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

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ClinicalTrials.gov Identifier: NCT04048421
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Fu, Renmin Hospital of Wuhan University

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
Postoperative complications [ Time Frame: up to 90 days after surgery ]
Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded during and following each patient's hospital stay up to 90 days from surgery. The CCI is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death). Lower values represent better outcomes. These complications are defined and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Relapse-free survival [ Time Frame: 3 years after surgery ]
Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
Change History Complete list of historical versions of study NCT04048421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
  • Conversion to open surgery [ Time Frame: during the surgery ]
    One of the secondary outcome measures is the rate of conversion to open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparotomy wound for any part of the mesocolon dissection.
  • Concentration of c-reactive protein (CRP) [ Time Frame: 1 and 3 postoperative days ]
    C-Reactive Protein (CRP) values on postoperative day 1and 3.
  • Concentration of procalcitonine (PCT) [ Time Frame: 1 and 3 postoperative days ]
    Procalcitonine (PCT) values on postoperative day 1and 3.
  • Complete pathological assessment of CME specimens [ Time Frame: up to 1 week after surgery ]
    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.
  • Postoperative pain assessed by the numeric rating scale (NRS) [ Time Frame: up to 1 week after surgery ]
    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.
  • Amount of narcotic pain medication administered [ Time Frame: up to 1 week after surgery ]
    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).
  • Time to first flatus after surgery [ Time Frame: up to 1 week after surgery ]
    Time to first flatus is defined as days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery.
  • Number of harvested lymph nodes [ Time Frame: up to 1 week after surgery ]
    Number of harvested Lymph nodes according to the pathological report.
  • R0 resection [ Time Frame: up to 1 week after surgery ]
    Rate of resection without any affected margins during the surgical procedure according to the pathological report.
  • Length of hospital stay [ Time Frame: up to 4 weeks after surgery ]
    Days in the hospital after surgery.
  • Sexual function assessment [ Time Frame: baseline, 6 months, and 12 months after surgery ]
    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.
  • Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40) [ Time Frame: 14 days after surgery ]
    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.
  • Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ) [ Time Frame: 3, 6, and 12 months after surgery ]
    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.
  • 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 ]
    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.
  • Postoperative recurrence patterns [ Time Frame: 2 years after surgery ]
    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).
  • Relapse-free survival [ Time Frame: 2 years after surgery ]
    Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
  • Overall survival [ Time Frame: 2 years after surgery ]
    Overall survival is defined as time from surgery to death.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Conversion to open surgery [ Time Frame: during the surgery ]
    One of the secondary outcome measures is the rate of conversion to open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparotomy wound for any part of the mesocolon dissection.
  • C-Reactive Protein (CRP) [ Time Frame: 1, 2, and 3 postoperative days ]
    C-Reactive Protein (CRP) values on postoperative day 1, 2, and 3.
  • Procalcitonine (PCT) [ Time Frame: 1, 2, and 3 postoperative days ]
    Procalcitonine (PCT) values on postoperative day 1, 2, and 3.
  • Postoperative pain assessed by the numeric rating scale (NRS) [ Time Frame: up to 1 week after surgery ]
    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.
  • Amount of narcotic pain medication administered [ Time Frame: up to 1 week after surgery ]
    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).
  • Time to first flatus after surgery [ Time Frame: up to 1 week after surgery ]
    Time to first flatus is defined as days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery.
  • Complete mesocolic excision (CME) [ Time Frame: up to 1 week after surgery ]
    Complete mesocolic excision (CME) is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen.
  • Number of harvested lymph nodes [ Time Frame: up to 1 week after surgery ]
    Number of harvested Lymph nodes according to the pathological report.
  • R0 resection [ Time Frame: up to 1 week after surgery ]
    Rate of resection without any affected margins during the surgical procedure according to the pathological report.
  • Postoperative complications [ Time Frame: up to 90 days after surgery ]
    Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded during and following each patient's hospital stay up to 90 days from surgery. The CCI is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death). These complications are defined and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • Length of hospital stay [ Time Frame: up to 4 weeks after surgery ]
    Days in the hospital after surgery.
  • Sexual function assessment [ Time Frame: baseline, 6 months, and 12 months after surgery ]
    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.
  • Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40) [ Time Frame: 14 days after surgery ]
    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.
  • Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ) [ Time Frame: 3, 6, and 12 months after surgery ]
    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.
  • 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 ]
    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.
  • Postoperative recurrence patterns [ Time Frame: 3 years after surgery ]
    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).
  • Overall survival [ Time Frame: 3 years after surgery ]
    Overall survival is defined as time from surgery to death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 5, 2019)
Cost effectiveness of treatment [ Time Frame: 30 days after hospital discharge ]
Costs and cost effectiveness between these treatments in this patient population.
 
Descriptive Information
Brief Title  ICMJE Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
Official Title  ICMJE 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
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 100 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE Procedure: 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.
Study Arms  ICMJE Experimental: hvNOTES group
Participants will undergo hvNOTES radical colectomy.
Intervention: Procedure: hvNOTES radical colectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
200
Estimated Study Completion Date  ICMJE October 30, 2025
Estimated Primary Completion Date October 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≤ 3 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tao Fu, MD 86-88041911 ext 81333 tfu001@whu.edu.cn
Contact: Jun Ren, MD 86-88041911 ext 81332 renjun0414@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048421
Other Study ID Numbers  ICMJE vNOTESCA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tao Fu, Renmin Hospital of Wuhan University
Study Sponsor  ICMJE Renmin Hospital of Wuhan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tao Fu, MD Wuhan University Renmin Hospital
PRS Account Renmin Hospital of Wuhan University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP