Incidence and risk factors of bladder injuries during laparoscopic hysterectomy indicated for benign uterine pathologies: a 14.5 years experience in a continuous series of 1501 procedures

Human Reproduction, Apr 2009

Laparoscopic hysterectomy is indicated as an alternative to laparotomy when the vaginal route is potentially difficult because of an immobile uterus and a poor vaginal accessibility. The aim of this study was to evaluate the rate, the risk factors for bladder injuries in a series of 1501 laparoscopic hysterectomies indicated for benign uterine pathologies.

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Incidence and risk factors of bladder injuries during laparoscopic hysterectomy indicated for benign uterine pathologies: a 14.5 years experience in a continuous series of 1501 procedures

Advanced Access publication on January Incidence and risk factors of bladder injuries during laparoscopic hysterectomy indicated for benign uterine pathologies: a 14.5 years experience in a continuous series of 1501 procedures Marie-Christine Lafay Pillet 2 Franck Leonard 2 Nicolas Chopin 2 Jean-Marie Malaret 2 Bruno Borghese 0 1 2 Herve´ Foulot 2 Adolphe Fotso 2 Charles Chapron 0 1 2 0 INSERM, Unite ́ de Recherche U567 , Paris , France 1 Institut Cochin, Universite ́ Paris Descartes, CNRS (UMR 8104) , Paris , France 2 Universite ́ Paris Descartes, Faculte ́ de Me ́decine, Assistance Publique-Hoˆ pitaux de Paris (AP-HP), Groupe Hospitalier Universitaire (GHU) Ouest, Centre Hospitalier Universitaire (CHU) Cochin Saint Vincent de Paul, Service de Gyne ́cologie Obste ́trique II et Me ́decine de la Reproduction (Professor Chapron) , Paris , France background: Laparoscopic hysterectomy is indicated as an alternative to laparotomy when the vaginal route is potentially difficult because of an immobile uterus and a poor vaginal accessibility. The aim of this study was to evaluate the rate, the risk factors for bladder injuries in a series of 1501 laparoscopic hysterectomies indicated for benign uterine pathologies. methods: This study was conducted retrospectively from January 1993 to 2000 and prospectively from 2001 to July 2007.The indications, patients' characteristics and complications were recorded. The overall rate of bladder injuries, the comparison of means (t test) and percentages (exact x2 test) between the cases and the population with no injury, the odd ratios (OR) and multivariate analysis were performed using the statistical package for the social sciences software. results: The rate of bladder injuries was 1% (15 patients). Risks factors were previous Caesarian section [OR: 4.33, 95% confidence interval (CI): 1.53 - 12.30] and previous laparotomy (OR: 4.69, 95% CI: 1.59 - 13.8). The rate of injury decreases with the surgeons' experience and reaches a plateau of 0.4% after 100 hysterectomies performed. conclusions: The rate of bladder injury during total laparoscopic hysterectomy is low and decreases with the surgeon's experience. Bladder injury is not linked to an increase of post-operative morbidity when recognized and repaired during the same laparoscopic procedure. The comparison with other routes of hysterectomies should take into account these risk factors. total hysterectomy / operative laparoscopy / laparoscopic hysterectomy / complications / bladder injuries Introduction Total hysterectomy for benign lesions is one of the more frequent surgeries in women (Merrill et al., 2008) . Reich (1989) reported the first case of total laparoscopic hysterectomy (TLH) in 1989. Laparoscopic hysterectomy is indicated as an alternative to laparotomy when the vaginal route is potentially difficult because of an immobile uterus or a poor vaginal accessibility (Chapron et al., 1995) . Most hysterectomies are done by laparotomy but the rate of hysterectomies performed by laparoscopy is increasing regularly these last years (Chapron et al., 1999; Farquhar and Steiner, 2002; David-Montefiore et al., 2007; Istre et al., 2007) . The benefit of laparoscopy compared with laparotomy is actually well known (Kovac, 2000; Garry et al., 2004; Johnson et al., 2005; Falcone et al., 1999) . Even if a meta-analysis demonstrated that laparoscopy is not inherently dangerous (Chapron et al., 2002) , one of the risks attributed to laparoscopic approach is the increased risk of urologic complications (Meikle et al., 1997; Harkki-Siren et al., 1998; Garry