Article Text
PDF
Abstract
Background Pelvic exenteration and its reconstructive techniques have been associated with high postoperative morbidity and a negative impact on patient quality of life. The aim of our study was to compare postoperative complications and quality of life in patients undergoing continent compared with non-continent urinary diversion after pelvic exenteration for gynecologic malignancies.
Methods We designed a multicenter study of patients from 10 centers who underwent an anterior or total pelvic exenteration with urinary reconstruction for histologically confirmed persistent or recurrent gynecologic malignancy after previous treatment with radiotherapy. From January 2005 to September 2008, we included patients retrospectively, and from September 2008 to May 2009, patients were included prospectively which allowed collection of quality of life data. Demographic, surgical, and follow-up data were analyzed. Postoperative complications were classified according to the Clavien–Dindo classification. Quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30 (V.3.0) and EORTC-QLQ-OV28 quality of life questionnaires. We compared patients who underwent a continent urinary diversion with those who underwent a non-continent reconstruction.
Results We included 148 patients, 92 retrospectively and 56 prospectively. Among them, 77.4% had recurrent disease and 22.6% persistent disease after the primary treatment. In 70 patients, a urinary continent diversion was performed, and 78 patients underwent a non-continent diversion. Median age of the continent and incontinent groups was 53.5 (range 33–78) years and 57 (26-79) years, respectively. There were no significant differences between the continent and non-continent groups in median length of hospitalization (28.5 vs 26 days, P=0.19), postoperative grade III–IV complications (42.9% vs 42.3%, P=0.95), complications needing surgical (27.9% vs 34.6%, P=0.39) or radiological (14.7% vs 12.8%, P=0.74) intervention, and complication type (digestive (23.2% vs 16.7%, P=0.32) and urinary (15.9% vs 16.7%, P=0.91)). There were no significant differences between the groups in global health, global quality of life, and body image perception scores 1 year after surgery.
Conclusion Continent and incontinent urinary reconstructions are equivalent in terms of postoperative complications and quality of life scores.
- gynecologic cancer
- anterior pelvic exenteration
- continent urinary reconstruction
- incontinent urinary reconstruction
- global health
- body image
Statistics from Altmetric.com
- gynecologic cancer
- anterior pelvic exenteration
- continent urinary reconstruction
- incontinent urinary reconstruction
- global health
- body image
HIGHLIGHTS
Postoperative complication rates after continent versus non-continent urinary reconstruction are similar.
Continent versus incontinent urinary diversions after pelvic exenteration are equivalent in terms of quality of life.
The main complications after anterior or total pelvic exenteration and urinary diversion are digestive and infectious complications.
Introduction
Despite improvements in local control of gynecologic malignancies treated with concomitant chemoradiotherapy, pelvic exenteration can be a curative treatment for almost 30% of non-metastatic patients with recurrent or persistent pelvic disease after prior radiation therapy.1 Urinary diversion after anterior or total pelvic exenteration represents an essential part of surgical reconstruction. There has been a significant evolution in surgical approaches to urinary diversion in the field of gynecological oncology over the past 70 years; however, achieving successful long term function and adequate quality of life are still challenging.2 The goal of urinary diversion after cystectomy has evolved from simple diversion—such as cutaneous bilateral ureterostomy—to functioning and anatomic reconstruction as close as possible to the physiologic preoperative status.3 Many types of urinary diversion have been developed. There are non-continent techniques, such as the Bricker ileal conduit,4 and continent urinary diversions, such as the Koch pouch with an ileal reservoir5 or the Miami pouch which is created with a segment of distal ileum and ascending colon.6 Chiva et al proposed urinary reconstruction with a Y shaped neobladder created with a detubularized ileum connected to the proximal urethra for patients with cervical cancer after pelvic exenteration.7
Along with the increase in survival rates of these patients, improving their quality of life has become a major issue. Some studies showed that after a year, regardless of the type of urinary reconstruction, patients had similar scores for global quality of life and physical, cognitive, and social functioning.8 To our knowledge, there are very few studies comparing postoperative complications between continent and non-continent urinary diversion after pelvic exenteration for gynecologic malignancies, and most studies are from urologic series. None has shown any significant differences, except a higher risk of stone formation in patients undergoing continent reconstruction. Moreover, none of these studies compared patients' quality of life.9–12
The aim of our study was to compare the complication rate and quality of life of patients undergoing continent versus non-continent urinary diversion after pelvic exenteration for gynecologic malignancies.
