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

Colorectal Neoplasms Clinical Trial

Official title:

A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010813
• Other study ID #: CREC Ref. No.: 2016.348
• Status: Completed
• Phase: N/A
• First received: December 24, 2016
• Last updated: February 5, 2018
• Start date: December 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• ENT Diseases
• Hypopharyngeal Neoplasms
• Laryngeal Neoplasms
• Mouth Neoplasms
• Nasopharyngeal Neoplasms
• Neoplasms
• Oral Neoplasms
• Oropharyngeal Neoplasms
• Otorhinolaryngologic Diseases
• Urologic Diseases
• Urologic Neoplasms

Intervention

Procedure:
• Robotic single port surgery and NOTES
Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Operative time		Intraoperative
Secondary	Estimated blood loss		Up to 1 month
Secondary	Pain scores on a visual analog scale		Up to 1 month
Secondary	Analgesic requirement		Up to 1 month
Secondary	Length of hospital stay		Up to 1 month
Secondary	Completeness of resection	Pathologic examination of the resected specimen for completeness of resection	Up to 1 month
Secondary	Resection margins	Pathologic examination of the resected specimen for resection margins positivity	Up to 1 month
Secondary	Number of lymph nodes harvested	Pathologic examination of the resected specimen (malignant cases)	Up to 1 month
Secondary	Anal continence after transanal surgery	After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)	Up to 1 year
Secondary	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
Secondary	Urinary continence after radical prostatectomy	After radical prostatectomy; assessed by recording the number of pads used per day	Up to 1 year
Secondary	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
Secondary	Renal function after nephrectomy	After nephrectomy; using renal function blood tests for urea and creatinine	Up to 1 year
Secondary	Swallowing function after transoral robotic surgery (TORS)	After TORS; using the MD Anderson Dysphagia Inventory	Up to 1 year
Secondary	Voice function after TORS	After TORS; using the Voice Handicap Index (VHI) 30	Up to 1 year