Clinical trial NCT04776421: Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
Official title: A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diverting Ileostomy
Middle and Low Rectal Cancer
Functional Outcome
Stoma Complications
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle and low rectal cancer patients

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 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.

Primary outcomes:
measure: comprehensive complication index
timeFrame: 1 year
Secondary outcomes:
measure: Postoperative complications
timeFrame: 1 year
measure: Incidence of anastomotic leakage
timeFrame: 1 year
measure: Incidence of anastomotic stenosis
timeFrame: 1 year
measure: Stoma-related complications
timeFrame: 3 months
measure: Complications related to ileostomy reversal
timeFrame: three months after ileostomy reversal
measure: Overall Survival
timeFrame: three years after the operation
Other outcomes:
Locations:
Study officials:
affiliation: Jilin University First Hospital
name: Quan Wang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: