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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 w
Sponsor: Chinese University of Hong Kong

Current Primary Outcome:

  • Conversion rate [ Time Frame: 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 [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: December 24, 2016
Date Started: December 2016
Date Completion: June 2017
Last Updated: January 3, 2017
Last Verified: January 2017