3.1. Epidemiological and preoperative clinical characteristics
Over a period of 9 years, 23 patients underwent primary exenterative surgery for locally advanced stages pelvic cancers in our department. The median age at the time of surgery was 55 years (range 43 - 72 years). The origin of the primary tumor was represented by stage IVa cervical cancer (11 cases, 48.9%), stage IVa endometrial cancer (1 case, 4.3 %), stage IVa vaginal cancer (6 cases, 26%), stage IIIb bladder cancer (3 cases, 13%), stage IIIc rectal cancer (1 case, 4.3%) and undifferentiated pelvic sarcoma (1 case, 4.3%).(Table 1). Ten out of the 17 patients with stage IVa cervical or vaginal cancer have already developed a vesico-vaginal (8 women) or recto-vaginal (2 women) fistula at the moment of surgery; also the patient with stage IIIc rectal cancer – a rectovaginal fistula.
Table 1. Demographic characteristics and intraoperative details.
Mean age (years)
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53.5 (43-72)
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Origin of malignancy
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Stage Histological type
|
|
Cervical
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IVa Squamous cell carcinoma
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11 (48.9 %)
|
Endometrial
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IVa Adenocarcinoma
|
1 (4.3 %)
|
Vaginal
|
IVa Squamous cell carcinoma
|
6 (26 %)
|
Bladder
|
IIIb Urothelial carcinoma
|
3 (13 %)
|
Rectum
|
IIIc Adenocarcinoma
|
1 (4.3 %)
|
Undifferentiated pelvic sarcoma
|
1 (4.3 %)
|
Type of exenteration regarding topography
|
|
Total
|
7 (30.5 %)
|
Anterior
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13 (56.5 %)
|
Posterior
|
3 (13%)
|
Type of exenteration regarding the levator ani muscle
|
|
Supralevatorian
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13 (56.5%)
|
Infralevatorian
|
10 (43.5%)
|
Infralevatorian with vulvectomy
|
5 (21.7%)
|
Type of urinary tract reconstruction:
|
|
Non-continent urinary conduit type Bricker
|
20 (87%)
|
Type of bowel reconstruction
|
|
Colostomy
|
7 (30.5%)
|
Colorectal anastomosis
|
3 (13%)
|
Length of surgery (min), median (range)
|
364 (270-560)
|
Estimated blood loss (ml), median (range)
|
600 (300-2100)
|
Transfusion volumes (ml), median (range)
|
700 (0-1800)
|
Hospital stay after PE (days), median (range)
|
20 (11-75)
|
3.2. Procedures and complications of pelvic exenteration
As type of exenterative procedure, related to the tumor involvement of pelvic organs, 7 (30.5%) patients required total exenteration, 13 (56.5%) procedures were anterior and 3 (13%) were posterior exenterations. Regarding the levator ani muscle, with the aim to obtain tumor free resection margins 13 (56.5%) pelvic exenterations were supralevatorian, 10 (43.5%) infralevatorian, and 5 (21.7%) were infralevatorian with vulvectomy.
For the 10 patients with total or posterior pelvic exenterations, a low rectal anastomosis was performed in 3 casesand in 7 patients an end definitive colostomy due to insufficient unaffected rectal stump. Urinary diversion procedures were performed for all patients who underwent a total or anterior exenteration, tailoring a Bricker’s ileal (in 15 patients) or sigmoid (in 5) incontinent conduit [20], technically easier to perform compared to other urinary diversion procedures and also associated with lower rates of postoperative complications. The option for an ileal or sigmoid urinary conduit after total exenteration (of course, in all anteriorexenterations an ileal conduit was performed) have depended of the remaining length of the sigmoid colon and of the avoidance of an unnecessary ileal anastomosis needed for the ileal conduit. All ureteric-enteral anastomoses were adjusted on ‘double J’ ureteral stents in order to prevent a subsequent stenosis. All the patients were maintained in the Intensive Care Unit for more than 4 days for close monitoring due to the complexity of the procedure and antithrombotic prophylaxis, total parenteral nutrition, intravenous albumin, and prophylactic antibiotic treatment were given. On final pathology report, clear resection margins (R0) were achieved only in 19 out of 23 patients (86.2%). All 5 patients with positive margins were sent for adjuvant chemotherapy.
No major intraoperative complications have occurred. Postoperative complications were divided according Clavien-Dindo classification [19]. Seven patients (30.5%) have experienced early complications and one patient a late complication respectively [Table 2]. As early complications, one Clavien-Dindo grade V has been registered – a patient of 46 years old, referred to the hospital for stage IIIB bladder cancer, who underwent an anterior supralevatorian exenteration with no intraoperative complications, has experienced a sudden death in the 16th postoperative day due to a pulmonary embolism, after patient’s home discharge, despite prophylactic anticoagulant treatment. Four patients experienced Clavien-Dindo grade IIIb complications: enteric fistulas - 3 ileal fistulas with peritonitis and one entero-vaginal fistula, all necessitating re-laparotomies and ileum re-anastomosis. Two patients after an infralevatorian exenteration with vulvectomy have developed a perineal wound infection with tissue necrosis, necessitating prolonged local treatment (Clavien-Dindo grade II). Only one patient has experienced a late complication – a ureteric-enteral stenosis solved finally by a unilateral permanent percutaneous nephrostomy.
Table 2. Early and late complications and survival after pelvic exenteration
Early Complications
|
7 (30.5%)
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Clavien-Dindo grade II
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Perineal wound infection
|
2 (8.7 %)
|
Clavien-Dindograde IIIb
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Bowel fistula
|
4 (17.4 %)
|
Clavien-Dindograde V
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Pulmonary embolism
|
1 (4.3 %)
|
Late Complications
|
|
Urostomy stenosis
|
1 (4.3 %)
|
Survival outcomes
|
|
Alive – free of disease
|
15 (65.2%)
|
Deceased
|
8 (34.8%)
|
3.3. Recurrence and Survival outcomes
Over a median follow-up period of 35 months, 8 (34.8%) patients died. The median overall survival (OS) was 33 months (range 1-96 months) (Figure 3). The 2-year and 5-year survival rates were 72% and 66% respectively.
The median disease-free survival (DFS) time was 26.7 months. DFS and OS were analyzed in terms of exenteration type (total vs partial), type of tumor, bladder invasion, rectal invasion, resection margin status and age (as a continuous variable). Univariate analysis showed that status of resection margin was the only factor significantly associated with DFS (p=0.016).
Eight patients had recurrences following pelvic exenteration. The median time to recurrence was 7 months (range, 1-16 months). Five patients had distant recurrences and three had local recurrences. All of the patients with distant recurrences have died from the disease. Out of the 3 patients with local recurrences, 2 have received radiotherapy and one chemotherapy; one is alive and free of disease, the other 2 have died of disease. The median time from recurrence after surgery to death was 7.5 months (range 1-28 months).