Uccella, Stefano MD; Ceccaroni, Marcello MD; Cromi, Antonella MD, PhD; Malzoni, Mario MD; Berretta, Roberto MD, PhD; De Iaco, Pierandrea MD; Roviglione, Giovanni MD; Bogani, Giorgio MD; Minelli, Luca MD; Ghezzi, Fabio MD
Although rare, vaginal cuff dehiscence can represent an extremely serious postoperative complication of hysterectomy, with potential heavy morbidity for the patients. When it is associated with partial or total evisceration, peritonitis, sepsis, or acute mesenteric ischemia can develop and bowel resection may be necessary.1 Major risk factors for its occurrence include vaginal atrophy, radiation therapy, precocious resume of coital activity, and postoperative infectious morbidity, but the majority of cuff separations occur without any identifiable predisposing condition.2–5
Parallel to the wide implementation of minimally invasive techniques, an increased interest in the incidence of vaginal cuff dehiscence has been observed. Recent studies suggest that the rate of vaginal cuff dehiscence is heavily influenced by the route of hysterectomy, with laparoscopic and robotic hysterectomy being associated with a higher rate of vault complications compared with open abdominal and vaginal procedures.1,3,6,7
Several conditions may play a role in the development of cuff separation among women who undergo endoscopic hysterectomy. The most advocated factors include vaginal tissue damage attributable to monopolar and bipolar cauterization, and also the inclusion of an insufficient amount of tissue during suture attributable to the magnified view of the laparoscope.3,7 Regrettably, little research has been conducted to investigate the etiology of vaginal dehiscence after minimally invasive hysterectomy, so that any possible explanation remains elusive.
A recent systematic review analyzing data from more than 13,000 total endoscopic (both laparoscopic and robotic) hysterectomies included in series published between 1989 and 2010, suggests that the modality of cuff closure may play a key role in the genesis of vaginal cuff dehiscence, with transvaginal suture being associated with threefold and ninefold reductions in the incidence of cuff separations compared with laparoscopic and robotic sutures, respectively.8
The aim of the present retrospective study has been to investigate how different approaches to hysterectomy may influence the risk of development of vaginal cuff dehiscence in a large multi-institutional series. We also stratified total laparoscopic hysterectomies by the route of vaginal cuff closure (laparoscopic compared with transvaginal suture). Finally, we analyzed the use of monopolar energy at the time of colpotomy to identify its possible role in the genesis of vaginal separations.
MATERIALS AND METHODS
A review of consecutive women who underwent hysterectomy with or without bilateral salpingo-ophorectomy for gynecologic disease between January 1994 and December 2008, was performed in six Italian gynecology departments: 1) University of Insubria, Varese; 2) Del Ponte Hospital, Varese; 3) Sacred Heart Hospital, Negrar, Verona; 4) University of Parma, Parma; 5) Malzoni Medical Center, Avellino; and 6) Bologna University Hospital, Bologna.
Institutional review board approval was obtained at each institution and all considered patients gave their written consent for the use of personal information for health research in each surgical center. Patients' characteristics, details of surgical procedures, surgical outcomes, and follow-up evaluations for each woman were abstracted from the different institutional databases. These research-quality data sets contain data on surgical procedures conducted at each institution are maintained by trained residents under consultants' supervision and are regularly updated at each institution. Patients who underwent laparoscopy-assisted vaginal hysterectomy, radical hysterectomy, or supracervical hysterectomy were excluded from the present analysis. A part of the women included in the present analysis has been the object of previously published investigations.1,8
The different types of hysterectomy were performed after the classical surgical technique in all the participating centers. In particular, abdominal hysterectomy and vaginal hysterectomy were inspired by previously reported standard descriptions.9,10 It was the policy of all the participating centers to perform colpotomy with cold knife in all cases of vaginal hysterectomy. Conversely, monopolar energy or cold knife was used to incise the vagina in case of abdominal hysterectomy, on the basis of surgeon's preference as well as institutional policy. Two methods for vaginal cuff closure were used at the end of abdominal hysterectomy and vaginal hysterectomy, according to surgeon's choice and different institutional policies: 1) unclosed peritoneum, in which two angular stitches were placed at the vaginal angles and the vagina was sutured with either interrupted stitches or a running suture; or 2) closed peritoneum, in which the cuff's margins were sutured with a running interlocking suture, leaving the vaginal epithelium open, before peritoneal running suture.
