Introduction of peri-operative care bundle in vulval cancer in a UK regional cancer center

Vulval cancer (VC) is an uncommon gynaecological malignancy mostly affecting postmenopausal women. Surgical treatment is associated with high morbidity. Implementation of a “care bundle” of clinical interventions would potentially improve peri-operative outcomes in these patients. The aim of the study is to assess the impact of implementing a care bundle. These data were taken forward as a baseline, after implementation of the care bundle, for comparison as to the impact of the intervention. A literature and guideline review were undertaken to assist with the construction of the care bundle to standardise the care of the VC patient at Belfast City Hospital (BCH). The control group (pre care bundle implementation) included all patients who underwent curative intent surgery for VC from 01 January 2017 until 31 December 2018 at BCH. All patients in this group had pre- and post-operative care according to individual surgical oncologist preference. Study group (post care bundle implementation) included a prospective sample from 01 January 2023 until May 2023 with similar characteristics and comorbidities to the control group. They were followed up for four months. All data were collected electronically and statistical analysis performed including t test 2 samples assuming unequal variable using Excel 2016. Total number of patients in the control group was 40 and in the study group was 14. Complication was less prevalent in the study group (35.7%) compared to 55% in the control group. Moreover, the study group had significantly shorter hospital stay, lower rate of cellulitis in both groin and vulval area and lower rate of hospital re-admission. Major vulval excisions are recognised to be associated with high morbidity. An evidence based team agreed that selection of uniform interventions has been shown to lead to standardisation of care and improvement in the incidence of complications and morbidity.

Vulval cancer; Vulva; Vulval care bundle; Radical vulvectomy; Groin dissection; Sentinel lymph node

[1] Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA: A Cancer Journal for Clinicians. 2011; 61: 212–236.

[2] Berek JS, Friedlander M, Hacker NF. Berek and Hacker’s gynecologic oncology. In Berek JS, Hacker NF (eds.) Epithelial ovarian, fallopiantube and peritoneal cancer (pp. 443–508). 5th edn. Lippincott Williams & Wilkins: Philadelphia. 2009.

[3] American cancer society: cancer facts and figures 2024. American cancer society. 2024. Available at: https://seer.cancer.gov/statfacts/html/vulva.html (Accessed: 17 January 2024).

[4] Olawaiye AB, Hagemann I, Bhoshale P, Rous BA, Gress DM, Williams AJ, et al. AJCC cancer staging system: vulva. In Goodman KA, Gollub M, Eng C, Brierley J, Palefsky J, Gress D (eds.) AJCC Cancer Staging System. 9th edn. American College of Surgeons: Chicago. 2023.

[5] American society of clinical oncology (ASCO). Vulvar cancer: statistics. 2023. Available at: www.cancer.net/cancer-types/vulvar-cancer/statistics (Accessed: 17 January 2024).

[6] Matsuo K, Klar M, Nishio S, Mikami M, Roman LD, Wright JD. Validation of the 2021 FIGO staging schema for advanced vulvar cancer. International Journal of Gynecologic Cancer. 2022; 32: 474–479.

[7] British Gynaecological Cancer Society: Royal College of Obstetrics and Gynaecology. Guidelines for the diagnosis and management of vulvar carcinoma. 2014. Available at: https://www.rcog.org.uk/media/dqwnw2a1/vulvalcancerguideline.pdf (Accessed: 01 May 2014).

[8] Olawaiye AB, Cuello MA, Rogers LJ. Cancer of the vulva: 2021 update. International Journal of Gynecology & Obstetrics. 2021; 155: 7–18.

[9] McComiskey MH, Robinson A, Hoo C, Khan K, Price JH. Radical excision of vulval disease and multidisciplinary tissue flap reconstruction: the belfast experience. International Journal of Gynecological Cancer. 2012; 22: 323–327.

[10] Zapardiel I, Iacoponi S, Coronado PJ, Zalewski K, Chen F, Fotopoulou C, et al. Prognostic factors in patients with vulvar cancer: the VULCAN study. International journal of gynecological cancer. 2020; 30: 1285–1291.

[11] Gentileschi S, Caretto AA, Servillo M, Stefanizzi G, Alberti C, Garganese G, et al. Feasibility, indications and complications of SCIP flap for reconstruction after extirpative surgery for vulvar cancer. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2022; 75:1150–1157.

[12] Oonk MHM, Planchamp F, Baldwin P, Mahner S, Mirza MR, Fischerová D, et al. European society of gynaecological oncology guidelines for the management of patients with vulvar cancer—update 2023. International Journal of Gynecological Cancer. 2023; 33: 1023–1043.

[13] Fanfani F, Garganese G, Fagotti A, Lorusso D, Gagliardi ML, Rossi M, et al. Advanced vulvar carcinoma: is it worth operating? A perioperative management protocol for radical and reconstructive surgery. Gynecologic Oncology. 2006; 103: 467–472.

