Clinical trial NCT04048421: Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Natural Orifice Transluminal Endoscopic Surgery
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: Conversion to laparoscopic or open surgery
timeFrame: during the surgery
measure: Concentration of c-reactive protein (CRP)
timeFrame: 1 and 3 postoperative days
measure: Concentration of procalcitonine (PCT)
timeFrame: 1 and 3 postoperative days
measure: Complete pathological assessment of CME specimens
timeFrame: up to 1 week after surgery
measure: Postoperative pain assessed by the numeric rating scale (NRS)
timeFrame: up to 1 week after surgery
measure: Amount of narcotic pain medication administered
timeFrame: up to 1 week after surgery
measure: Time to first flatus after surgery
timeFrame: up to 1 week after surgery
measure: Number of harvested lymph nodes
timeFrame: up to 1 week after surgery
measure: R0 resection
timeFrame: up to 1 week after surgery
measure: Length of hospital stay
timeFrame: up to 4 weeks after surgery
measure: Sexual function assessment
timeFrame: baseline, 6 months, and 12 months after surgery
measure: Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)
timeFrame: 14 days after surgery
measure: Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)
timeFrame: 3, 6, and 12 months after surgery
measure: Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
timeFrame: baseline, 3 and 12 months after surgery
measure: Postoperative recurrence patterns
timeFrame: 2 years after surgery
measure: Relapse-free survival
timeFrame: 2 years after surgery
measure: Overall survival
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital of Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital of Army Medical University
state: Chongqing
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Wuhan University Renmin Hospital
name: Tao Fu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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