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

Launched by RENMIN HOSPITAL OF WUHAN UNIVERSITY · Aug 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical method called hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES) for women with colon cancer. The goal is to see if this procedure is safe and effective for removing part of the colon. The study will involve 55 women aged 18 to 80 who have specific types of colon tumors that are not too large or advanced. Eligible participants must be in good overall health, have a certain body weight, and not have had previous major surgeries or certain medical conditions.

If you decide to participate, you will undergo this innovative surgery performed by experienced surgeons. Throughout the study, your health will be closely monitored, including your recovery, any complications, and how well the surgery works in the long run. This trial aims to gather important information about the safety and effectiveness of this new surgical approach, which could help improve treatment options for women with colon cancer in the future.

Gender

FEMALE

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.