rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 80 years; 2. Pathologically confirmed rectal adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma; 3. Tumor distance from the anal verge <= 7cm or from the dentate line <= 5cm; 4. Patients who have received preoperative chemoradiotherapy and are assessed as eligible for surgical resection after treatment; 5. After preoperative chemoradiotherapy, imaging (MRI/CT) evaluation shows ycT0 - 3N0 - 2M0; 6. Preoperative clinical and imaging assessment shows M1a stage, but the primary rectal lesion can be included in the study if the metastatic lesion can be resected simultaneously or in stages; 7. Good anal sphincter function, with a Wexner incontinence score <= 5; 8. Expected to undergo sphincter - saving surgery and suitable for anastomotic reconstruction; 9. Patients and their families understand the study and voluntarily sign the consent form.
Exclusion criteria
Exclusion criteria: 1.Imaging shows tumor invasion of the external sphincter, levator ani, or puborectalis (T4 stage per anal canal cancer staging); 2.Preoperative clinical and imaging evaluation indicates M1b - M1c stage; 3.History of pelvic radiotherapy or other malignancies; 4.Severe comorbidities (e.g., cardiac, hepatic, or renal insufficiency), ASA score =3; 5.Pregnant or breastfeeding women; 6.Psychiatric illness or poor compliance, making follow - up impossible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of anastomotic leakage; | — |
Secondary
| Measure | Time frame |
|---|---|
| LARS Scoring Scale;The value of Carcinoembryonic Antigen (CEA) ;Tumor staging (T, N, M, overall TNM staging) ;The rate of anastomotic stenosis;The local tumor recurrence rate;The distant metastasis rate;The rate of permanent stoma; | — |
Countries
China
Contacts
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University