A Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer
This study aims to evaluate the safety and efficacy of radical colectomy with hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES). This is a prospective, single-arm, multicenter, uncontrolled, open-label phase II study in 55 eligible subjects with resectable colon cancer. After informed consent, patients will be sent to have hvNOTES radical colectomy by surgeons with good experience in laparoscopic colorectal surgery. Patients' demographic, operative detail and postoperative outcomes including conversion to open surgery, operating time, blood loss, pain score, resumption of gastrointestinal function, postoperative complications, length of hospital stay, sexual function, quality of recovery, recurrence rate, recurrence patterns, relapse-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate safety, functional outcomes or oncologic outcomes of hvNOTES colectomy.
• Female.
• Age: over 18 and below 80 years old.
• BMI \< 28 kg/m\^2.
• American Society of Anesthesiologists score of class I to III.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Colonic adenocarcinoma by endoscopy with biopsy.
• Tumor size ≤ 5 cm.
• Involving a single colon segment:
∙ Right colon from the ileocecal valve up to and including the hepatic flexure.
‣ Left colon from the splenic flexure to the junction of the sigmoid and descending colon.
‣ Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate).
• Clinical stage cT1, T2, or T3, cN0, N1, N2.
⁃ No advanced local disease that renders laparoscopic resection impossible.
⁃ No transverse colon cancer (between distal hepatic flexure and proximal splenic flexure).
⁃ No distant metastasis in preoperative studies.
⁃ Complete preoperative colonoscopy demonstrating no synchronous colon cancers.
⁃ Require one of the following elective operations that may be safely performed by current techniques:
• Right hemicolectomy
∙ Left hemicolectomy
∙ Subtotal colectomy
∙ Sigmoid colectomy
⁃ Patients who agree with participating in the clinical study with informed consents. And with willingness and ability to comply with the requirements of the study protocol including follow-up.