Evaluating a new surgical approach for colon cancer using hybrid transvaginal techniques
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
NA · Renmin Hospital of Wuhan University · NCT04048421
This study is testing a new surgical method for removing colon cancer in women to see if it is safe and helps them recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Renmin Hospital of Wuhan University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Beijing, Beijing and 5 other locations) |
| Trial ID | NCT04048421 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES) for radical colectomy in patients with resectable colon cancer. It is a prospective, single-arm, multicenter, uncontrolled study involving 55 eligible female subjects aged 18 to 80. Experienced surgeons will perform the hvNOTES procedure, and various postoperative outcomes such as complications, recovery, and survival rates will be recorded and analyzed. The goal is to validate the safety and functional outcomes of this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 80 with resectable colonic adenocarcinoma and specific tumor characteristics.
Not a fit: Patients with advanced local disease, distant metastasis, or transverse colon cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgery options for colon cancer patients, potentially improving recovery times and outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in minimally invasive techniques for colorectal surgery, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 5 other locations
- Beijing Friendship Hospital of Capital Medical University — Beijing, Beijing, China (RECRUITING)
- Daping Hospital of Army Medical University — Chongqing, Chongqing, China (RECRUITING)
- Renmin Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
- Qingdao Municipal Hospital — Qingdao, Shandong, China (RECRUITING)
- The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Tao Fu, MD — Wuhan University Renmin Hospital
- Study coordinator: Tao Fu, MD
- Email: tfu001@whu.edu.cn
- Phone: 86-88041911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Cancer, Natural Orifice Transluminal Endoscopic Surgery