Status:
UNKNOWN
Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
Lead Sponsor:
Renmin Hospital of Wuhan University
Conditions:
Colon Cancer
Natural Orifice Transluminal Endoscopic Surgery
Eligibility:
FEMALE
18-80 years
Phase:
NA
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, multicen...
Eligibility Criteria
Inclusion
- Female.
- 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 ≤ 5 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
- 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.
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04048421
Start Date
December 20 2019
End Date
November 30 2025
Last Update
August 3 2023
Active Locations (6)
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1
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100050
2
Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400042
3
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
4
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013