Methods
Patients and Study Design
We designed a multicenter French study (Soutien aux Techniques Innovantes et Coûteuses (STIC) Pelvic Exenteration) of patients from 10 centers who underwent an anterior or total pelvic exenteration with urinary reconstruction. From January 2005 to September 2008, we included patients retrospectively, and from September 2008 to May 2009, patients were included prospectively which allowed collection of quality of life data. Patients meeting the following inclusion criteria were included in our study: diagnosis of a persistent or recurrent gynecologic malignancy after prior radiotherapy confirmed by biopsy; good performance status (score of 0 or 1 according to the World Health Organization classification); no extra pelvic disease on positron emission tomography–computed tomography; pelvic exenteration performed with a curative purpose; and urinary diversion performed at the time of surgery. The type of pelvic exenteration was classified according to the Magrina classification: type I (supralevator), type II (infralevator), and type III (with vulvectomy). The type of urinary reconstruction was classified as continent diversion if a Kock,5 13 Indiana,6 or Miami14 pouch was performed, or as non-continent diversion if a colonic conduit, ileal, or jejunal Bricker4 or bilateral ureterostomy10 (online supplementary file 3) was performed. None of our patients underwent urinary reconstruction with an ileal orthotopic neobladder as this technique was not used during the study period.
Supplemental material
Informed consent was obtained from all patients prospectively included. Institutional review board approval was obtained from all centers.
Study Data
The following data were retrieved from records for retrospectively included patients and were prospectively collected for the remaining patients: age at diagnosis, American Society of Anesthesiologists score, medical comorbidity, previous abdominal surgery, site of primary gynecologic tumor, histologic subtype, previous surgical treatment or chemotherapy, age at the time of exenteration, surgical indication for exenteration, interval between last radiotherapy and exenteration, type of exenteration, surgical data, hospitalization data, postoperative complications (according to the Clavien–Dindo classification), and the need for surgical or radiological procedures.15
Quality of Life Assessment
Quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (V.3.0) and the EORTC QLQ-OV28 quality of life questionnaires before, and at 1, 3, 6, and 12 months after surgery. Patients who experienced recurrence stopped completing the quality of life questionnaires.16–18
Statistical Analysis
Data were summarized by frequency and percentage for categorical variables and by median (range) for continuous variables. Quality of life scores were presented before (initial) and at each follow-up visit after surgery (at 1, 3, 6, and 12 months) using median (range) values. Comparisons between groups were performed using the χ2 or Fisher’s exact test for categorical variables and the Mann–Whitney test for continuous variables. All reported P values were two sided. For all statistical tests, differences were considered significant at the 5% level. Statistical analyses were conducted using STATA 13 software (StataCorp, Texas, USA).
Results
A total of 148 patients were included in our study, 92 retrospectively and 56 prospectively (Figure 1). All patients had previously been treated with radiation therapy. Pelvic exenteration was performed for persistent or recurrent disease in 22.6% and 77.4% of patients, respectively. Among these, 70 patients underwent a urinary continent diversion and 78 patients a non-continent diversion. In those who underwent a continent diversion, 45 (30.4%, 45/148) had a Miami pouch, 23 (15.5%, 23/148) an Indiana pouch, and 2 (1.4%, 2/148) a Koch pouch. In those who underwent a non-continent diversion, in 74 (50%, 74/148) a urinary conduit was performed (66 patients underwent an ileal Bricker, 5 a colonic conduit, and 3 a jejunal Bricker) while 4 (2.7%, 4/148) patients underwent a bilateral cutaneous ureterostomy.
Flowchart of patient participation and study design. QoL, quality of life.
