First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study

Design

This sequentially reported prospective single-institution, single-surgeon study was conducted from 18 May 2021 to 27 July 2021 at Gleneagles Hospital Hong Kong. Institutional Review Board ethical approval was obtained on 17 May 2021. All consecutive patients listed for MIS gynecological surgery by the principal investigator/surgeon fulfilling the study criteria were invited to participate in the study. The trial is registered at ClinicalTrials.gov.

The following baseline patient characteristics were recorded: age, diagnosis, name of surgery and date of surgery. On discharge from hospital, the following data were collected: date of admission, date of discharge, duration of surgery, blood loss, the successful completion of the procedure with the Sirius System without conversion to another camera system, intraoperative and postoperative complications. These data were extracted from the hospital database by the principal investigator/surgeon, and entered into a laptop computer protected by a password accessible only to the principal investigator/surgeon.

Each nurse assisting the procedure and operating the Sirius Endoscope completed a Usability Questionnaire of the Sirius Endoscope System with a 1–5 Likert scale for each question (1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; 5=strongly agree), and entered free-text comments (online supplemental material 1). Anonymized video data of the surgical procedure were captured for analysis and validation. The recording were only of the surgical field, and only during the surgical procedure to prevent capturing any personal identifiable details. The video was reviewed for assessing the stability and safety of the procedure, and whether there were any modifications or unexpected changes to the procedure due to the Sirius System. The surgeon’s comments on the efficacy, usability and safety of the Sirius System compared with a conventional laparoscope were recorded. Modifications and improvements to the Sirius System by Precision Robotics, based on feedback from the camera operators and surgeon during the course of the study, were recorded.

Participants

All consecutive patients aged 18–70 years listed for gynecological laparoscopic surgery by the principal investigator/surgeon during the duration of the study were invited to participate. An information sheet and consent for the study was available for the patient, and an informed consent was taken by the surgeon. It was emphasized that participation in the study was voluntary, and if they did not consent to the study, it would not affect their subsequent treatment and management. The participants were aware that this was an evaluation of a new endoscope. The safety aspects of the study including the availability of a conventional endoscope for immediate conversion if necessary was emphasized.

Exclusion criteria were pregnancy and/or failure to provide written informed consent for the study.

Setting

The study was conducted in Gleneagles Hospital Hong Kong, a multispecialty hospital. Prior to the commencement of the clinical trial, a comprehensive training program for the operating theater nurses on the usage of the Sirius System was conducted by Precision Robotics, and the Gleneagles Hospital Hong Kong Nurse Educator. This involved didactic as well as video and hands-on simulator training from 23 February 2021 to 19 March 2021.

A competency assessment was held from 20 March 2021 to 12 April 2021. This involved an online knowledge assessment, followed by assessment using a competency checklist on the usage of the Sirius System, as well as a simulation assessment on the simulator. In total 63 nurses were trained, and assessed to be competent before commencement of the clinical trial (online supplemental material 2).

The nine nurse assistants involved in this initial study had an average of 10.5 years (range: 5–15 years) of experience in assisting in laparoscopic surgeries. They had all completed the comprehensive training program on the usage of the Sirius System conducted by Precision Robotics and the Gleneagles Hospital Hong Kong Nurse Educator. Subsequently, the video recording of each procedure was reviewed, to ensure that the level of competence expected of the camera operators were achieved, and maintained throughout the study.

The surgeon/principal investigator is an experienced, advanced gynecological laparoscopic surgeon, and gynecological oncologist with more than 20 years of clinical experience in laparoscopic surgery. He is a clinical advisor to Precision Robotics, and has been involved in the final development of the Sirius Endoscope from October 2020. He has been trained in the use of the Sirius Endoscope.

Intervention, procedures and standard care

The laparoscopic procedures were done in the usual manner. The only difference was for the study participants, the Sirius System was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports remained the same.

For every procedure using the Sirius System, a conventional laparoscope was on immediate standby, to replace the Sirius System should there be an unanticipated equipment failure, so that the procedure could be completed without delay. Video recordings of each procedure were reviewed to ensure the safety of the Sirius System, and that there were no safety concerns arising from the use of the Sirius System.

Outcome measures

Primary outcome was measured by the proportion of women who successfully completed the intended procedure using the Sirius System without conversion to another camera system. The surgeon and nurses’ views of the Sirius System was evaluated by the mean score of the Likert scale questionnaire and free-text comments. Modifications and changes to the Sirius System during the course of the study were recorded as part of the primary outcome measures.

Secondary outcomes were measured by the incidence of intraoperative complications, incidence of postoperative complications during the first 6 weeks following surgery and duration of surgery. Specifically, intraoperative complications directly related to the use of the Sirius System were documented. Duration of surgery was measured in minutes from urinary catheter insertion to closure of vaginal/abdominal wound. Intraoperative or postoperative complications were classified according to the Clavien-Dindo classification during the first 6 weeks of surgery.19

Patient demographics and procedures

A total of 13 consecutive patients were invited and consented to the study. No patient who was eligible was excluded, or declined to participate in the study. The median age was 44 years (range: 30–68 years). Four patients had carcinoma of the uterine corpus. The other nine patients had benign gynecological conditions: three patients had uterine fibroids, four patients had ovarian cysts, one patient had utero-vaginal prolapse and one patient had adenomyosis and endometriosis. Three patients had multiport laparoscopic procedures, eight patients had SILS and two patients had vNOTEs. Eight patients had a hysterectomy. Two patients in addition to hysterectomy had bilateral pelvic lymphadenectomy, as part of their staging procedure for carcinoma of the corpus. One patient had a SILS laparoscopic myomectomy for uterine fibroid. The remaining four patients had ovarian cystectomy. Patient and procedure details are in table 1.