et al., 2004; Johnson et al., 2005) upon which bladder injuries are the most frequent (Makinen et al., 2001). Incidence of bladder injuries is linked to anatomic considerations as total hysterectomy needs vesico-uterin pouch dissection, when a bladder injury may occur. The aim of the study was to evaluate the rate of bladder injuries during TLH on a large prospective monocentric observational study and to analyse the risk factors of this complication. Patients and Methods All patients having a TLH performed between January 1993 and July 2007 for any pathology except cancer, genital prolapse and urinary incontinence have been included in the study. All hysterectomies have been performed according to a previously described procedure (Chapron et al., 1994) : the first step is the bipolar coagulation then the section of adnexal pedicules followed by the dissection of the uterovesical pouch, the bipolar coagulation of uterine pedicules, the coagulation of the cervico-vaginal vessels, the bipolar coagulation then section of utero-sacral ligaments. Then the last step is the opening of the vagina on the anterior circumference and once the peritoneum had dropped, the patient is placed in the gynecologic position, the vaginal incision is terminated and the uterus extracted. The main characteristics of hysterectomy were as follows: (i) in all cases hysterectomy was total (subtotal hysterectomies were excluded) indicated for a benign pathology; (ii) hemostasis was performed using bipolar coagulation and (iii) all procedures were done using conventional disposable instruments (Karl Storz Endoskope, Tutlingen, Germany). During the study period, medical, operative and pathological reports were collected for each patient. Between January 1993 and December 2000, data were collected retrospectively (711 cases). Since January 2001 to July 2007, the same data collection was performed prospectively (790 cases). For each patient the following criteria were analysed and collected into a data base (Leonard et al., 2007) : (i) patients’ characteristics: age, height, weight, BMI, gravidity, parity, menopausal status, pre-operative transvaginal ultrasonographic uterus measures, indication for total hysterectomy, previous history of vaginal delivery, Cesarean section (CS) and adhesiogenous abdomino-pelvic surgery (Leonard et al., 2005) ; (ii) operative and post-operative results: operative time, hospital stay, uterine weight, associated surgical procedures (adhesiolysis, uterine morcellation, adnexectomy and endometriosis), conversion, complications, re-hospitalization and (iii)bladder injuries: cases, diagnosis modality, treatment modalities and sequels. Statistical method The comparison of prospective and retrospective data showed no significant statistical differences for the general characteristics of the two populations (age, parity, menopausal status, uterine weight, etc.) except a higher BMI in the prospective part (Table I). Despite an expected nonsignificant underestimation of some parameters in the retrospective data and under-reporting of some minor post-operative complications compared with the prospective data (Table II), they did not affect the significant variables, so data were pooled and analysed together. The overall rate of bladder injuries was computed. The means of the two populations with and with no bladder injury have been compared using t test and analysis of variance and percentages using exact x2 test or Fisher’s exact test when the assumptions for x2 distribution were violated. The Kruskall – Wallis test was used to compare several groups of non-parametrical data; for predictive variables the odd ratios (OR) were calculated. A P-value of less than 0.05 was considered as statistically significant. A discriminant analysis was used when applicable with a stepwise technique introducing significant variables to identify those contributing to the model. All the statistics were done using the statistical package for the social sciences statistical analysis program system [SPSS for windows release 14.0.1 (7 December 2005) Chicago SPSS Inc.]