Median age at the primary diagnosis for the 148 patients was 50 years (range 24–78). Regarding medical comorbidities, 8.2% of patients were obese, 5.4% had diabetes mellitus, 23.8% had hypertension, and 6.1% had hypercholesterolemia. The most common primary tumor site was the cervix or the vagina in 126 (85.1%) patients and 98 (67.6%) patients had squamous cell carcinoma. There were no significant differences in baseline characteristics between patients with continent and non-continent urinary reconstruction. Patient characteristics are summarized in Table 1.
Patient characteristics
Median age at exenteration was 55 years (range 26–79). A total pelvic exenteration was performed in 76 (51.4%) patients and 72 (48.6%) patients underwent an anterior pelvic exenteration. In the non-continent group, 60.3% of patients underwent a total exenteration while in the continent group a total exenteration was performed in 41.4% of patients (P=0.02). Following the Magrina classification, 100 (68.5%) patients underwent a type I, 28 (19.2%) a type II, and 18 (12.3%) a type III exenteration (data were missing for 2 patients). There were no significant differences between the continent and incontinent groups. Vaginal reconstruction was performed in 70 (47.9%) patients, 39 patients in the continent group and 31 patients in the non-continent group, and in 90% of patients vaginal reconstruction was a myocutaneous flap (vertical rectus abdominis myocutaneous flap or gracilis myocutaneous flap).
Median length of hospitalization (including stoma education program) was 27 days (range 6–144) and 69.4% of patients where admitted to the intensive care unit during the immediate postoperative period. There were no significant differences between the two groups in hospitalization length or admission to the intensive care unit. Sixty-three patients developed a grade III–IV postoperative complication according to the Clavien–Dindo classification, 33 (42.3%) patients in the non-continent urinary diversion group and 30 patients in the continent group (42.9%) (P=0.95). Digestive and infectious complications were the most frequent overall (19.7% and 19.0%, respectively), with no significant differences between the two groups. In addition, there were no significant differences between the continent and non-continent groups regarding urinary complications (15.9% vs 16.7%, P=0.91). Among the 63 patients with a grade III–IV complication, 46 needed a surgical reintervention and 20 an interventional radiology procedure, with no significant differences between the continent and non-continent groups (Table 2).
Surgical data and postoperative outcomes
Quality of life was assessed in 56 patients included prospectively. The overall median global health and quality of life score was 58.3/100 just before surgery and 1 year after the intervention. No significant differences were found for any item in the quality of life questionnaires between patients with a continent and non-continent urinary reconstruction 1 year after surgery (Table 3). Regarding global quality of life (Figure 2A), 1 month after surgery, patients with a continent diversion had a lower median score (33.3/100) than patients with non-continent reconstruction (50/100). During follow-up, this difference was reversed, and 1 year after surgery, continent patients had a higher median score (62.5/100) than non-continent patients (58.3/100), but this difference was not significant. Regarding body image perception (Figure 2B), this was better in the non-continent group 1 month after surgery (66.7/100) compared with the continent group (50/100). However, 3 months after surgery, this difference was reversed, and body image median scores were 58.3/100 and 33.3/100 in the continent and non-continent groups, respectively. One year after surgery, body image median scores were 33.3/100 and 16.7/100 in the continent and non-continent group, respectively, but this difference was not significant.
(A) Global health and global quality of life evolution during the first year after pelvic exenteration and continent or non-continent urinary reconstruction. (B) Body image evolution during the first year after pelvic exenteration and continent or non-continent urinary reconstruction.
Quality of life from time of surgery at baseline, and at 1, 3, 6, and 12 months (n=56)
Discussion
In this study, we found that the rate of severe complications was similar in the continent and non-continent diversion groups (approximately 43%). In addition, the rate of severe complications requiring surgical reintervention and/or interventional radiology procedures was not significantly different between the two groups (approximately 30% and <15%, respectively). Regarding the type of complication, there were no significant differences between the groups. In the continent group, the most frequent complication was digestive and in the non-continent group it was infectious. In both groups, urinary complications were the second most common type. However, in the non-continent group, there was a significantly higher proportion of patients undergoing total pelvic exenteration, which carries a greater morbidity, and could have increased the complication rate due to the exenterative procedure in this group.
