Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer

Renmin Hospital of Wuhan University55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer Natural Orifice Transluminal Endoscopic Surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female. 2. Age: over 18 and below 80 years old. 3. BMI \< 28 kg/m\^2. 4. American Society of Anesthesiologists score of class I to III. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Colonic adenocarcinoma by endoscopy with biopsy. 7. Tumor size ≤ 5 cm. 8. Involving a single colon segment: 1. Right colon from the ileocecal valve up to and including the hepatic flexure. 2. Left colon from the splenic flexure to the junction of the sigmoid and descending colon. 3. Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate). 9. Clinical stage cT1, T2, or T3, cN0, N1, N2. 10. No advanced local disease that renders laparoscopic resection impossible. 11. No transverse colon cancer (between distal hepatic flexure and proximal splenic flexure). 12. No distant metastasis in preoperative studies. 13. Complete preoperative colonoscopy demonstrating no synchronous colon cancers. 14. Require one of the following elective operations that may be safely performed by current techniques: 1. Right hemicolectomy 2. Left hemicolectomy 3. Subtotal colectomy 4. Sigmoid colectomy 15. 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. Exclusion Criteria: 1. Patients who have never experienced complete sexual intercourse before the operation. 2. Previous intestinal surgery with any cause. 3. cT4 tumor. 4. Complications of colon cancer (bleeding, obstruction, or perforation). 5. Previous neoadjuvant chemotherapy or radiotherapy for colon cancer. 6. Patients who are diagnosed with other malignancies within 5 years. 7. Vulnerable patients. 8. Vaginal stenosis. 9. Prior reconstructive surgery of the vagina not including hysterectomy. 10. Unstable angina or myocardial infarction within the past 6 months. 11. Cerebrovascular accident within the past 6 months. 12. Continuous systemic steroid therapy within 1 month before the surgery. 13. Patients who participating or participated in other clinical trial within 6 months. 14. Pregnancy or breastfeeding. 15. Any history of pelvic radiation. 16. Anticipated need for an ostomy at the time of operation. 17. Patients requiring urgent or emergent surgery. 18. Patients with prior or suspected diagnosis of inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or familial polyposis.

Outcomes

Primary Outcomes

Postoperative complications

The primary end point is major complication during surgery or within 90 days after surgery. A major intraoperative and postoperative complication is defined as a surgical or medical complication with a CTCAE grade of III or higher. The most severe complication in a patient was considered for the classification of the primary end point.

Time frame: up to 90 days after surgery

Secondary Outcomes

Conversion to laparoscopic or open surgery

One of the secondary outcome measures is the rate of conversion to laparoscopic or open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparoscopic port for the anastomosis, or a laparotomy wound for any part of the mesocolon dissection or the anastomosis.

Time frame: during the surgery

Concentration of c-reactive protein (CRP)

C-Reactive Protein (CRP) values on postoperative day 1and 3.

Time frame: 1 and 3 postoperative days

Concentration of procalcitonine (PCT)

Procalcitonine (PCT) values on postoperative day 1and 3.

Time frame: 1 and 3 postoperative days

Complete pathological assessment of CME specimens

Complete mesocolic excision (CME) is defined as complete resection of the mesocolon with its anatomical envelope. Rate of complete and near-CME achieved with hvNOTES, based on standard pathologic assessment of CME specimens.