. Results During the study period, 1501 patients underwent a laparoscopic hysterectomy. Patients’ characteristics and indications for surgery are detailed in Table I for the total population, the retrospective and prospective part. The rate of bladder injuries was 1% (15 cases). The pre-operative patients’ characteristics according to the existence or non-existence of a bladder injury are reported in Table III. There was no association with menopausal status, BMI, gravidity, parity, uterus size, uterus weight and patients with bladder injuries were statistically younger (44 + 2.8 versus 48 + 6.8 years). The pre-operative factors significantly associated with bladder injury are the following: previous laparotomy [446 (30%) versus 10 patients (67%); OR: 4.69, 95% confidence interval (CI): 1.59 – 13.8]; previous adhesiogenous abdominopelvic surgery [375 (25%) versus 8 patients (53%); OR: 3.4, 95% CI: 1.23– 9.45]; previous CS [199 (13%) versus 6 patients (40%); OR: 4.33, 95% CI: 1.53– 12.30); mean number of previous CS (0.19 + 0.55 versus 0.73 + 1, P , 0.0001) and no previous vaginal delivery [550 (37%) versus 10 patients (67%); OR: 3.43, 95% CI: 1.16 – 10]. The discriminant analysis with step-by-step introduction of the significant variables shows that previous CS is the most important factor influencing the onset of a bladder injury followed by previous laparotomy. No previous vaginal delivery and previous adhesiogenous abdominopelvic surgery did not contribute significantly to the model. For patients who had one CS, the percentage of bladder injuries is 1.4%, and for those who had more than one is 7%. The nonparametric Kruskall – Wallis test comparing the incidence of bladder injury between groups of patients having one, two or three or more CS is statistically significant (P , 0.001) indicating that the risk increases with the number of previous CS. Per and post-operative patient’s characteristics according to the occurrence or not of bladder injury are reported in Table IV: in case of bladder injury, the mean time in the operating room is 78 min longer [131 + 44 (35 – 350) versus 209 + 84 (90 – 420), P , 0.003] and the mean length of uncomplicated surgery is 124 + 39 min (range 35 – 350). The rate of laparo conversion is significantly higher as three laparotomies have been done to repair bladder injuries. The diagnosis of bladder injury is done peroperatively in all cases; no bladder injury was unknown at the time of surgery. Another surgical-associated procedure such as adnexectomy, adhesiolysis, myomectomy or endometriosis does not increase the risk. The length of hospital stay increased significantly from a mean of 3.5 + 1 to 5.7 + 2 days. There was no increase of urinary infection, and no significant decrease in hemoglobin level. There was one hematoma, one fever above 388C, one vesico-vaginal fistula, which needed a bladder catheter for 1 month. . . e . . u . la ... 70 60 12 10 41 -v .. S .0 S .0 S S S S S .0 S .0 .0 S P .. N 0 N 0 N N N N N 0 N 0 0 N . . . . . . . . ) . . 0 ) .. 9 ) 4 ) Among the 15 patients with a bladder injury, 11 patients had at least two risks factors, 2 had at least one risk factor and 2 had none but were operated by a junior surgeon and had an oversized uterus. All bladder injuries were diagnosed during surgery and only three were treated by laparotomy at the beginning of the surgeons’ experience. Neither severe post-operative complications nor sequels were noticed after management of bladder injuries. We looked at the learning curve concerning bladder injury: 19 surgeons participated in the study, 7 have done more than 30 procedures, 4 more than 50, 3 more than 100 and 2 more than 200. The rate of bladder injures was 1.9% during the first 40 procedures of all surgeons, 1.5% on the following 60 procedures and 0.4% after 100 procedures performed showing a decrease of the percentage of bladder injuries as the number of hysterectomies performed by each surgeon increases (Fig. 1). Discussion The rate of bladder injuries on the series of 1501 TLH is 1%. These results are in agreement with those of most other series (Table V). Some authors claimed that urinary tract injuries, especially bladder injuries, appear to be more frequent by laparoscopy (Harkki-Siren et al., 1998; Makinen et al., 2001) . Johnson published a meta-analysis of prospective randomized trials including 16 trials comparing abdominal and laparoscopic routes, 4 comparing vaginal and laparoscopic routes, 1 laparoscopic-assisted vaginal hysterectomy with TLH, 1 laparoscopic with vaginal and abdominal and 3 comparing the three routes of hysterectomies. The rate of urinary complications looks higher with laparoscopy even if the difference