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This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.
Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.
Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.
Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.
Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.
Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel single port robotic system | Experimental | A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic single port surgery and NOTES | Procedure | Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery | Up to 1 month |
| Perioperative complications | Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Intraoperative | |
| Estimated blood loss | Up to 1 month | |
| Pain scores on a visual analog scale |
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GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES
GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31536129 | Derived | Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654. | |
| 31178203 |
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| Up to 1 month |
| Analgesic requirement | Up to 1 month |
| Length of hospital stay | Up to 1 month |
| Completeness of resection | Pathologic examination of the resected specimen for completeness of resection | Up to 1 month |
| Resection margins | Pathologic examination of the resected specimen for resection margins positivity | Up to 1 month |
| Number of lymph nodes harvested | Pathologic examination of the resected specimen (malignant cases) | Up to 1 month |
| Anal continence after transanal surgery | After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score) | Up to 1 year |
| Fecal incontinence quality of life after transanal surgery | After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL) | Up to 1 year |
| Urinary continence after radical prostatectomy | After radical prostatectomy; assessed by recording the number of pads used per day | Up to 1 year |
| Male sexual function after radical prostatectomy | After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF) | Up to 1 year |
| Renal function after nephrectomy | After nephrectomy; using renal function blood tests for urea and creatinine | Up to 1 year |
| Swallowing function after transoral robotic surgery (TORS) | After TORS; using the MD Anderson Dysphagia Inventory | Up to 1 year |
| Voice function after TORS | After TORS; using the Voice Handicap Index (VHI) 30 | Up to 1 year |
| Derived |
| Chan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D014571 | Urologic Neoplasms |
| D014570 | Urologic Diseases |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
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