Near Infrared Fluorescent Manipulator During Minimally Invasive Sacrocolpopexy: A Pilot Study

doi:10.21203/rs.3.rs-4706866/v1

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Near Infrared Fluorescent Manipulator During Minimally Invasive Sacrocolpopexy: A Pilot Study

https://doi.org/10.21203/rs.3.rs-4706866/v1

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Objective: The objective of this paper is to evaluate fluorescent guided surgery using a near infrared (NIR) fluorescent vaginal/rectal manipulator during minimally invasive sacrocolpopexy.

Methods: This was a pilot study of fluorescent pelvic manipulators in women undergoing previously scheduled reconstructive pelvic surgery. Subjects were eligible if a traditional 30mm end-to-end anastomosis (EEA) sizer was planned for use during the participant’s surgery. The prototype devices under study were developed with a patent protected polymer that fluoresces under NIR imaging. Measurement outcomes include subjective feedback from the surgical team, the frequency in which the surgeon reverted back to a traditional steel manipulator, adverse intraoperative complications and video documentation of findings.

Results: Twenty subjects were enrolled. The fluorescent manipulator could be visualized through vaginal/rectal tissue in all surgeries and no intraoperative complications were noted. The surgeons continued with the fluorescent manipulator, over the traditional manipulator, in 100% of the cases. Subjectively, the operating staff noted improved communication, increased confidence in the surgical learner and enhanced visualization of the anatomy. On review of the videos, fluorescent NIR transillumination of the tissue highlighted anatomic distortion in 60% of the available videos.

Conclusion: Fluorescent vaginal/rectal manipulators transilluminated the tissue allowing for real time visual information and better surgical decision making; in addition, it increased communication between surgical teacher and learner as anatomic borders and surgical planes were highlighted with fluorescence. With improved visualization, there is a potential to decrease unintentional perforations, reduce operating room time and improve communication with surgical learners and surgical team members.

Fluorescent Guided Surgery

Innovation

Minimally Invasive Gynecologic Surgery

Surgeries are becoming more complex as the population ages [1], becomes more obese[2] and Americans, on average, have 9.17 surgical procedures over a lifetime [3]. All of these variables make surgery more complicated medically and technically. In response to increased complexity, industry partners have responded by making minimally invasive surgical systems with enhanced visualization. For example, surgical systems offer 3D, high definition, Chroma and near infrared (NIR) visualization in a variety of combinations.

NIR features are standard on many surgical systems and allow the surgeon to see outside of the visible light spectrum. This is surgically relevant because the NIR wavelength is not absorbed by water and allows the surgeon to see below the level of the parietal peritoneum to approximately 1cm [4]. When a surgeon operates in the NIR wavelength it is called fluorescent guided surgery.

Fluorescent guided surgery was introduced to minimally invasive surgery commercially in 2011 when Intuitive launched the da Vinci Firefly technology [5]. Since then, it has become ubiquitous and is available on the majority of commercially available surgical systems. Surgical NIR provides enhanced, real time visual feedback and allows the surgeon to make better informed decisions. The use of NIR surgical techniques has had a major impact on general surgery and oncologic surgery [6]. For example, in gynecologic oncology surgery, NIR imaging is used for sentinel lymph node identification in vulvar and cervical operations [7]. More recently, tumor-targeted NIR probes, such as pafolacianine, have been used in cytoreductive and staging of ovarian cancer [8]. In all of these clinical scenarios, an injection of a NIR dye is given to the patient. This is helpful for NIR angiography, lymph node detection or tumor location. However, the majority of surgeries do not require angiography or tumor/lymph node identification.

The current technology available in surgical systems and the surgical difficulties experienced by most surgeons, particularly scarred or distorted tissue planes, inspired our team to investigate the potential of surgical instruments that fluoresce under NIR.

In a tertiary academic hospital setting, patients scheduled for robotic assisted sacrocolpopexy or similar reconstructive pelvic surgery were approached for participation in the study. Women between the ages of 18–100 years old were included. Exclusion criteria included pregnancy or anatomy that would not permit use of a vaginal/rectal manipulator (i.e., absence of a rectum/vagina).

