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The NOVEL trial: natural orifice versus laparoscopic cholecystectomy—a prospective, randomized evaluation

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Abstract

Introduction

The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy.

Methods

Ninety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes.

Results

There were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p = 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p < 0.05).

Conclusion

The safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.

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Acknowledgements

Special acknowledgement to Barbara Connell, CAE (ASGE) whose administrative expertise was crucial to the success of the study.

Funding

Funders (via unrestricted grants) of the NOSCAR® randomized prospective NOVEL Trial: NOTES versus Laparoscopic Cholecystectomy (in alphabetical order): ASGE®, Covidien (now Medtronic), Ethicon Endosurgery Division of J&J, Karl Storz, Olympus, SAGES®, Stryker Endoscopy.

Author information

Authors and Affiliations

  1. Department of Surgery, The Jacobs School of Medicine, University at Buffalo, The State University of New York, Buffalo, NY, USA

    Steven D. Schwaitzberg

  2. Department of Surgery, Yale School of Medicine, New Haven, CT, USA

    Kurt Roberts

  3. Department of Surgery, University of Massachusetts Medical School, Baystate Medical Center, Springfield, MA, USA

    John R. Romanelli

  4. Department of Medicine, University of Massachusetts Medical School, Baystate Medical Center, Springfield, MA, USA

    David J. Desilets

  5. Lowell General Hospital, Lowell, MA, USA

    David Earle

  6. Department of Surgery, University of California San Diego School of Medicine, San Diego, CA, USA

    Santiago Horgan

  7. Department of Surgery, The Oregon Clinic, Portland Oregon, IHU, Strasbourg, France

    Lee Swanstrom

  8. Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Eric Hungness & Nathaniel Soper

  9. Gastroenterology Division, Department of Medicine, University of Pennsylvania Health System, Philadelphia, PA, 19104, USA

    Michael L. Kochman

Authors
  1. Steven D. Schwaitzberg
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  2. Kurt Roberts
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  4. David J. Desilets
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  5. David Earle
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  6. Santiago Horgan
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  7. Lee Swanstrom
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  8. Eric Hungness
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  9. Nathaniel Soper
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  10. Michael L. Kochman
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Consortia

on behalf of the Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®) Clinical Trial Group

Corresponding author

Correspondence to Steven D. Schwaitzberg.

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Disclosures

Steven D. Schwaitzberg, Kurt Roberts, John R. Romanelli, David J. Desilets, David Earle, Santiago Horgan, Lee Swanstrom, Eric Hungness, Nathaniel Soper, and Michael L. Kochman, on behalf of the Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®) Clinical Trial Group, have no conflicts of interest or financial ties to disclose.

Appendix: measurements of study variables

Appendix: measurements of study variables

Prior to surgery:

  1. 1.

    Subject quality of life assessments will be collected—SF-12

  2. 2.

    Clinical demographics: age, sex, BMI, prior abdominal/pelvic surgical history

  3. 3.

    Clinical indication for procedure

At the time of surgery:

  1. 1.

    Length of surgery

  2. 2.

    Approach (NOTES transvaginal/transgastric, laparoscopic)

  3. 3.

    All instrumentation used as specified on CRF

  4. 4.

    Intraoperative complication

  5. 5.

    Ease of dissection (rating 1–5)

  6. 6.

    Blood loss

  7. 7.

    Conversion to alternate approach

  8. 8.

    Digital image of the abdomen documenting cosmetic appearance for cosmesis score

Post-anesthesia care unit:

  1. 1.

    Pain medication used in PACU (frequency and amount)

  2. 2.

    Antiemetic medication used in PACU (frequency and amount)

  3. 3.

    2-hour post arrival visual analogue pain scale (VAS) and PIQ6

  4. 4.

    Discharge Disposition

  5. 5.

    Length of stay in PACU

Follow-up post-surgery 1:

The postoperative care of the subject was conducted as per surgeon routine.

Recorded outcome measures were collected at the first outpatient postoperative visit (clinically indicated) (approximately 7–10 days, up to 14 days)

  1. 1.

    Length of hospitalization (if any)

  2. 2.

    Use of narcotics/pain medication post operatively from patient log

  3. 3.

    Access site exam

  4. 4.

    Regional assessment of pain (where is pain in abdomen/pelvis if any) VAS and PIQ-6

  5. 5.

    Infection/wound assessment

  6. 6.

    Complications and management

    1. a.

      Subject quality of life assessments will be collected—SF-12

  7. 7.

    Digital image of the abdomen documenting cosmetic appearance for cosmesis score.55

  8. 8.

    Dyspareunia scale (females).

Follow-up post-surgery 2:

Recorded outcome measures were collected at the second outpatient postoperative visit (research related) [approximately 30 days (25–35)]:

  1. 1.

    Length of hospitalization (if any)

  2. 2.

    Use of narcotics/pain medication post operatively from patient log

  3. 3.

    Access site exam

  4. 4.

    Regional assessment of pain (where is pain in abdomen/pelvis, if any)

  5. 5.

    Infection/wound assessment

  6. 6.

    Complications and management

    1. a.

      Subject quality of life assessments will be collected—SF-12

  7. 7.

    Digital image of the abdomen documenting cosmetic appearance for cosmesis score by VASC and Categorical Scale.

  8. 8.

    Marinoff dyspareunia scale (females).

Follow-up post-surgery 3:

Patients were asked to complete SF-12 and dyspareunia scale via questionnaire.

Any ancillary visits (clinically indicated) will also record the following:

  1. 1.

    The reason for the visit

  2. 2.

    Pain as assessed on a VAS

  3. 3.

    Complications

  4. 4.

    Infection/wound assessment.

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Schwaitzberg, S.D., Roberts, K., Romanelli, J.R. et al. The NOVEL trial: natural orifice versus laparoscopic cholecystectomy—a prospective, randomized evaluation. Surg Endosc 32, 2505–2516 (2018). https://doi.org/10.1007/s00464-017-5955-5

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  • DOI: https://doi.org/10.1007/s00464-017-5955-5

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