Pelvic exenteration has been associated with a high rate of postoperative complications, most likely increased by previous irradiation, estimated at approximately 40–50% for major complications and 80% for minor complications.19 This high morbidity remains an important concern. Recently, Lago et al published a retrospective study including patients who underwent pelvic exenteration with incontinent urinary and/or digestive reconstruction for gynecologic malignancies, and found a rate of grade III–IV complications according to the Clavien-Dindo classification of 48%, in line with our results. In agreement with our study, they observed a similar rate of urinary and digestive complications (approximately 17% and 26%, respectively).20 Four previous studies have compared the rate of complications between continent and incontinent urinary diversion in patients with gynecologic cancers. Age and patient baseline characteristics were comparable with our patients. None of these four studies found significant differences in postoperative complications.9–12 However, Urh et al reported a higher risk of stone formation in patients undergoing continent reconstruction (34.8% vs 2.3%, P=0.001).9 It is now well established that the use of automatic non-absorbable staplers is associated with an increased risk of stone formation13; for this reason, absorbable staples should be used when performing a continent urinary diversion.14 Houvenaeghel et al described a non-significant higher rate of overall postoperative 12 week surgical complications in the incontinent diversion group compared with the continent group (12.9% and 6.25%, respectively).10 These last two studies reported a higher rate of severe urinary complications than our study (approximately 30–40% compared with 16% in our study).9 10 Ramirez et al found that infection was the most frequent complication after pelvic exenteration with the Miami pouch continent urinary reconstruction, with a rate of 35%, twice the rate reported in our study.13
Some factors have been related to an increased rate of postoperative complications after pelvic exenteration. Nahar et al found that urinary diversion after radical cystectomy for bladder cancer performed at a non-academic center was an independent predictor of 30 day readmission (odds ratio 1.19, P=0.010) and was associated with a higher rate of 30 day mortality (odds ratio 1.27, P=0.043).21 In our multicenter study, all patients were included in the referral academic centers and this could explain our acceptable rate of severe postoperative complications after these high level salvage procedures. In another study, Leow et al showed that there was an inverse relationship between the volume of surgeries per surgeon and the occurrence of 90 day postoperative major complications.22 For these reasons, urologic international recommendations are to perform these types of procedures exclusively in high volume hospitals with 40–50 cases per year.23 However, none of the centers included in our study performed these numbers of procedures per year for gynecologic malignancies.
Quality of Life Assessment
We did not find significant differences between the two groups regarding quality of life 1 year after surgery for any of the items evaluated by the questionnaires. However, we observed lower median scores in global health and global quality of life scores in the continent diversion group 1 month after surgery. One year after surgery, this difference was reversed, and the median scores were higher in the continent group. Nevertheless, this difference was not significant. Regarding body image perception, the continent group attained the highest median score later than the non-continent group (58.3/100 at 3 months vs 66.7/100 at 1 month). One year after surgery, the continent group maintained higher scores than the incontinent group, although the difference was not significant. A possible explanation for the initially lower median scores in global health, quality of life, and body image in the continent group may be the learning process of self-catherization, which can be very difficult for half of the patients, as reported in other studies.12 The higher median scores, even if not significant, 1 year after surgery in the continent diversion group may be explained by the absence of ostomies in patients undergoing a continent urinary reconstruction after pelvic exenteration.