Regarding total laparoscopic hysterectomy, the details of the techniques used in the different centers have been previously presented elsewhere.11,12 A uterine manipulator was always used. The uterus was entirely detached from the pelvic supportive structures by laparoscopy. Colpotomy was performed laparoscopically in all cases with monopolar energy, after exposure of the vaginal fornices, consequent to cranial traction of the uterus using the uterine manipulator. The standard surgical set-up included that power used for monopolar colpotomy was set at 50 watts in four of the participating centers and at 60 watts in the remaining two centers; the “cut” (rather than “coagulation”) modality was used to incise the vagina at all the participating institutions. It is a strict policy of all the centers involved that the set-up of the instruments is checked by the surgeons before each operation. Data regarding the power at which colpotomy was performed during total laparoscopic hysterectomy were not directly collected in the database; however, given our rigorous surgical policies, we assumed (for the purposes of the present analysis) that the power was set at 50 or 60 watts in each case according to the surgical center in which the operation was performed. Vaginal cuff closure was performed either laparoscopically (using intracorporeal or extracorporeal knots) or transvaginally. The technique for laparoscopic closure consisted of two running sutures with braided and coated 0-polyglycolic material placed from lateral angles to the midline of the cuff. Transvaginal closure at the end of total laparoscopic hysterectomy was performed with a single-layer technique using a running braided and coated 0-polyglactin suture.8 A closed suction drainage was applied in the abdominal cavity only when the surgeon suspected inadequate hemostasis at the end of surgery.
The first postoperative follow-up visit was scheduled between 1 and 3 months after the operation and all patients were strongly advised to return in case of any symptom possibly related to the operation, such as fever, vaginal discharge, vaginal bleeding, herniation of organs through the vagina, pelvic discomfort, abdominal pain, or constipation. We advised women to avoid vaginal intercourses for at least 1 month, particularly in women at high risk for wound-healing problems (eg, diabetes mellitus, connective tissue disorders). Women were not included in the present analysis if they did not achieve at least 24 months of telephone or clinical follow-up. Clinical evaluation for patients who underwent surgery for malignant disease was scheduled every 3–4 months for the first 2 years, then every 6 months for the first 5 years, and annually thereafter.
Data of each vaginal cuff dehiscence were recorded. Cuff dehiscence was defined as partial or complete separation of the vaginal vault with or without intra-abdominal organ evisceration. We analyzed the incidence and risk factor of the cases of vaginal dehiscence, and we also examined trigger events, time of onset, and the surgical technique for vault repair, when needed.
Statistical analysis was performed with GraphPad Prism 5.00 for Windows. Data expressed as percentages were analyzed for statistical significance using the χ2 (and Fisher exact) test. P<.05 was considered statistically significant. For percentages, not only a point estimate but also 95% confidence intervals (CIs) were provided. Odds ratios (ORs) and 95% CIs were calculated for each comparison. Normality testing (D'Agostino and Pearson test) was performed to determine whether data were sampled from a Gaussian distribution. The t test and Mann-Whitney U test were used to compare variables sampled from Gaussian and non-Gaussian distributions, respectively.
