NCT03010813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

December 24, 2016

Last Update Submit

February 5, 2018

Conditions

Colorectal NeoplasmsUrologic NeoplasmsUrologic DiseasesNasopharyngeal NeoplasmsOropharyngeal NeoplasmsOral NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsENT Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (1)

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

Procedure: Robotic single port surgery and NOTES

Interventions

Robotic single port surgery and NOTESPROCEDURE

Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery

Novel single port robotic system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \<35 kg/m2
  • Suitable for minimally invasive surgery
  • Willingness to participate as demonstrated by giving informed consent

You may not qualify if:

  • Contraindication to general anesthesia
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Noncorrectable coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

  • 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.

    PMID: 31536129DERIVED

  • 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.

    PMID: 31178203DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsUrologic NeoplasmsUrologic DiseasesNasopharyngeal NeoplasmsOropharyngeal NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesMouth DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 24, 2016

First Posted

January 5, 2017

Study Start

December 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)