Controversial results can be found in the literature regarding quality of life after continent and non-continent urinary reconstruction. Recently, Ziouziou et al performed a meta-analysis including four studies which compared the health related quality of life between the Bricker procedure—a non-continent diversion—and continent orthotopic neobladder in patients undergoing an anterior pelvic exenteration for bladder cancer. The results demonstrated better urinary function and urinary bother scores in the non-continent diversion group (urinary function scores referring to the frequency of these symptoms, and urinary bother scores referring to the individual perception of these symptoms). In contrast, sexual function was significantly better in orthotopic neobladder patients. However, among these four studies, only one evaluated quality of life prospectively, and all used the Bladder Cancer Index to assess quality of life which is a non-validated tool for this purpose.24 Conversely, Dessole et al assessed quality of life in 96 patients undergoing a pelvic exenteration with urinary reconstruction for gynecological cancer. It was a retrospective, multicenter study that showed that non-continent urinary reconstruction was an independent predictor of poorer global health status scores and lower body image.25 A review from the International Consultation on Urological Diseases stated that there was no evidence of a better quality of life when a continent reconstruction was performed after radical cystectomy instead of a conduit diversion in patients with bladder cancer.26 In our series, 47% of patients underwent vaginal reconstruction with similar rates in the continent and non-continent groups. This type of reconstruction may positively impact on the patient's quality of life, body image perception, and sexuality.8 Parameters such as comorbidities, previous surgical and radiation history, obesity, baseline renal and hepatic function, sexual function, and ability to self-catheterize should be considered in the choice of urinary diversion.2
The main strengths of our study are its multicenter design, comprising 10 referral academic centers, and the large number of patients (n=148), which is particularly interesting as pelvic exenteration is not a frequent procedure. One of the limitations of our study may be that we assessed quality of life in only 56 patients, as the remaining 92 patients were included retrospectively. This low number of patients may be the reason why we did not find significant differences between the groups. Nevertheless, pelvic exenteration in gynecologic malignancies is a salvage procedure, and therefore it is not frequently performed. Another limitation could be that complications were not chronologically classified as early and late, which would have been relevant in the assessment of postoperative morbidity. To our knowledge, this is the only study comparing both complication rate and quality of life between patients undergoing continent and non-continent urinary reconstructions after a pelvic exenteration for gynecologic cancers. We believe that pelvic exenteration and reconstructive procedures are very complex interventions needing high level surgical skills. It usually involves complex vaginal reconstruction with myocutaneous and perforator flaps3 27 as well as anorectal, perineal, and vascular reconstructions.14 For this reason, all patients requiring this type of salvage surgery should be referred to high volume centers with multidisciplinary teams.28 This would allow patients to have several options for reconstructive techniques. Currently, there is a trend towards functioning and anatomic reconstructions, such as orthotopic neobladder. However, improvement in quality of life in these patients has yet to be evaluated.
In summary, continent and non-continent urinary diversions after pelvic exenteration for gynecologic malignancies seem to be equivalent in terms of severe postoperative complications and quality of life, even though there was a trend towards better long term quality of life in patients with continent urinary reconstructions. The choice of urinary reconstruction should be based on the surgeon's experience and the patient's preference.
References
Footnotes
MAA and EM are joint first authors.
AM and GF are joint senior authors.
Twitter @AngelesFite, @Alejandra
Contributors MAA: conceptualization, data curation, methodology, and writing–original draft. EM: conceptualization, data curation, methodology, and writing–original draft. PR: conceptualization, project administration, and methodology writing–review. BC: conceptualization, data curation, methodology, statistical analyses, and writing–review. PM: conceptualization, project administration, and methodology writing–review. EL: conceptualization, project administration, and methodology writing–review. FF: conceptualization, project administration, and methodology writing– review. FN: conceptualization, project administration, and methodology writing–review. CL: conceptualization, project administration, and methodology writing–review. SG: conceptualization, project administration, and methodology writing– review. FG: conceptualization, project administration, and methodology writing–review. FM: conceptualization, project administration, and methodology writing–review. LG: conceptualization, project administration, and methodology writing– review. CM-G: conceptualization, data curation, methodology, and writing–original draft. FM: conceptualization, data curation, methodology, and writing–original draft. AM: conceptualization, project administration, and methodology writing–review. GF: conceptualization, project administration, and methodology writing– review.
Funding This study was supported by a grant from the French Ministry of Health (STIC (support for innovative and expensive techniques), 2007, Exenteration pelvienne).
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval Institutional review board approval was obtained from all centers.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.