Colorectal Neoplasms, ENT Diseases, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Nasopharyngeal Neoplasms, Oral Neoplasms, Oropharyngeal Neoplasms, Urologic Diseases, Urologic Neoplasms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERobotic single port surgery and NOTES
Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES 1. Body mass index \<35 kg/m2 2. Suitable for minimally invasive surgery 3. Willingness to participate as demonstrated by giving informed consent GENERAL
Exclusion criteria
FOR ALL PROCEDURES 1. Contraindication to general anesthesia 2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention 3. Untreated active infection 4. Noncorrectable coagulopathy 5. Presence of another malignancy or distant metastasis 6. Emergency surgery 7. Vulnerable population (e.g. mentally disabled, pregnancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | Up to 1 month | 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 |
| Perioperative complications | Up to 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss | Up to 1 month | — |
| Pain scores on a visual analog scale | Up to 1 month | — |
| Analgesic requirement | Up to 1 month | — |
| Length of hospital stay | Up to 1 month | — |
| Completeness of resection | Up to 1 month | Pathologic examination of the resected specimen for completeness of resection |
| Resection margins | Up to 1 month | Pathologic examination of the resected specimen for resection margins positivity |
| Number of lymph nodes harvested | Up to 1 month | Pathologic examination of the resected specimen (malignant cases) |
| Fecal incontinence quality of life after transanal surgery | Up to 1 year | After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL) |
| Urinary continence after radical prostatectomy | Up to 1 year | After radical prostatectomy; assessed by recording the number of pads used per day |
| Male sexual function after radical prostatectomy | Up to 1 year | After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF) |
| Renal function after nephrectomy | Up to 1 year | After nephrectomy; using renal function blood tests for urea and creatinine |
| Swallowing function after transoral robotic surgery (TORS) | Up to 1 year | After TORS; using the MD Anderson Dysphagia Inventory |
| Voice function after TORS | Up to 1 year | After TORS; using the Voice Handicap Index (VHI) 30 |
| Anal continence after transanal surgery | Up to 1 year | After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score) |
| Operative time | Intraoperative | — |
Countries
China
Outcome results
None listed