Patient outcomes

Of the 13 patients entered into the study, 11 (85%) successfully completed their procedure using the Sirius System without conversion to a conventional laparoscope. The Sirius System was not used in Case 1 because during the preoperative checks, a labelling issue was identified in the case packaging for the single-use disposable laparoscope. The sterility of the instrument could not be verified, and therefore the case was not allowed to proceed using the Sirius System. An immediate conversion was done to the usual conventional laparoscope, and the procedure was completed without delay. The issue was resolved by providing additional documentation, and all subsequent batches of instruments from Case 5 onwards were provided with the correct labelling according to hospital standards.

For Case 4, the laparoscopic camera head was found to be defective during the procedure, causing a deterioration in image quality. An immediate conversion to the conventional laparoscope was done for safety reasons, and the procedure was completed without further delay. Investigations showed that the technical issue was due to a manufacturing defect. This was corrected, and the issue did not recur again in subsequent cases. The study was paused for 1 month while this issue was addressed by Precision Robotics.

There were no intraoperative complications. Blood loss was insignificant (<5 mL) in six patients (46%) and 100 mL or less in the remaining seven patients. The median number of days in hospital was 4 days (range: 2–6 days). The median operating time was 75 min (range: 40–162 min).

No patient returned to the operating theater within 24 hours of surgery. At 6 weeks of follow-up, one patient (8%) was re-admitted 14 days after the surgery for vaginal bleeding due to vaginal wound dehiscence requiring resuturing under general anaesthesia. This was classified as a Clavien-Dindo Grade IIIb complication. All patients remained well at 6 weeks after surgery. Details of patient outcome are in table 2.

Surgeon and camera operators’ experience of the Sirius System

Regarding the Usability Questionnaire of the Sirius Endoscope System, the individual questions and mean Likert scale score for each question is detailed in table 3. Comments on the individual cases, and suggestions for improvements were detailed in table 4. The score was above 3 for all questions. The highest scores were for the articulated tip with its 3 df of movement and improved field of view. It was the opinion that this was beneficial for the surgery. The surgeon noted in his comments for Case 6 (table 4) that this improved field of view, without moving the handle of the endoscope was particularly advantageous for SILS and vNOTEs procedures, where instrument clashing is a major technical hurdle for conventional endoscopes.

The lowest scores were for image quality, especially the color brilliance and color rendition. It was felt that the image color was too red compared with conventional endoscopes. Familiarity with the joystick control was also an issue, and improved with progress in the learning curve, and modifications to the graphical user interface from Case 5 onwards.

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Iterations and modifications to the Sirius System

The iterations, and modifications to the Sirius System as the case series progressed, and feedback was obtained from the camera operators and surgeon, are detailed in table 4.

Case 1 showed a safety and setup issue, with inadequate labelling of the inner packaging, which did not show an expiry date of the scope. Therefore additional documents were needed to prove the sterility of the instrument, and these were verified by the hospital staff. This issue was resolved with correct labelling of the instruments from Case 5 onwards.

During setup for Case 1, it was also unclear if the connector was correctly connected, and it needed the assistance from a Precision Robotics engineer to verify the connection. This was resolved by incorporating a label indicator to provide a clear visual guide that the connector was correctly connected from Case 5 onwards (figure 2).

The articulated tip with its articulated bending, and wider field of view was helpful to the surgery. However it was noted that there was no indication on the surgical monitor of the position of the articulated tip. This was resolved with a software update and new graphical user interface, whereupon on successful connection of the laparoscope head, a simulated dynamic model would appear on the surgical monitor. This dynamic model provides real-time information on the current position of the articulated tip, and the joystick command status (figure 3).

Image quality and color rendition were issues raised by the surgeon, and he commented that the color of the image was too red. An image setting fix and software update were implemented from Case 5, which allowed the surgeon to choose the image settings and color modes (figure 4). In addition, Precision Robotics is performing detailed analysis on the color outputs of the Sirius System, and of other conventional endoscopic systems, and the results will be used to refine the image processing algorithms.

Manufacturing quality, stability and robustness of the Sirius System was an issue shown in Case 3, 4 and 10. It was noted in Case 3 that while the stated diameter of the endoscope was 10 mm, the actual diameter was measured to be 10.6 mm. This quality control issue was addressed by the manufacturer in later batches of the instruments.

The camera head was found to be defective in Case 4 due to a grounding connection problem during the manufacturing process. All instruments in that batch were recalled, and an investigation was initiated by Precision Robotics. The study was suspended until the new batch of endoscopes were available. Based on the outcome of the investigation, new quality control, test procedures, and test plans were designed. Future endoscopes will need to undergo and pass these tests during the manufacturing process. The grounding connection design is also being reviewed and refined.

An image glitch was noted in Case 10, and subsequent investigations showed that it was due to inadvertent mechanical disconnection of the camera head. The buttons for releasing the camera head could be mistakenly pressed during handling of the endoscope. The mechanical design of the handle is being reviewed to minimize the risk of disconnection by incorporating a two-step lock. Further quality control methods and quality assurance procedures are being designed and will be imposed on the manufacturers of the Sirius System.