Status:
UNKNOWN
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Diverting Ileostomy
Middle and Low Rectal Cancer
Eligibility:
All Genders
18-75 years
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04776421
Start Date
April 1 2021
End Date
March 1 2023
Last Update
April 8 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.