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Original research
Trans-inguinal pelvic lymphadenectomy in vulvar cancer patients: TRIPLE pilot study
  1. Giorgia Garganese1,2,
  2. Simona Maria Fragomeni3,
  3. Luigi Della Corte4,
  4. Carmine Conte3,
  5. Benito Marinucci1,
  6. Luca Tagliaferri5,
  7. Stefano Gentileschi6,7,
  8. Giacomo Corrado3,
  9. Giuseppe Vizzielli8 and
  10. Giovanni Scambia1,3
  1. 1 Dipartimento Universitario Scienze della Vita e Sanità Pubblica – Sezione di Ginecologia ed Ostetricia - Università Cattolica del Sacro Cuore, Rome, Italy
  2. 2 Gynecology and Breast Care Center, Mater Olbia Hospital, Olbia, Italy
  3. 3 Unità di Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
  4. 4 Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontostomatologiche, Universita degli Studi di Napoli Federico II, Naples, Italy
  5. 5 U.O.C. Radioterapia Oncologica, Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Lazio, Italy
  6. 6 Unità di Chirurgia Plastica, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, Rome, Lazio, Italy
  7. 7 Istituto di Clinica Chirurgica, Università Cattolica del Sacro Cuore, Rome, Italy
  8. 8 Division of Obstetrics and Gynecology, University Hospital of Udine, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy
  1. Correspondence to Dr Simona Maria Fragomeni, Unità di Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; simona.fragomeni{at}gmail.com

Abstract

Objective The goal of this study was to assess the feasibility and safety of a retrograde extraperitoneal trans-inguinal novel approach to pelvic lymphadenectomy in vulvar cancer patients. The secondary objectives were to assess complications (early and late) and oncological outcomes.

Methods In this pilot study, all patients referred to our institution from November 2019 to May 2021 were evaluated. The inclusion criteria were patients diagnosed with primary/recurrent vulvar cancer and who were candidates for concomitant groin and pelvic lymph node dissection. A consecutive sampling was planned during the study period. After conventional inguino-femoral lymph nodal dissection, ipsilateral extraperitoneal trans-inguinal pelvic lymphadenectomy (TRIPLE) was performed through a groin incision. Clinical data, type of treatment, perioperative complications, and follow-up were evaluated.

Results 13 patients (8 primary, 5 recurrent vulvar cancer) underwent 16 TRIPLE procedures (10 unilateral, 3 bilateral). The median age was 69 years (range 58–93 years); 8 patients had comorbidities (61.5%). Up front locoregional radiotherapy was previously performed in two cases (15.4%). The pathology report showed metastatic lymph nodes in 20 (87%) groins and 11 (68.8%) pelvic sites; the mean number of removed and metastatic pelvic lymph nodes was 12.1 (range 5–33) and 2.9 (range 0–18), respectively. No intra-operative site-specific complications occurred. One (5.9%) post-operative site-specific complication was reported (pelvic abscess, grade 2), which was treated with antibiotics. One patient died due to concomitant pneumonia. No unilateral pelvic lymph node recurrence occurred during follow-up (median 13 months, range 2–43 months); 3 patients (23.1%) had distant site recurrence (median disease-free survival 9 months).

Conclusions TRIPLE seems to be a feasible and safe technique, providing adequate lymph node dissection. Despite being a high-risk and fragile population, morbidity was similar to previously reported data for conventional mini-invasive approaches. Prospective larger comparative series are necessary.

  • gynecologic surgical procedures
  • pelvis
  • surgical oncology
  • SLN and lympadenectomy
  • vulvar and vaginal cancer

Data availability statement

Data are available upon reasonable request. The data presented in this study are available on reasonable request, from the corresponding author. The data are not publicly available due to privacy restriction.

https://doi.org/10.1136/ijgc-2022-003347

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    Data availability statement

    Data are available upon reasonable request. The data presented in this study are available on reasonable request, from the corresponding author. The data are not publicly available due to privacy restriction.

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    Footnotes

    • Contributors Substantial contributions to: Conception or design of the work: GG, SMF; Acquisition, analysis, or interpretation of data for the work: SMF, LDC; Drafting the work or revising it critically for important intellectual content: GG, SMF, LDC, CC, GS; Final approval of the version to be published: all co-authors. Guarantor: GG.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.