After informed consent, the subject was taken to the operating room and the surgeon’s standard positioning, anesthesia and operative flow were initiated. The surgeon used the fluorescent manipulator instead of the traditional steel manipulator. The surgeon activated the NIR Firefly feature while performing initial surveillance of the pelvic anatomy and then returned to the standard visible light imaging. At this point, the surgeon had the discretion to continue the surgery with the fluorescent manipulator or return to their standard manipulator of choice. At the conclusion of the surgery, the operating room staff, consisting of the surgeon, surgical learners and first assist, was asked open ended questions about the use of the fluorescent manipulator and the surgical video was reviewed. Intra and post-operative complications were noted. Qualitative analysis was implemented.

Pelvic Manipulators

The manipulators were supplied by a local start-up company (EndoGlow, Rochester, NY). The 30mm EEA-sizer rectal/vaginal manipulator was created with a proprietary polymer that includes medical grade acrylonitrile butadiene styrene (ABS) and a NIR fluorophore. (See Fig. 1) After the appropriate pre-operating room testing, including cleaning, sterilization and packaging protocols were complete, Institutional Review Board approval was granted.

Figure 1

Minimally Invasive NIR Imaging System

For this pilot study we used the da Vinci Xi (Intuitive Surgical, Sunnyvale, CA) with Firefly technology. The system comprises an excitation light source (803 nm) which activates the fluorophore in the pelvic manipulator. The emitted NIR light (700–830 nm) from the manipulator is detected by a NIR filter and pseudo colored as green into the image seen on the monitor [5].

A total of 20 subjects were enrolled for this study by 3 surgeons. The surgeons belonged to the Division of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) or Colon and Rectal surgery, all specializing in reconstructive pelvic surgery. Intraoperatively, the fluorescence of the manipulator could be seen in the rectum and/or vagina during NIR mode in all of the cases. In 100% (20/20) of the procedures, the surgeon elected to use the fluorescent manipulator instead of returning to the standard steel manipulator for the remainder of the case interchanging between the visible light and NIR/Firefly view. In 15% of the surgeries (3/20), the surgeon included an additional manipulator to improve anatomic visualization. In these three cases, a Breisky retractor was used to upwardly deviate the vagina and the fluorescent rectal EEA sizer was used concurrently for rectal dissection. In total 20 sacrocolpopexies were performed; there were 12 concomitant hysterectomies, 10 concomitant anterior and/or posterior colporrhaphies; 8 mid-urethral slings, and two were combined with a rectopexy.

After the conclusion of the surgery, the operative team provided oral, open-ended feedback prompted by predetermined verbal questions. Three overarching themes were noted. 1) Enhanced visualization of anatomic features 2) Improved communication between surgeon and operative team 3) Increased confidence in performance of surgical learner. See Table 1 for additional statements from the operative team.

Table 1

Open-ended Questions and answers asked of the operating room team (attending surgeon, surgical learner, nursing first assist)
Questions	Answers
What did you like about the device?	“It was easy to use.” “I could see the anatomy so much better, especially in difficult cases.” “I think it made the case quicker.”
What would you change about the device?	“I would make it in different shapes, like a longer cone shape or breisky.” “I would like the handle to be reusable.”
What surprised you about the device?	“It gave additional landmarks as reference points when talking to the Fellow.” “I felt like I operated better.”

Video footage review of each case was attempted. Due to technical difficulties only 5 of the videos could be reviewed in part or parcel. The videos confirmed enhanced visualization, as evidenced by the following four intraoperative images:

The standard view of the bladder looked uncomplicated. When the NIR mode was activated, the anatomic distortion of the bladder could be easily visualized (Photo 1).

Photo 1: Vagina and bladder in visible light (left); vagina and bladder in NIR (right) with fluorescent manipulator in the vagina.

Similarly, bladder dissection on a severely scarred bladder was aided by NIR by identifying the safest point to begin the dissection (Photo 2). The surgeon knew the least amount of tissue showed the most fluorescence and was least likely to involve the bladder.

Photo 2: Post-hysterectomy vagina and bladder with scarring in the visible light (left); vagina and bladder in NIR (right) with fluorescent manipulator in the vagina.

In another surgery, a concomitant vaginal anterior colporrhaphy was performed before the laparoscopic portion of the surgery, resulting in alteration of the anatomy of the anterior vaginal wall and mesh placement. The NIR feature allowed the surgeon to assess spread of a hematoma, locate previous suture lines and determine appropriate positioning of the mesh (Photo 3).

Photo 3: Hematoma after anterior colporrhaphy with mesh placement in the visible light (left); and NIR (right) with fluorescent manipulator in the vagina.

