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 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Procedure: hvNOTES radical colectomy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-randomized Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 30, 2024|
|Estimated Study Completion Date :||October 30, 2025|
Experimental: hvNOTES group
Participants will undergo hvNOTES radical colectomy.
Procedure: hvNOTES radical colectomy
With the patient under general anesthesia, pneumoperitoneum is achieved. Three trocars are inserted, one 12 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048421
|Contact: Tao Fu, MD||86-88041911 ext firstname.lastname@example.org|
|Contact: Jun Ren, MD||86-88041911 ext email@example.com|
|Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University|
|Wuhan, Hubei, China, 430060|
|Principal Investigator:||Tao Fu, MD||Wuhan University Renmin Hospital|