Colon CancerNCT04048421
Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
A study testing hvNOTES radical colectomy in people with Colon Cancer and Natural Orifice Transluminal Endoscopic Surgery, run by Renmin Hospital of Wuhan University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Colon Cancer, Natural Orifice Transluminal Endoscopic Surgery
- What is being tested?
- hvNOTES radical colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 6 sitesChina
- Study dates
- 20 Dec 2019to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 22Show fewer
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, 100050
Hongwei Yao, MD, yaohongwei@medmail.com.cn
Hongwei Yao, MD
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xiaorong Li, MD, lixiaorong@medmail.com.cn
- Recruiting
Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400042
Weidong Tong, MD, vdtong@163.com
Weidong Tong, MD
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 313000
Lifeng Sun, MD, 8613958103041, sunlifeng@zju.edu.cn
Lifeng Sun, MD
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Tao Fu, MD, 8613720120190, futao1975@tom.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Jun Ren, MD, 8615902761670, renjun0414@163.com
About this study
Official title: 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
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.
- Being tested
- hvNOTES radical colectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hvNOTES radical colectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| hvNOTES group | Experimental | Participants will undergo hvNOTES radical colectomy. Receives: Procedure: hvNOTES radical colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 90 days after surgery
Secondary outcomes (17)
Conversion to laparoscopic or open surgery
One of the secondary outcome measures is the rate of conversion to laparoscopic or open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparoscopic port for the anastomosis, or a laparotomy wound for any part of the mesocolon dissection or the anastomosis.
Measured: during the surgery
Concentration of c-reactive protein (CRP)
C-Reactive Protein (CRP) values on postoperative day 1and 3.
Measured: 1 and 3 postoperative days
Concentration of procalcitonine (PCT)
Procalcitonine (PCT) values on postoperative day 1and 3.
Measured: 1 and 3 postoperative days
Complete pathological assessment of CME specimens
Complete mesocolic excision (CME) is defined as complete resection of the mesocolon with its anatomical envelope. Rate of complete and near-CME achieved with hvNOTES, based on standard pathologic assessment of CME specimens.
Measured: up to 1 week after surgery
Postoperative pain assessed by the numeric rating scale (NRS)
Pain score assessments: The investigator's staff will provide a rating scale to the patients to self-rate and record their pain at baseline (prior to surgery), at 24, 48, 72, 96, 120, 144, and 168 hours following the procedure end time (or discharge if earlier) postoperatively using the numeric rating scale (NRS) where 0 is for no pain and 10 is for the worst pain imaginable.
Measured: up to 1 week after surgery
Amount of narcotic pain medication administered
The amount of narcotic pain medication administered through postoperative day 7 (or discharge if earlier) will be recorded (total dose of morphine equivalent during hospitalization and average dose per day).
Measured: up to 1 week after surgery
Time to first flatus after surgery
Time to first flatus is defined as days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery.
Measured: up to 1 week after surgery
Number of harvested lymph nodes
Number of harvested Lymph nodes according to the pathological report.
Measured: up to 1 week after surgery
R0 resection
Rate of resection without any affected margins during the surgical procedure according to the pathological report.
Measured: up to 1 week after surgery
Length of hospital stay
Days in the hospital after surgery.
Measured: up to 4 weeks after surgery
Sexual function assessment
Patient self-reported sexual functions as assessed by the Female Sexual Function Index (FSFI). The FSFI is a 19-item questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function.
Measured: baseline, 6 months, and 12 months after surgery
Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)
Patient's quality of recovery is assessed by using the Quality of Recovery 40 questionnaire (QoR-40, score range: 40-200). Higher values represent better outcomes. The validate questionnaire measure quality of recovery by evaluating patients' comfort, emotions, physical independence, and support using the same scale.
Measured: 14 days after surgery
Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)
Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ, score range: 28-102) will be administered to assess the patient's perception of scarring. Lower values represent better outcomes. The PSAQ consists of 5 subscales: Appearance, symptoms, consciousness, satisfaction with appearance, and satisfaction with symptoms.
Measured: 3, 6, and 12 months after surgery
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure. This scale has functional, global health, and symptoms subscales/items all scored from 0 to 100. Higher scores on these subscales indicate high level of functioning, high quality of life, and high level of symptomatology, respectively.