in rate of bladder and ureter injuries alone was not statistically significant (Johnson et al., 2005). Garry et al. Figure 1 Cumulative number and percentage of bladder injuries according to the total number of hysterectomies per surgeon. (2004) in a randomized prospective trial compared in one arm the vaginal and the laparoscopic routes and in the other arm laparotomy and laparoscopy excluding the learning phase (more than 25 procedures) and large uteri (more than 12 weeks’ gestation size). He found 1% rate of bladder injuries for laparotomy compared with 2.1% for laparoscopy and in the second arm a 1.2% rate for vaginal route compared with 0.9% for laparoscopy, but he noticed that in the first arm there were significantly more nulliparous, past history of CS and endometriosis and unfortunately the number of hysterectomies in the second arm was too small to conclude (Garry et al., 2004) . However, the comparison of complication rate between the different routes of hysterectomy needs to take into account the bladder injury risk factors. The incidence of risks factors is not regularly distributed in the different routes of surgery. Previous laparotomies and previous deliveries by CS influence the surgeon’s choice for the route of hysterectomy: this is a bias of selection which can obviously influences the results. In particular, this could explain why there are more risk factors for the laparoscopic approach than for the vaginal route. In our series the main risk factors are previous CS and previous laparotomy. No previous vaginal delivery and adhesiogenous surgery can also increase the risk if associated. Risk factor, such as previous CS, has already been shown for the vaginal route (Mathevet et al., 2001; Boukerrou et al., 2004) and laparotomy (Carley et al., 2002). Pelvic adhesions (OR of 1.7) and previous CS (OR of 1.9) have been shown to be significant risk factors for bladder injury during hysterectomy when the route of hysterectomy have been considered as feasible by vaginal, abdominal or laparoscopic route (Davies et al., 2002) . Rooney et al. (2005) analysed 51 bladder injuries in a case – control study where each case was matched for age, type of hysterectomy, adhesiolysis, prolapse surgery, incontinence surgery, adhesiolysis to three patients having hysterectomy and no bladder injury: the cystostomy OR for CS was 2.04 (95% CI: 1.2 – 3.5). All these results show that risk factors exist independently of the route of hysterectomies, but in most series they are not equally distributed in the three modes of hysterectomies. The comparison is then impossible unless the risk factors are previously controlled. We show in our series that the incidence of bladder injury decreases with the surgeon’s experience. The analysis of a large retrospective data set (Wattiez et al., 2002) shows that the rate of bladder injury decreases from 2.3% on the first 952 cases to 0.9% on the following 695 cases. Also, a large prospective study of 10 110 hysterectomies in 1996 in Norway gives a higher percentage of bladder injuries for laparoscopic hysterectomies, which reaches 1.3%, but decreases from 2% for the first 30 procedures to 0.8% after the first 30 procedures (Makinen et al., 2001) . These results are in agreement with our rate of almost 2% in the first 40 procedures of all surgeons and the rate of 0.4% for the hysterectomies performed after 100 cases of the surgeons’ experience. This could also explain why data including the learning phase of surgeons show a higher incidence than the more classical approaches, and these rates should decrease with the experience of the surgeons. Data on 929 TLH show a decrease in overall complications from 4% in the first 40 cases to 0.5% in the next 30 cases (Altgassen et al., 2004) . Kreiker et al. (2004) show that the duration of surgery decreases significantly after 80 procedures. In Table V, one can see that most reports of large cohorts of procedures performed between 1989 and 2000 give a rate of injuries above 1.5% as more recent cohorts after 2000 show a rate of less than 1%; this rate is similar and sometimes lower than vaginal and abdominal hysterectomies (Vakili et al., 2005; David-Montefiore et al., 2007; Garry et al., 2004) . It is too early to conclude that the laparoscopic approach could decrease the rate of this specific complication, but this is a reasonable hypothesis which could be