A total of 12,398 hysterectomies were included in the present study: 3,573 (28.8%), 4,291 (34.6%), and 4,534 (36.6%) patients underwent total laparoscopic, abdominal, and vaginal hysterectomy, respectively. Overall, a total of 38 (0.3%, 95% CI 0.21%–0.41%) vaginal cuff dehiscence occurred: 23 (0.64%, 95% CI 0.43–0.96%) cuff separations were observed among women who underwent total laparoscopic hysterectomy, 9 (0.21%, 95% CI 0.10–0.38%) among women who underwent total abdominal hysterectomy, and 6 (0.13%, 95% CI 0.05%–0.27%) among women who had vaginal hysterectomy. The incidence of vaginal cuff dehiscence was significantly higher in the laparoscopic group compared with abdominal hysterectomy group (P=.003; OR 3.0, 95% CI 1.4–6.6) and vaginal hysterectomy group (P<.001, OR 4.90, 95% CI 2.00–12.06).
Overall, closing or not closing the peritoneum at the end of abdominal hysterectomy or vaginal hysterectomy did not influence the risk of dehiscence: 2 out of 1,295 (0.15%, 95% CI 0.05–0.56%) women who had closure of the peritoneum with vaginal epithelium left open experienced a dehiscence compared with 13 out of 7,530 (0.17%, 95% CI 0.09–0.28%) patients in whom the peritoneum was left unclosed (P=.88, OR 0.89, 95% CI 0.20–3.97).
Median time to the occurrence of cuff separation after total laparoscopic hysterectomy, abdominal hysterectomy, and vaginal hysterectomy was 1 month (range 1–12), 5 months (range 2–48), and 24 months (range 1–62), respectively. Dehiscence after endoscopic hysterectomy occurred earlier than after abdominal hysterectomy (P=.004) and vaginal hysterectomy (P=.009). A similar onset time was observed if comparing abdominal hysterectomy and vaginal hysterectomy (P=.55). Details of cuff dehiscence after different routes of hysterectomy are listed in Table 1. Indication for hysterectomy did not influence the rate of cuff separation: 28 of 10,296 (0.27%, 95% CI 0.18–0.39%) and 10 of 2,102 (0.47%, 95% CI, 0.26%–0.87%) dehiscences were observed in cases of benign pathology and malignant disease, respectively (P=.12). However, when the analysis was restricted to the patients who underwent laparoscopy, 6 of 448 (1.33%, 95% CI 0.52%–2.71%) and 17 of 3,125 (0.5%, 95% CI 0.32%–0.85%) dehiscences were registered after the surgical management of malignant and benign disease, respectively, with a tendency toward significance (P=.098, OR 2.48, 95% CI 0.96–6.33).
Among patients who underwent total laparoscopic hysterectomy, vaginal suture was performed laparoscopically and vaginally in 2,332 (65.2%) and 1,241 (34.8%) cases, respectively. Laparoscopic closure was associated with a higher rate of cuff separations than transvaginal suture (20 of 2,332: 0.86% [95% CI 0.53–1.29%] compared with 3 of 1,241: 0.24% [95% CI 0.06–0.64%], P=.028, OR 3.5, 95% CI, 1.06–12.04). Comparing women who had total laparoscopic hysterectomy with transvaginal closure with women who underwent abdominal hysterectomy or vaginal hysterectomy, the risk of dehiscence was similar: 0.24% compared with 0.21% (P=.83, OR 1.15, 95% CI 0.31–4.27) for total laparoscopic hysterectomy with transvaginal suture compared with abdominal hysterectomy, and 0.24% compared with 0.13% (P=.39, OR 1.83, 95% CI 0.46–7.33) for total laparoscopic hysterectomy with transvaginal closure compared with vaginal hysterectomy. Table 2 summarizes the incidence of vaginal cuff dehiscence stratified by different routes of hysterectomy and modes of vaginal closure. Figure 1 reports the decreasing incidence of dehiscence from total laparoscopic hysterectomy with laparoscopic closure to vaginal hysterectomy through total laparoscopic hysterectomy (all types of vaginal closure), total laparoscopic hysterectomy with transvaginal closure, and abdominal hysterectomy.