[14] Franchelli S, Leone MS, Bruzzone M, Muggianu M, Puppo A, Gustavino C, et al. The gluteal fold fascio-cutaneous flap for reconstruction after radical excision of primary vulvar cancers. Gynecologic Oncology. 2009; 113: 245–248.

[15] Lakhman Y, Vargas HA, Reinhold C, Akin EA, Bhosale PR, Huang C, et al. ACR Appropriateness Criteria® staging and follow-up of vulvar cancer. Journal of the American College of Radiology. 2021; 18: S212–S228.

[16] Morrison J, Baldwin P, Hanna L, Andreou A, Buckley L, Durrant L, et al. British gynaecological cancer society (BGCS) vulval cancer guidelines: An update on recommendations for practice 2023. European Journal of Obstetrics, Gynecology, and Reproductive Biology. 2024; 292: 210–238

[17] McCluggage WG. Carcinoma of the vulva histopathology reporting guide. In International Collaboration on Cancer Reporting. 2021. Available at: https://pubmed.ncbi.nlm.nih.gov/36305532/ (Accessed: 10 October 2022).

[18] Altman AD, Robert M, Armbrust R, Fawcett WJ, Nihira M, Jones CN, et al. Guidelines for vulvar and vaginal surgery: enhanced recovery after surgery society recommendations. American Journal of Obstetrics & Gynecology. 2020; 223: 475–485.

[19] Health Research Authority. What approvals and decisions do I need? 2024. Available at: https://www.hra-decisiontools.org.uk/research/glossary.html#S (Accessed: 05 July 2024).

[20] Dindo D, Demartines N, Clavien P. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Annals of Surgery. 2004; 240: 205–213.

[21] Center for Diseases Control and Prevention. Cellulitis: all you need to know. 2022. Available at: https://www.cdc.gov/groupastrep/diseases-public/Cellulitis.html (Accessed: 01 March 2024).

[22] Van Diest PJ, van der Zee A. Ultra-staging of the sentinel node. In Levemback C, van der Zee AGJ, Coleman RL (eds.) Clinical lymphatic mapping in gynecological cancers (pp. 85Y100). 1st edn. Taylor and Francis: London. 2004.

[23] Hampl M, Hantschmann P, Michels W, Hillemanns P. Validation of the accuracy of the sentinel lymph node procedure in patients with vulvar cancer: results of a multicenter study in Germany. Gynecologic Oncology. 2008; 111: 282–288.

[24] Mullen MM, Merfeld EC, Palisoul ML, Massad LS, Woolfolk C, Powell MA, et al. Wound complication rates after vulvar excisions for premalignant lesions. Obstetrics & Gynecology. 2019; 133: 658–665.

[25] Wills A, Obermair A. A review of complications associated with the surgical treatment of vulvar cancer. Gynecologic Oncology. 2013; 131: 467–479.

[26] Milliken S, May J, Sanderson PA, Congiu MA, D’Oria O, Golia D’Augè T, et al. Reducing the radicality of surgery for vulvar cancer: are smaller margins safer? Minerva Obstetrics and Gynecology. 2021; 73: 160–165.

[27] Weikel W, Hofmann M, Steiner E, Knapstein PG, Koelbl H. Reconstructive surgery following resection of primary vulvar cancers. Gynecologic Oncology. 2005; 99: 92–100.

[28] Cirik DA, Karalok A, Ureyen I, Tasci T, Kalyoncu R, Turkmen O, et al. Early and late complications after inguinofemoral lymphadenectomy for vulvar cancer. Asian Pacific Journal of Cancer Prevention. 2015; 16: 5175–5179.

[29] Witte MB, Barbul A. General principles of wound healing. Surgical Clinics of North America. 1997; 77: 509–528.

[30] Stanczyk M, Olszewski W, Gewartowska M, Maruszynski M. Lack of healing reaction in the cancer wound. Polish Journal of Pathology. 2014; 65: 267–275.

[31] Oonk MHM, Slomovitz B, Baldwin PJW, van Doorn HC, van der Velden J, de Hullu JA, et al. Radiotherapy versus inguinofemoral lymphadenectomy as treatment for vulvar cancer patients with micrometastases in the sentinel node: results of GROINSS-V II. Journal of clinical oncology. 2021; 39: 3623–3632

[32] Carter J, Huang HQ, Armer J, Carlson JW, Lockwood S, Nolte S, et al. GOG 244—The Lymphedema and Gynecologic cancer (LeG) study: the impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function. Gynecologic Oncology. 2021; 160: 244–251.

[33] Kloosterman R, Wright GWJ, Salvo-Halloran EM, Ferko NC, Mennone JZ, Clymer JW, et al. An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes. BMC Surgery. 2023; 23: 180.