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

STATUS

Recruiting
End date

Nov 30, 2025
participants needed

55
sponsor

Renmin Hospital of Wuhan University

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Updated on 4 October 2022

See if I qualify

open surgery

colectomy

metastasis

adenocarcinoma

adenocarcinoma of colon

hemicolectomy

transverse colon cancer

Summary

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.

Details

Condition	Colon Cancer, Natural Orifice Transluminal Endoscopic Surgery
Treatment	hvNOTES radical colectomy
Clinical Study Identifier	NCT04048421
Sponsor	Renmin Hospital of Wuhan University
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 ≤ 3 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
Exclusion Criteria
	Patients who have never experienced complete sexual intercourse before the operation
	Previous intestinal surgery with any cause
	cT4 tumor
	Complications of colon cancer (bleeding, obstruction, or perforation)
	Previous neoadjuvant chemotherapy or radiotherapy for colon cancer
	Patients who are diagnosed with other malignancies within 5 years
	Vulnerable patients
	Vaginal stenosis
	Prior reconstructive surgery of the vagina not including hysterectomy
	Unstable angina or myocardial infarction within the past 6 months
	Cerebrovascular accident within the past 6 months
	Continuous systemic steroid therapy within 1 month before the surgery
	Patients who participating or participated in other clinical trial within 6 months
	Pregnancy or breastfeeding
	Any history of pelvic radiation
	Anticipated need for an ostomy at the time of operation
	Patients requiring urgent or emergent surgery
	Patients with prior or suspected diagnosis of inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or familial polyposis

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