No difference in terms of risk of cuff separation was observed if colpotomy was performed with monopolar energy or with cold knife in the abdominal hysterectomy group (8 of 3,430 [0.23%] compared with 1 of 861 [0.12%], respectively; P=.80, OR 2.01, 95% CI 0.25–16.1).
Regarding the power of monopolar energy utilized for colpotomy at the end of total laparoscopic hysterectomy, the use of lower power did not appear to protect from the risk of vaginal cuff dehiscence; in fact, a total of 2 of 413 (0.48%) dehiscence occurrences were observed when transvaginal cuff suture at the end of total laparoscopic hysterectomy was performed in centers in which a power of 50 watts is used compared with 1 of 828 (0.12%) when a power of 60 watts was used (P=.26, OR 4.02, 95% CI 0.36–44.5).
Twenty-four out of 38 (63.2%) intra-abdominal organ eviscerations occurred after vaginal vault separations. Intra-abdominal organ resection was needed in seven of these 24 cases (29.2%) because of ischemia of the prolapsed organ (ileum). All patients who experienced cuff separation after hysterectomy underwent surgical repair few hours after the event. All women who needed vaginal resuture after abdominal hysterectomy and vaginal hysterectomy underwent an open abdominal re-intervention, except for one patient who had transvaginal resuture. Among women in the total laparoscopic hysterectomy group, the vault repair was performed laparoscopically in 22 (95.6%) cases and vaginally in one (4.4%) case. Intravenous antibiotics therapy was administered in each case. No case of redehiscence after vault repair was observed. Figure 2 shows a case of vaginal evisceration after endoscopic hysterectomy and the postoperative result at the end of transvaginal repair.
The present study confirms that, although low, the risk of vaginal cuff dehiscence is higher after total laparoscopic hysterectomy compared with abdominal and vaginal hysterectomy. Interestingly, when the vaginal vault is sutured transvaginally at the end of a total laparoscopic hysterectomy, the risk of dehiscence appears significantly lower compared with laparoscopic suture and similar to the rate of separations observed after open and vaginal hysterectomies. Regarding the type of colpotomy, our data suggest that the use of monopolar energy as well as the amount of power used are not clearly associated with an increased risk of vaginal cuff dehiscence.
During the past decade a concerning increase in the incidence of vaginal separations and eviscerations after hysterectomy has been observed.1,3,6–8,13 Recent articles suggest that these complications are becoming more and more common because of the wide diffusion of endoscopic techniques: in fact, total laparoscopic hysterectomy has been associated with an approximately 3-fold to 17-fold increase in the risk of vaginal cuff dehiscence compared with the traditional abdominal or vaginal hysterectomies according to different series.1,3,6,7
A number of different possible theories have been proposed to explain the relationship between total endoscopic hysterectomy and cuff separations. Several authors have speculated that the cauterization with consequent cell necrosis and tissue damage associated with the use of monopolar knife could have a negative effect on the healing of the vaginal cuff and should be regarded as the main factor responsible for the worrisome link between endoscopic hysterectomy and risk of cuff separation.3,7 Unfortunately, the literature is devoid of direct comparisons between colpotomy with cold knife compared with monopolar energy in terms of risk of cuff dehiscence. Similarly, little attention has been dedicated to the power at which monopolar spatula or hook are set at the time of colpotomy. One would expect that decreasing the power of monopolar knife should reduce cauterization and, consequently, the likelihood of subsequent vaginal dehiscence. However, the findings of the present study appear to suggest that lowering monopolar energy from 60 watts to 50 watts when the vaginal cuff is incised does not reduce the risk of vaginal separations in the postoperative period. Moreover, the rate of vaginal dehiscences in the abdominal hysterectomy group was comparable when colpotomy was performed with monopolar energy rather than cold knife. Finally, no significant difference was observed in terms of cuff separations when comparing total laparoscopic hysterectomy with transvaginal suture (when colpotomy was always performed with monopolar energy) compared with vaginal hysterectomy (when colpotomy was always performed with cold knife) or compared with abdominal hysterectomy (even after stratification by modality of colpotomy). Given all these considerations, the present study seems to substantially reduce the possible role of the cauterization of vaginal tissue induced by monopolar energy in the pathogenesis of cuff dehiscences.