The fluorescent manipulator served as an impromptu protection against suturing the mesh to the bladder edge or incidental vaginotomy (Photo 4).

Photo 4: Anterior vagina confirming bladder dissection before mesh placement in NIR with fluorescent manipulator in the vagina.

For the reviewed videos, anatomic distortions were seen 60% (3/5) of the time and confirmed bladder safety prior to fixation of the mesh 100% of the time. As the Urogynecology and Reconstructive Pelvic Surgery (URPS) Fellow was participating in the dissection, increased confidence in identifying the vaginal tissues and surgical planes was reported by the fellow, first assist and attending surgeon.

This study demonstrated subjective usefulness of a fluorescent pelvic manipulator to enhance visualization and increase communication amongst the operating team when used in conjunction with a NIR surgical system.

Our study shows improved visualization when transilluminating the vagina or rectum with a fluorescent pelvic manipulator. The added NIR contrast between the bladder, for example, and the vagina provided visual confirmation and reassurance that the bladder was safely dissected before securing mesh. This contrast defined the bladder edge during bladder dissection, which proved to be most useful with distorted anatomy. Given the paucity of video data collected, it is unclear if anatomic distortions would have been seen less or more frequently. An unexpected outcome of this pilot study was an improvement in communication amongst the operative team. Surgeons with many years of training and experience are able to see surgical planes and anatomic details that surgical learners and surgical assistants do not appreciate. By introducing fluorescence induced contrast between organs, these surgical planes were more visible to all members of the operative team. This could support the increased confidence in performance of and by the surgical learner.

Minimally invasive surgery has become prevalent in gynecologic surgery, but fluorescent guided surgical applications for general gynecology have been limited. We believe pelvic manipulators that enhance visualization, in addition to providing standard manipulation, can improve surgical outcomes.

The strengths of this pilot study include the novel use of a fluorescent device, use across two pelvic surgery specialties in the complex setting of reconstructive pelvic surgery. This allowed us to test the device in a variety of anatomic environments. The limitations include, a limited number of subjects and fluorescent manipulators. We were limited to performing procedures in a robotic-assisted manner and did not incorporate traditional straight-stick laparoscopy. The study was completed at a tertiary referral center which may skew the results as patients may be more complex than typically seen in the community and may not be generalizable.

Future research directions could include the evaluation of operative times, shortening the learning curve of surgical fellows and/or applying the manipulators to a variety of surgical applications and surgical systems.

The current and most prevalent methods for using NIR involve injection of a dye (i.e., indocyanine green, tagged nanoparticles) into the patient. As stated earlier, this is excellent for angiography, sentinel lymph node identification and oncologic surgery. However, very few surgeries benefit from this application of fluorescent guided surgery. By putting fluorescence into surgical instruments, we believe NIR could enhance most surgeries and provide an additional educational tool for learning institutions.

1. Biffl, W.L. and S.E. Biffl, Rehabilitation of the geriatric surgical patient: predicting needs and optimizing outcomes. Surg Clin North Am, 2015. 95(1): p. 173 − 90.

2. Montgomery, C., Obesity is associated with larger soft-tissue sarcomas, more surgical complications, and more complex wound closures (obesity leads to larger soft‐tissue sarcomas). Journal of Surgical Oncology, 2018. 118(1): p. 184–191.

3. Lee, P.H.U. and A.A. Gawande, The number of surgical procedures in an American lifetime in 3 states. Journal of the American College of Surgeons, 2008. 207(3): p. S75.

4. Sardar, H.S., Zai, Q., Gunn, J., Pogue, B., Paulsen, K., Samkoe, K., & Henderson, E., Comparison of detection sensitivity of near infrared (NIR) surgical imaging systems using a connective tissue phantom model. Proceedings of SPIE, the International Society for Optical Engineering, 2019. 10862: p. 108620Z–108620Z–9.

5. Mahdi Azizian, M.L., Iman Khalaji, Jonathan Sorger, Daniel Oh, Simon Daimios, The da Vinci Surgical System. Handbook of Robotic and Image-Guided Surgery, 2020: p. 39–55.

6. Mieog, J.S.D., et al., Fundamentals and developments in fluorescence-guided cancer surgery. Nature Reviews Clinical Oncology, 2022. 19(1): p. 9–22.

