Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ZHI-ZHONG PAN
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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.
Clareo Health | Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications
