Clinical trial NCT03010813: A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery
Official title: A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Urologic Neoplasms
Urologic Diseases
Nasopharyngeal Neoplasms
Oropharyngeal Neoplasms
Oral Neoplasms
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
ENT Diseases
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Conversion rate
timeFrame: Up to 1 month
measure: Perioperative complications
timeFrame: Up to 1 month
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Up to 1 month
measure: Pain scores on a visual analog scale
timeFrame: Up to 1 month
measure: Analgesic requirement
timeFrame: Up to 1 month
measure: Length of hospital stay
timeFrame: Up to 1 month
measure: Completeness of resection
timeFrame: Up to 1 month
measure: Resection margins
timeFrame: Up to 1 month
measure: Number of lymph nodes harvested
timeFrame: Up to 1 month
measure: Anal continence after transanal surgery
timeFrame: Up to 1 year
measure: Fecal incontinence quality of life after transanal surgery
timeFrame: Up to 1 year
measure: Urinary continence after radical prostatectomy
timeFrame: Up to 1 year
measure: Male sexual function after radical prostatectomy
timeFrame: Up to 1 year
measure: Renal function after nephrectomy
timeFrame: Up to 1 year
measure: Swallowing function after transoral robotic surgery (TORS)
timeFrame: Up to 1 year
measure: Voice function after TORS
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
References:
citation: 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.
citation: 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.