@jlu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date March 1, 2023
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Procedure:
Diverting ileostomy
Diverting ileostomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Outcome

Type Measure Description Time frame Safety issue
Primary comprehensive complication index comprehensive complication index, CCI 1 year
Secondary Postoperative complications Postoperative complications based on Clavien-Dindo 1 year
Secondary Incidence of anastomotic leakage 1 year
Secondary Incidence of anastomotic stenosis 1 year
Secondary Stoma-related complications 3 months
Secondary Complications related to ileostomy reversal three months after ileostomy reversal
Secondary Overall Survival three years after the operation
See also
  Status Clinical Trial Phase
Recruiting NCT06042946 - Microsurgical Resection of Intramedullary Spinal Cord Metastases
Completed NCT04642651 - Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty Phase 4
Terminated NCT05034341 - Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery? N/A
Completed NCT03948542 - Fractures of the Humeral Shaft With Primary Radial Nerve Palsy