Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications

Inclusion criteria

Histological Confirmation:

Diagnosed with rectal adenocarcinoma confirmed by histology.

Tumor Location:

MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.

Preoperative Staging:

Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.

Bowel Obstruction:

No signs of bowel obstruction.

Neoadjuvant Chemoradiotherapy:

For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.

Previous Treatments:

Surgical History:

No previous colorectal surgery.

Biological and Immunotherapy:

No prior treatment with biological drugs (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4), or other investigational drugs.

Endocrine Therapy:

No restrictions on prior endocrine therapy.

Patient Characteristics:

Age:

Between 18 and 75 years old.

Performance Status:

ECOG performance status of 0-1 (see Appendix 3).

Life Expectancy:

Greater than 2 years.

Hematological Parameters:

WBC > 3×10^9/L; PLT > 80×10^9/L; Hb > 90 g/L.

Liver Function:

ALT and AST less than 2 times the upper limit of normal; bilirubin less than 1.5 times the upper limit of normal.

Renal Function:

Creatinine less than 1.5 times the upper limit of normal or creatinine clearance (CCr) ≥ 60 ml/min.

Exclusion criteria

Patients meeting any of the following conditions will be excluded from the study:

Need for Multiorgan Resection:

Patients requiring combined organ resection.

Preventive or Permanent Stoma:

Patients requiring preventive or permanent stoma.

Hartmann or Miles Procedures:

Patients requiring Hartmann's procedure or Miles' surgery.

Cardiac Conditions:

Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.

Uncontrolled Hypertension:

Severe hypertension that is not well controlled by medication.

Infectious Diseases:

History of HIV infection or active chronic hepatitis B or C with high viral DNA copies.

Active Tuberculosis (TB):

Subjects with active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening.

Severe Infections:

Other active clinically severe infections (according to NCI-CTC version 5.0).

Evidence of Distant Metastasis:

Preoperative evidence of distant metastasis outside the pelvis.

Cachexia and Organ Failure:

Cachexia or decompensated organ function.

Radiotherapy History:

History of pelvic or abdominal radiotherapy.

Multiple Primary Colorectal Cancers:

Presence of multiple primary colorectal cancers.

Seizure Disorders:

Patients with seizures requiring treatment (e.g., steroids or antiepileptic therapy).

History of Other Malignancies:

History of other malignancies within the past 5 years, except for cured in situ cervical cancer or basal cell carcinoma of the skin.

Substance Abuse:

Substance abuse or medical, psychological, or social conditions that could interfere with the patient's participation in the study or the evaluation of study results.

Allergies:

Known or suspected allergies to the investigational drug or any drug related to the study.

Unstable Conditions:

Any unstable condition or situation that might jeopardize patient safety and compliance.

Pregnancy or Lactation:

Women who are pregnant or breastfeeding, and women of childbearing potential not using adequate contraceptive measures.

Informed Consent:

Refusal to sign the informed consent form.