Measured: baseline, 3 and 12 months after surgery
Postoperative recurrence patterns
The recurrence patterns are determined according to the primary recurrence site diagnosed radiologically (CT, US, MRI, or PET-CT), or with histologic proof (ascitic cytology, colonoscopic biopsy, or surgery).
Measured: 2 years after surgery
Relapse-free survival
Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
Measured: 2 years after surgery
Overall survival
Overall survival is defined as time from surgery to death.
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start20 Dec 2019
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Fu, Renmin Hospital of Wuhan University
- Investigators
- Tao Fu, MD, Principal investigator, Wuhan University Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048421
- Sponsor's protocol ID
- vNOTESCA
- Status last verified
- Aug 2023
- First submitted
- 3 Jul 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in natural orifice transluminal endoscopic surgery. Data or samples shared will be coded, with no protected health information (PHI) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
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.
PubMed 16402290Rattner 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.
PubMed 21359881Moloney 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.
PubMed 27904307Lamm 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.
PubMed 26282488Bulian 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.
PubMed 24798629D'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.
PubMed 23564271Alba 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.
PubMed 22690651Alba 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.
PubMed 21947741Lacy 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.
PubMed 18461385Sodergren 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.
PubMed 19118425Whiteford MH, Spaun GO. A colorectal surgeons viewpoint on natural orifice translumenal endoscopic surgery. Minerva Chir. 2008 Oct;63(5):385-8.
PubMed 18923349Park 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.
PubMed 20940594Alba 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.
PubMed 24560464Noguera 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.
PubMed 22648123Fu 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.
PubMed 37780770
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04048421
- Acronym / sponsor ID
- vNOTESCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hvNOTES group | Experimental | Procedure: hvNOTES radical colectomyParticipants will undergo hvNOTES radical colectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hvNOTES radical colectomyWith 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. | Procedure or surgery | hvNOTES group |
Primary outcome
Postoperative complications
Time frame: up to 90 days after surgery
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.
17 secondary outcomes
Conversion to laparoscopic or open surgery
Time frame: during the surgery
Concentration of c-reactive protein (CRP)
Time frame: 1 and 3 postoperative days
Concentration of procalcitonine (PCT)
Time frame: 1 and 3 postoperative days
Complete pathological assessment of CME specimens
Time frame: up to 1 week after surgery
Postoperative pain assessed by the numeric rating scale (NRS)
Time frame: up to 1 week after surgery
Amount of narcotic pain medication administered
Time frame: up to 1 week after surgery
Time to first flatus after surgery
Time frame: up to 1 week after surgery
Number of harvested lymph nodes
Time frame: up to 1 week after surgery
R0 resection
Time frame: up to 1 week after surgery
Length of hospital stay
Time frame: up to 4 weeks after surgery
Sexual function assessment
Time frame: baseline, 6 months, and 12 months after surgery
Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)
Time frame: 14 days after surgery
Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)
Time frame: 3, 6, and 12 months after surgery
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: baseline, 3 and 12 months after surgery
Postoperative recurrence patterns
Time frame: 2 years after surgery
Relapse-free survival
Time frame: 2 years after surgery
Overall survival
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 16402290Rattner 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.
- Background: PubMed 21359881Rattner 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.
- Background: PubMed 27904307Moloney 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.
- Background: PubMed 26282488Lamm 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.
- Background: PubMed 24798629Bulian 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.
- Background: PubMed 23564271D'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.
- Background: PubMed 22690651Alba 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.
- Background: PubMed 21947741Alba 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.
- Background: PubMed 18461385Lacy 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.
- Background: PubMed 19118425Sodergren 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.
- Background: PubMed 18923349Whiteford MH, Spaun GO. A colorectal surgeons viewpoint on natural orifice translumenal endoscopic surgery. Minerva Chir. 2008 Oct;63(5):385-8.
- Background: PubMed 20940594Park 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.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in natural orifice transluminal endoscopic surgery. Data or samples shared will be coded, with no protected health information (PHI) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Fu, MD principal investigator
Wuhan University Renmin Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hvNOTES radical colectomy in people with Colon Cancer and Natural Orifice Transluminal Endoscopic Surgery, run by Renmin Hospital of Wuhan University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Fu, MD (86-88041911 ext. 81333, tfu001@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048421, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.