validated soon. We can already conclude that the rate of bladder injuries when the learning curve is excluded and when the risk factors are controlled does not look higher for TLH. The diagnosis of bladder injury in our cases has always been made during the procedure. It is important that the diagnosis should be done per-operatively to avoid re-intervention and re-admission, which increase the cost and the morbidity. Cases of unknown complications at the time of surgery have been reported as high as 42% (Harkki-Siren et al., 1998) or 47% (Ostrzenski and Ostrzenska, 1998) . Vakili et al. (2005) gives a rate of only 35% of diagnosis before cystoscopy done systematically at the end of the procedure and conclude that it should be performed more widely. A review of articles found that the rate of bladder injuries reported after hysterectomies is higher if a cystoscopy is systematically performed at the end of surgery (Gilmour et al., 2006) . To prevent bladder injures we perform a very careful dissection of the vesico-vaginal pouch and use a simple uterine canulation; we don not use, as other teams do, a specific uterine manipulator (Wattiez et al., 2002) . Uterine canulation associated with a vaginal packing of the anterior cul de sac allows the assistant pushing the uterus in the direction of the promontory to facilitate the dissection between the anterior wall of the vagina and the bladder. In case of difficult dissection, such as previous surgery (CS, endometriosis, conization, etc.), it is possible to visualize the limits of the bladder by filling it through the catheter with a methylene blue dye solution. This should be done systematically at the end of the procedure to avoid unknown injury. Hemostasis by bipolar coagulation in the vesico-vaginal space should be done carefully. Some bladder injuries have been described when introducing trocards, the safety rules of introduction have to be followed, in particular avoiding the Pfannenstiel scar in case of previous laparotomy. Vaginal hysterectomy is still a first choice for most surgeons and we do not discuss that point here. This study is not a comparison with the vaginal route but the data show that we have to re-evaluate the laparoscopic technique as our experience increases especially for parameters like operative time, urinary tract complications and the decreasing percentage of hysterectomies done by laprotomy so that the comparison with vaginal route could be more accurate. The strength of present study lies in the large number of unselected cases with the same technique used by all surgeons. Further large prospective studies are necessary to confirm the risk factors and achieve the comparison with other routes of hysterectomy. Conclusion The rate of bladder injuries is low and decreases with the surgeon’s experience. This complication has a low morbidity especially if the diagnosis is performed at the time of surgery and the bladder repaired laparoscopically. Better knowledge of risk factors as we showed in this study, in particular previous CS and previous laparotomy, can avoid some bladder injuries as the surgeon is more careful in the dissection of the vesico-vaginal pouch and performs a blue methylene dye instillation test for diagnosis and repair of the injury during the surgical procedure. These risk factors are shared with all types of hysterectomies. When risks factors are controlled the rate of bladder injury during TLH is not increased. Urologic complications, which have been considered by many authors as more frequent in TLH, have to be re-evaluated on the basis of new prospective studies taking into account the learning curve and the risk factors. Altgassen C , Michels W , Schneider A . Learning laparoscopic-assisted hysterectomy . Obstet Gynecol 2004 ; 104 : 308 - 313 . Boukerrou M , Lambaudie E , Collinet P , Crepin G , Cosson M. [ Previous caesarean section is an operative risk factor in vaginal hysterectomy] . 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Lafay Pillet, Marie-Christine, Leonard, Franck, Chopin, Nicolas, Malaret, Jean-Marie, Borghese, Bruno, Foulot, Hervé, Fotso, Adolphe, Chapron, Charles. Incidence and risk factors of bladder injuries during laparoscopic hysterectomy indicated for benign uterine pathologies: a 14.5 years experience in a continuous series of 1501 procedures, Human Reproduction, 2009, 842-849, DOI: 10.1093/humrep/den467