Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
NCT ID: NCT04048421
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
55 participants
INTERVENTIONAL
2019-12-20
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
NCT05911152
Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
NCT04843189
The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
NCT03470142
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
NCT06362902
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
NCT00164879
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
hvNOTES group
Participants will undergo hvNOTES radical colectomy.
hvNOTES radical colectomy
With the patient under general anesthesia, pneumoperitoneum is achieved. Three trocars are inserted, one 12 mm or 5 mm in the umbilicus and two 5 mm in the right and/or left flanks. Mobilization of the splenic flexure or the hepatic flexure is performed with an initial traditional laparoscopic approach. A single-port is inserted into the abdominal cavity transvaginally through the colpotomy. Then most of the procedures are performed transvaginally with conventional rigid laparoscopic instruments. The corresponding arteries and veins are divided. The mesocolon is mobilized. The small intestine/colon/rectum are then divided with stapler. The specimen is removed transvaginally. Intracorporeal anastomosis is performed as per the surgeon's standard of care. For sigmoidectomy, the colon is then exteriorized and the anvil is fixed in the colon. An end-to-end anastomosis is performed using a circular stapler. Drainage tubes may be used.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hvNOTES radical colectomy
With the patient under general anesthesia, pneumoperitoneum is achieved. Three trocars are inserted, one 12 mm or 5 mm in the umbilicus and two 5 mm in the right and/or left flanks. Mobilization of the splenic flexure or the hepatic flexure is performed with an initial traditional laparoscopic approach. A single-port is inserted into the abdominal cavity transvaginally through the colpotomy. Then most of the procedures are performed transvaginally with conventional rigid laparoscopic instruments. The corresponding arteries and veins are divided. The mesocolon is mobilized. The small intestine/colon/rectum are then divided with stapler. The specimen is removed transvaginally. Intracorporeal anastomosis is performed as per the surgeon's standard of care. For sigmoidectomy, the colon is then exteriorized and the anvil is fixed in the colon. An end-to-end anastomosis is performed using a circular stapler. Drainage tubes may be used.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Renmin Hospital of Wuhan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tao Fu
Chief of Department of Gastrointestinal Surgery II
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tao Fu, MD
Role: PRINCIPAL_INVESTIGATOR
Wuhan University Renmin Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. doi: 10.1007/s00464-005-3006-0. No abstract available.
Rattner DW, Hawes R, Schwaitzberg S, Kochman M, Swanstrom L. The Second SAGES/ASGE White Paper on natural orifice transluminal endoscopic surgery: 5 years of progress. Surg Endosc. 2011 Aug;25(8):2441-8. doi: 10.1007/s00464-011-1605-5. Epub 2011 Feb 27. No abstract available.
Moloney JM, Gan PS. Hybrid Transvaginal NOTES and Mini-Laparoscopic Colectomy: Benefit Through Synergy. JSLS. 2016 Oct-Dec;20(4):e2016.00062. doi: 10.4293/JSLS.2016.00062.
Lamm SH, Zerz A, Efeoglou A, Steinemann DC. Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy for Diverticular Disease: A Prospective Cohort Study. J Am Coll Surg. 2015 Oct;221(4):789-97. doi: 10.1016/j.jamcollsurg.2015.07.012. Epub 2015 Jul 21.
Bulian DR, Runkel N, Burghardt J, Lamade W, Butters M, Utech M, Thon KP, Lefering R, Heiss MM, Buhr HJ, Lehmann KS. Natural Orifice Transluminal Endoscopic Surgery (NOTES) for colon resections--analysis of the first 139 patients of the German NOTES Registry (GNR). Int J Colorectal Dis. 2014 Jul;29(7):853-61. doi: 10.1007/s00384-014-1883-1. Epub 2014 May 7.
D'Hondt M, Devriendt D, Van Rooy F, Vansteenkiste F, Dozois E. Transvaginal pure NOTES sigmoid resection using a single port device. Tech Coloproctol. 2014 Jan;18(1):77-80. doi: 10.1007/s10151-013-1005-z. Epub 2013 Apr 6.
Alba Mesa F, Amaya Cortijo A, Romero Fernandez JM, Komorowski AL, Sanchez Hurtado MA, Fernandez Ortega E, Sanchez Margallo FM. Transvaginal sigmoid cancer resection: first case with 12 months of follow-up--technique description. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):587-90. doi: 10.1089/lap.2011.0469. Epub 2012 Jun 12.
Alba Mesa F, Amaya Cortijo A, Romero Fernandez JM, Komorowski AL, Sanchez Hurtado MA, Sanchez Margallo FM. Totally transvaginal resection of the descending colon in an experimental model. Surg Endosc. 2012 Mar;26(3):877-81. doi: 10.1007/s00464-011-1919-3. Epub 2011 Sep 23.
Lacy AM, Delgado S, Rojas OA, Almenara R, Blasi A, Llach J. MA-NOS radical sigmoidectomy: report of a transvaginal resection in the human. Surg Endosc. 2008 Jul;22(7):1717-23. doi: 10.1007/s00464-008-9956-2. Epub 2008 May 7.
Sodergren MH, Clark J, Athanasiou T, Teare J, Yang GZ, Darzi A. Natural orifice translumenal endoscopic surgery: critical appraisal of applications in clinical practice. Surg Endosc. 2009 Apr;23(4):680-7. doi: 10.1007/s00464-008-0278-1. Epub 2009 Jan 1.
Whiteford MH, Spaun GO. A colorectal surgeons viewpoint on natural orifice translumenal endoscopic surgery. Minerva Chir. 2008 Oct;63(5):385-8.
Park JS, Choi GS, Lim KH, Jang YS, Kim HJ, Park SY, Jun SH. Clinical outcome of laparoscopic right hemicolectomy with transvaginal resection, anastomosis, and retrieval of specimen. Dis Colon Rectum. 2010 Nov;53(11):1473-9. doi: 10.1007/DCR.0b013e3181f1cc17.
Alba Mesa F, Sanchez Hurtado MA, Sanchez Margallo FM, Romero Fernandez JM, Amaya Cortijo A, Fernandez Ortega E, Komorowski AL. Laparoscopy-assisted transvaginal resection of sigmoid cancer. Eur J Surg Oncol. 2014 Jun;40(6):713-8. doi: 10.1016/j.ejso.2014.01.008. Epub 2014 Feb 7.
Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.
Fu T, Ren J, Yao H, Huang B, Sun L, Li X, Tong W. Feasibility and safety of hybrid transvaginal natural orifice transluminal endoscopic surgery for colon cancer: Protocol for a multicenter, single-arm, phase II trial (vNOTESCA). Heliyon. 2023 Sep 23;9(10):e20187. doi: 10.1016/j.heliyon.2023.e20187. eCollection 2023 Oct.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
vNOTESCA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.