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

  • End date
    Nov 30, 2025
  • participants needed
  • sponsor
    Renmin Hospital of Wuhan University
Updated on 4 October 2022
open surgery
adenocarcinoma of colon
transverse 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.

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


Yes No Not Sure

Inclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note