A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery

Not Applicable

Completed

• Conditions: Nasopharyngeal Neoplasms; ENT Diseases; Laryngeal Neoplasms; Colorectal Neoplasms; Oropharyngeal Neoplasms; Urologic Neoplasms; Hypopharyngeal Neoplasms; Urologic Diseases; Oral Neoplasms
• Interventions: Procedure: Robotic single port surgery and NOTES

• Registration Number: NCT03010813
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel single port robotic system	Robotic single port surgery and NOTES	A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Operative time	Intraoperative
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)
Anal continence after transanal surgery	Up to 1 year	After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)
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

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China