Back to resultsFeasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
Primary Purpose
Colon Cancer, Natural Orifice Transluminal Endoscopic Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hvNOTES radical colectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 ≤ 3 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 Criteria:
- 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.
Sites / Locations
- Beijing Friendship Hospital of Capital Medical UniversityRecruiting
- Daping Hospital of Army Medical UniversityRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- The Third Xiangya Hospital of Central South University
- Qingdao Municipal HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hvNOTES group
Arm Description
Participants will undergo hvNOTES radical colectomy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Concentration of c-reactive protein (CRP)
C-Reactive Protein (CRP) values on postoperative day 1and 3.
Concentration of procalcitonine (PCT)
Procalcitonine (PCT) values on postoperative day 1and 3.
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.
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.
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).
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.
Number of harvested lymph nodes
Number of harvested Lymph nodes according to the pathological report.
R0 resection
Rate of resection without any affected margins during the surgical procedure according to the pathological report.
Length of hospital stay
Days in the hospital 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.
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.
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.
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.
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).
Relapse-free survival
Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
Overall survival
Overall survival is defined as time from surgery to death.
Full Information
NCT ID
NCT04048421
First Posted
July 3, 2019
Last Updated
August 1, 2023
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04048421
Brief Title
Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Natural Orifice Transluminal Endoscopic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hvNOTES group
Arm Type
Experimental
Arm Description
Participants will undergo hvNOTES radical colectomy.
Intervention Type
Procedure
Intervention Name(s)
hvNOTES radical colectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
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.
Time Frame
up to 90 days after surgery
Secondary Outcome Measure Information:
Title
Conversion to laparoscopic or open surgery
Description
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.
Time Frame
during the surgery
Title
Concentration of c-reactive protein (CRP)
Description
C-Reactive Protein (CRP) values on postoperative day 1and 3.
Time Frame
1 and 3 postoperative days
Title
Concentration of procalcitonine (PCT)
Description
Procalcitonine (PCT) values on postoperative day 1and 3.
Time Frame
1 and 3 postoperative days
Title
Complete pathological assessment of CME specimens
Description
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.
Time Frame
up to 1 week after surgery
Title
Postoperative pain assessed by the numeric rating scale (NRS)
Description
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.
Time Frame
up to 1 week after surgery
Title
Amount of narcotic pain medication administered
Description
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 Frame
up to 1 week after surgery
Title
Time to first flatus after surgery
Description
Time to first flatus is defined as days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery.
Time Frame
up to 1 week after surgery
Title
Number of harvested lymph nodes
Description
Number of harvested Lymph nodes according to the pathological report.
Time Frame
up to 1 week after surgery
Title
R0 resection
Description
Rate of resection without any affected margins during the surgical procedure according to the pathological report.
Time Frame
up to 1 week after surgery
Title
Length of hospital stay
Description
Days in the hospital after surgery.
Time Frame
up to 4 weeks after surgery
Title
Sexual function assessment
Description
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.
Time Frame
baseline, 6 months, and 12 months after surgery
Title
Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)
Description
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.
Time Frame
14 days after surgery
Title
Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)
Description
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.
Time Frame
3, 6, and 12 months after surgery
Title
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Description
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.
Time Frame
baseline, 3 and 12 months after surgery
Title
Postoperative recurrence patterns
Description
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).
Time Frame
2 years after surgery
Title
Relapse-free survival
Description
Relapse-free survival is defined as the time from random assignment until disease relapse or death from any cause.
Time Frame
2 years after surgery
Title
Overall survival
Description
Overall survival is defined as time from surgery to death.
Time Frame
2 years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Fu, MD
Phone
86-88041911
Ext
81333
Email
tfu001@whu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ren, MD
Phone
86-88041911
Ext
81332
Email
renjun0414@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Fu, MD
Organizational Affiliation
Wuhan University Renmin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Yao, MD
Email
yaohongwei@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Hongwei Yao, MD
Facility Name
Daping Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, MD
Email
vdtong@163.com
First Name & Middle Initial & Last Name & Degree
Weidong Tong, MD
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD
Phone
8615902761670
Email
renjun0414@163.com
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong Li, MD
Email
lixiaorong@medmail.com.cn
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Fu, MD
Phone
8613720120190
Email
futao1975@tom.com
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lifeng Sun, MD
Phone
8613958103041
Email
sunlifeng@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Lifeng Sun, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
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Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer
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