The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Surgical System C1000 had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal surgery. Recently, a new component of the system - the Patient Side Single Arm, is developed. It is an independent robotic arm designed for compatibility with the Sentire Surgical System, creating the hybrid surgical system known as the C1000 Ultra. The new component may enhance port placement flexibility, minimize arm collisions with the patient or operating table, and optimize docking for seamless integration into the operating room. The Patient Side Single Arm was proven by a preclinical study using cadaveric models to be safe and effective. The investigators would therefore like to conduct a prospective clinical study to evaluate the efficacy and safety of Sentire Surgical System Plus the Patient Side Single Arm in robotic colorectal surgery. The investigators believe that the results of this study will provide data to support its use for wide range of colorectal procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical applications for minimally invasive surgery with a cost-effective model.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery

Body mass index <35 kg/m2

Willingness to participate as demonstrated by giving informed consent

Disqualifiers

T4 tumor

Recurrent tumor

Extensive previous abdominal surgery precluding minimally invasive surgery

Contraindication to general anesthesia

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm

    Procedure/Surgery

    Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Robotic surgery using the Sentire Surgical System Plus Patient Side Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Conversion rate

The definition of a conversion for this study is an emergent or unplanned change in the treatment plan to conventional laparoscopic or open surgery.

Time frame
Up to 1 month
2

Perioperative complications

Perioperative 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. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.

Time frame
Up to 1 month

Secondary outcomes

1

Operative time

Time frame
Perioperative
2

Operative blood loss

Time frame
Perioperative
3

Pain scores on visual analog scale

Pain scores on visual analog scale range from 0 which implies no pain at all, to 100 which implies the worst pain imaginable.

Time frame
Up to 1 month
4

Analgesic requirement

Total doses of paracetamol and tramadol used postoperatively.

Time frame
Up to 1 month

Other outcomes

Sponsors and contacts

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