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

NCT04048421 | Unknown

• 1 other identifier: vNOTESCA
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

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.

Conditions

Colon Cancer; Natural Orifice Transluminal Endoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  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.

  up to 90 days after surgery

Secondary Outcomes (17)

• Conversion to laparoscopic or open surgery

  during the surgery

• Concentration of c-reactive protein (CRP)

  1 and 3 postoperative days

• Concentration of procalcitonine (PCT)

  1 and 3 postoperative days

• Complete pathological assessment of CME specimens

  up to 1 week after surgery

• Postoperative pain assessed by the numeric rating scale (NRS)

  up to 1 week after surgery

Study Arms (1)

hvNOTES group

EXPERIMENTAL

Participants will undergo hvNOTES radical colectomy.

Procedure: hvNOTES radical colectomy

Interventions

hvNOTES radical colectomy PROCEDURE

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.

hvNOTES group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (6)

Beijing Friendship Hospital of Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 313000, China

RECRUITING

Related Publications (15)

• 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.

  PMID: 16402290 BACKGROUND

• 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.

  PMID: 21359881 BACKGROUND

• 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.

  PMID: 27904307 BACKGROUND

• 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.

  PMID: 26282488 BACKGROUND

• 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.

  PMID: 24798629 BACKGROUND

• 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.

  PMID: 23564271 BACKGROUND

• 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.

  PMID: 22690651 BACKGROUND

• 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.

  PMID: 21947741 BACKGROUND

• 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.

  PMID: 18461385 BACKGROUND

• 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.

  PMID: 19118425 BACKGROUND

• Whiteford MH, Spaun GO. A colorectal surgeons viewpoint on natural orifice translumenal endoscopic surgery. Minerva Chir. 2008 Oct;63(5):385-8.

  PMID: 18923349 BACKGROUND

• 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.

  PMID: 20940594 BACKGROUND

• 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.

  PMID: 24560464 BACKGROUND

• 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.

  PMID: 22648123 BACKGROUND

• 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.

  PMID: 37780770 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Tao Fu, MD

  Wuhan University Renmin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Fu, MD

CONTACT

86-88041911; tfu001@whu.edu.cn

Jun Ren, MD

CONTACT

86-88041911; renjun0414@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Gastrointestinal Surgery II

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: August 7, 2019
• Study Start: December 20, 2019
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tfu001@whu.edu.cn.

Locations

CN (6)