7. Handgraaf, H.J., Verbeek, F. P. ., Tummers, Q. R. J. ., Boogerd, L. S. ., van de Velde, C. J. ., Vahrmeijer, A. L., & Gaarenstroom, K. N., Real-time near-infrared fluorescence guided surgery in gynecologic oncology: A review of the current state of the art. Gynecologic Oncology, 2014. 135(3): p. 606–613.

8. Dindere, M.E., Tanca, A., Rusu, M., Liehn, E. A., & Bucur, O., Intraoperative Tumor Detection Using Pafolacianine. International Journal of Molecular Sciences, 2022. 23(21): p. 12842.

Photo 1: Vagina and bladder in visible light (left); vagina and bladder in NIR (right) with fluorescent manipulator in the vagina.

Photo 3: Hematoma after anterior colporrhaphy with mesh placement in the visible light (left); and NIR (right) with fluorescent manipulator in the vagina.

Photo 4: Anterior vagina confirming bladder dissection before mesh placement in NIR with fluorescent manipulator in the vagina.

Table 1

Open-ended Questions asked of the Operating Room Staff (Attending surgeon, surgical learner and nurse first-assist).
Questions	Answers
What did you like about the device?	“It was easy to use.” “I could see the anatomy so much better, especially in difficult cases.” “I think it made the case quicker.”
What would you change about the device?	“I would make it in different shapes, like a longer cone shape or breisky.” “I would like the handle to be reusable.”
What surprised you about the device?	“It gave additional landmarks as reference points when talking to the Fellow.” “I felt like I operated better.”

Source of Funding: This work was supported by the University of Rochester Technology Development Grant

Statement of prior presentation: A video presentation on this project was presented at Society of Gynecologic Surgeons in March 2022.

Conflict of Interest Statement: Authors do not have a financial or non-financial interest to disclose.

Author Contributions: All authors recruited subjects, participated in collection of data and contributed to manuscript generation.

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Research Subject Review Board at the University of Rochester: IRB# 0003554, August 2021.

Consent to Participate: Informed written consent was obtained from all the individual subjects included in the study. It is affirmed that publication of images is anonymized.

Biffl, W.L. and S.E. Biffl, Rehabilitation of the geriatric surgical patient: predicting needs and optimizing outcomes. Surg Clin North Am, 2015. 95(1): p. 173-90.
Montgomery, C., Obesity is associated with larger soft‐tissue sarcomas, more surgical complications, and more complex wound closures (obesity leads to larger soft‐tissue sarcomas). Journal of Surgical Oncology, 2018. 118(1): p. 184-191.
Lee, P.H.U. and A.A. Gawande, The number of surgical procedures in an American lifetime in 3 states. Journal of the American College of Surgeons, 2008. 207(3): p. S75.
Sardar, H.S., Zai, Q., Gunn, J., Pogue, B., Paulsen, K., Samkoe, K., & Henderson, E., Comparison of detection sensitivity of near infrared (NIR) surgical imaging systems using a connective tissue phantom model. Proceedings of SPIE, the International Society for Optical Engineering, 2019. 10862: p. 108620Z–108620Z–9.
Mahdi Azizian, M.L., Iman Khalaji, Jonathan Sorger, Daniel Oh, Simon Daimios, The da Vinci Surgical System. Handbook of Robotic and Image-Guided Surgery, 2020: p. 39-55.
Mieog, J.S.D., et al., Fundamentals and developments in fluorescence-guided cancer surgery. Nature Reviews Clinical Oncology, 2022. 19(1): p. 9-22.
Handgraaf, H.J., Verbeek, F. P. ., Tummers, Q. R. J. ., Boogerd, L. S. ., van de Velde, C. J. ., Vahrmeijer, A. L., & Gaarenstroom, K. N. , Real-time near-infrared fluorescence guided surgery in gynecologic oncology: A review of the current state of the art. Gynecologic Oncology, 2014. 135(3): p. 606-613.
Dindere, M.E., Tanca, A., Rusu, M., Liehn, E. A., & Bucur, O., Intraoperative Tumor Detection Using Pafolacianine. International Journal of Molecular Sciences, 2022. 23(21): p. 12842.

Photos 1 to 4 are available in the Supplementary Files section

No competing interests reported.

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You are reading this latest preprint version

Near Infrared Fluorescent Manipulator During Minimally Invasive Sacrocolpopexy: A Pilot Study

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Abstract

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Introduction

Materials and Methods

Pelvic Manipulators

Minimally Invasive NIR Imaging System

Results

Discussion

Declarations

References

Photos

Additional Declarations

Supplementary Files

Status:

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