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
Updated on 4 October 2022
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 IdentifierNCT04048421
SponsorRenmin Hospital of Wuhan University
Last Modified on4 October 2022

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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