INTERVENTIONAL PROCEDURES PROGRAMME

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1 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of radical laparoscopic hysterectomy for early stage cervical cancer Introduction This overview has been prepared to assist members of IPAC advise on the safety and efficacy of an interventional procedure previously reviewed by SERNIP. It is based on a rapid survey of published literature, review of the procedure by specialist advisors and review of the content of the SERNIP file. It should not be regarded as a definitive assessment of the procedure. Procedure name Radical laparoscopic hysterectomy Specialty society Royal College of Obstetricians and Gynaecologists Indication(s) Stage I or IIA cervical cancer. The stage of cervical cancer describes how far it has progressed at the time of diagnosis. Stage I cervical cancer is confined to the cervix. Stage IIA cervical cancer has spread to the top of the vagina, but not into the uterus. Cervical cancer that has progressed further than this generally treated with radiotherapy and chemotherapy, but not with surgery. Cervical cancer is relatively uncommon. In London Region in 1999, about 300 new cases were reported, giving an age-standardised incidence of 8 per 100,000 women per year (Source: Thames Cancer Registry). Untreated cervical cancer is almost invariably fatal. Summary of procedure Radical hysterectomy involves surgical removal of the uterus, the supporting ligaments and the upper vagina, together with removal of the pelvic lymph nodes and sometimes the para-aortic lymph nodes. Traditionally, radical hysterectomy is performed through an incision in the abdomen. Laparoscopic radical hysterectomy is a minimally invasive procedure that may reduce length of hospital stay and improve post-operative recovery compared with abdominal surgery. Literature review Radical laparoscopic hysterectomy page 1 of 5

2 Appraisal criteria We included studies that described radical laparoscopic hysterectomy in women with cervical cancer. We excluded studies which described total (ie non radical) laparoscopic hysterectomy or laparoscopic assisted vaginal hysterectomy. List of studies found We found no systematic reviews, randomised controlled trials or cohort studies. We found two case series that included 20 or more women. 1,2 The second study was published in French and we were unable to obtain the full text. 2 Data have been extracted from the abstract only. References to smaller case series including three or more women are provided in the annex. Radical laparoscopic hysterectomy page 2 of 5

3 Summary of key efficacy and safety findings Authors, location, date, patients Key efficacy findings Key safety findings Key reliability and validity issues Spirtos 1 Average operative time: 205 Uncontrolled case series minutes (range 150 to 430 minutes) Case series California USA Date 1994 to 1996 n=78 women with stage I cervical cancer, mean age 42, range 26 to 62) Mean follow up 67 months, standard deviation 16 months, median and range not stated Average length of stay: 3 days (range 1 to 7 days) Average number of lymph nodes sampled (pelvic and aortic): 34 (range 19 to 68) Recurrence: 8 women Estimated 5-year disease free interval after treatment: 90% Intra-operative complications: cystotomy: 3 women blood transfusion: 1 woman laparotomy required: 5 women Post operative complications: uterovaginal fistula:1 woman deep vein thrombosis: 1 woman urinary tract infection: 1 woman vaginal cuff abscess: 1 woman abdominal wall haematoma: 1 woman pelvic lymphocysts: 2 women 6 women also received radiotherapy and 1 woman received radiotherapy plus chemotherapy Long follow up Outcomes appropriate Pomel 2 Case series France Date not stated, published in 1997 n=41 women, age not stated stage IA: 12 women stage IB: 24 women stage IIA: 4 women stage IIB: 1 woman Estimated 5-year survival: 94% Mean duration of procedure: 270 minutes Mean post operative stay: 7 days Recurrence in follow-up period: none Blood transfusion: 1 woman No major operative and postoperative complications Uncontrolled case series Abstract only available Follow up 4 to 76 months Radical laparoscopic hysterectomy page 3 of 5

4 Validity and generalisability of the studies We found two case series, both performed in settings appropriate to the UK. Follow up appears fairly long in the first study, 1 and was long for some women in the second study. 2 There were no women with Stage II cervical cancer in the first study, 1 and only 5 in the second study. 2 Bazian comments None. Specialist advisor s opinion / advisors opinions Few gynaecological oncologists undertake this procedure regularly. The requirement for radical hysterectomy has fallen considerably. Radical laparoscopic hysterectomy requires extensive laparoscopic expertise. Issues for consideration by IPAC None other than those discussed above. Radical laparoscopic hysterectomy page 4 of 5

5 References 1. Spirtos NM, Eisenkop SM, Schlaerth JB, Ballon SC. Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy in patients with stage I cervical cancer: Surgical morbidity and intermediate follow-up. Am J Obstet Gynecol 2002; 187 (2): Pomel C, Canis M, Mage G, Dauplat J, Le Bouedec G, Raiga J, Pouly JL, Wattiez A, Bruhat MA. Laparoscopically extended hysterectomy for cervical cancer: technique, indications and results. Apropos of a series of 41 cases in Clermont (French). Chirurgie 1997; 122: Annex: References to smaller case series Reference Kim DH, Moon JS. Laparoscopic radical hysterectomy with pelvic lymphadenectomy for early, invasive cervical carcinoma. Journal of the American Association of Gynecologic Laparoscopists 1998; 5: Nezhat CR, Nezhat FR, Burrell MO, Ramirez CE, Welander C, Carrodeguas J, Nezhat CH. Laparoscopic radical hysterectomy and laparoscopically assisted vaginal radical hysterectomy with pelvic and paraaortic node dissection. Journal of Gynecologic Surgery 1993; 9: Canis M, Mage G, Pouly JL, Pomel C, Wattiez A, Glowaczover E, Bruhat MA. Laparoscopic radical hysterectomy for cervical cancer. Baillieres Clinical Obstetrics & Gynaecology 1995; 9: Hsieh Y-Y, Lin W-C, Chang C-C, Yeh L-S, Hsu T-Y, Tsai H-D. Laparoscopic radical hysterectomy with low paraaortic, subaortic and pelvic lymphadenectomy: Results of short-term follow-up. Journal of Reproductive Medicine for the Obstetrician & Gynecologist 1998; 43: Ostrzenski A. A new laparoscopic abdominal radical hysterectomy: A pilot phase trial. European Journal of Surgical Oncology 1996; 22: Number of study participants 18 <18 relevant cases Overview prepared by: Bazian Ltd November 2002 Radical laparoscopic hysterectomy page 5 of 5

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