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

Not Applicable

Recruiting

• Conditions: Natural Orifice Transluminal Endoscopic Surgery; Colon Cancer
• Interventions: Procedure: hvNOTES radical colectomy

• Registration Number: NCT04048421
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-07
• Study Start: 2019-12-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hvNOTES group	hvNOTES radical colectomy	Participants will undergo hvNOTES radical colectomy.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	up to 90 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Time to first flatus after surgery	up to 1 week after surgery	Time to first flatus is defined as days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery.
Length of hospital stay	up to 4 weeks after surgery	Days in the hospital after surgery.
Postoperative pain assessed by the numeric rating scale (NRS)	up to 1 week after surgery	Pain score assessments: The investigator's staff will provide a rating scale to the patients to self-rate and record their pain at baseline (prior to surgery), at 24, 48, 72, 96, 120, 144, and 168 hours following the procedure end time (or discharge if earlier) postoperatively using the numeric rating scale (NRS) where 0 is for no pain and 10 is for the worst pain imaginable.
Number of harvested lymph nodes	up to 1 week after surgery	Number of harvested Lymph nodes according to the pathological report.
Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)	14 days after surgery	Patient's quality of recovery is assessed by using the Quality of Recovery 40 questionnaire (QoR-40, score range: 40-200). Higher values represent better outcomes. The validate questionnaire measure quality of recovery by evaluating patients' comfort, emotions, physical independence, and support using the same scale.
Concentration of procalcitonine (PCT)	1 and 3 postoperative days	Procalcitonine (PCT) values on postoperative day 1and 3.
R0 resection	up to 1 week after surgery	Rate of resection without any affected margins during the surgical procedure according to the pathological report.
Conversion to laparoscopic or open surgery	during the 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.
Concentration of c-reactive protein (CRP)	1 and 3 postoperative days	C-Reactive Protein (CRP) values on postoperative day 1and 3.
Amount of narcotic pain medication administered	up to 1 week after surgery	The amount of narcotic pain medication administered through postoperative day 7 (or discharge if earlier) will be recorded (total dose of morphine equivalent during hospitalization and average dose per day).
Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)	3, 6, and 12 months after surgery	Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ, score range: 28-102) will be administered to assess the patient's perception of scarring. Lower values represent better outcomes. The PSAQ consists of 5 subscales: Appearance, symptoms, consciousness, satisfaction with appearance, and satisfaction with symptoms.
Complete pathological assessment of CME specimens	up to 1 week after surgery	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.
Sexual function assessment	baseline, 6 months, and 12 months after surgery	Patient self-reported sexual functions as assessed by the Female Sexual Function Index (FSFI). The FSFI is a 19-item questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function.
Overall survival	2 years after surgery	Overall survival is defined as time from surgery to death.
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	baseline, 3 and 12 months after surgery	Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure. This scale has functional, global health, and symptoms subscales/items all scored from 0 to 100. Higher scores on these subscales indicate high level of functioning, high quality of life, and high level of symptomatology, respectively.
Relapse-free survival	2 years after surgery	Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
Postoperative recurrence patterns	2 years after surgery	The recurrence patterns are determined according to the primary recurrence site diagnosed radiologically (CT, US, MRI, or PET-CT), or with histologic proof (ascitic cytology, colonoscopic biopsy, or surgery).

Trial Locations

Locations (6)

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, Shandong, China

Daping Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Beijing Friendship Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China