A large systematic review published in 2011 and including more than 13,000 minimally invasive (laparoscopic and robotic) hysterectomies from 57 series shows that transvaginal closure after total laparoscopic hysterectomy is associated with threefold and ninefold reductions in the risk of vaginal cuff dehiscence compared with laparoscopic and robotic suture, respectively.8 The findings of the systematic review of the literature corroborate the results of the present observational series: despite the different study designs, the route to perform vaginal closure appears to heavily influence the likelihood of vaginal dehiscence, with similar figures between the two reports (0.86% and 0.64% separations for laparoscopic closure compared with 0.24% and 0.18% separations for transvaginal closure in the present series and in the review, respectively). These results apparently contradict a previous report by Hwang et al,14 who did not find any difference in terms of risk of dehiscence between the vaginal route and laparoscopic suture for vaginal cuff closure in patients undergoing total laparoscopic hysterectomy. However, only 471 patients were included in the series by Hwang et al, thus making the study underpowered to detect possible differences in such a rare type of complication.
In their insightful study published in 2011, Hur et al highlighted that there was an important difference in terms of cuff separation rate between the first and the last laparoscopic procedures performed at their institution; in fact, in the period between 2001 and 2005, they observed eight dehiscence occurrences out of 290 laparoscopic hysterectomies (2.76%) compared with five dehiscence occurrences out of 668 procedures between 2006 and 2009 (0.75%).6,15 These data suggest that an improvement in the experience of surgeons can help in preventing the threatening occurrence of vaginal cuff separation. Unfortunately, the number of centers included in the present study as well as the different surgeons involved in the operations made it impossible for us to perform a meaningful analysis regarding the effect of increasing surgical volume on the risk of vaginal dehiscence.
Cronin et al7 recently suggested some possible modalities to try to reduce the incidence of vaginal cuff dehiscence after endoscopic interventions, such as the use of bidirectional barbed sutures, two-layer closures, and monopolar rather than bipolar cautery. Siedhoof et al16 in a series of 387 patients recently found that the use of barbed suture drastically decreased the risk of posthysterectomy cuff separations. However, because of the small number of patients included, we believe that this as well as other proposed preventive strategies still deserve further investigation.
It is important to notice that in the present study, dehiscences after laparoscopic hysterectomies were mainly spontaneous and occurred earlier than in cases of abdominal hysterectomy and vaginal hysterectomy. A possible hypothesis to (at least partially) explain these results is that when cuff closure is performed endoscopically, the magnified view provided by the laparoscope can induce the surgeon to include an insufficient amount of tissue in the suture, thus resulting in a higher rate of spontaneous and precocious separations. Unfortunately, we were not able to perform any useful analysis of the time to onset of dehiscence in the group with total laparoscopic hysterectomy with transvaginal cuff closure because of the low incidence of events in this group.
Another interesting finding of the present study is that women who underwent total laparoscopic hysterectomy for malignancies had a tendency toward a higher evisceration rate than women who had hysterectomy for benign disease. This difference could be attributable to the need of adjuvant treatment (chemotherapy and radiation therapy), which may impair tissue healing. Moreover, lymphorrhoea related to lymph node dissection could be responsible for a worse healing of the vaginal vault.17
A possible limitation of the present analysis is represented by its retrospective nature, which made it impossible to avoid possible reporting biases. Moreover, we were not able to correct for all possible confounders, including the experience of the operators and the different settings involved. Regarding surgical expertise, it is a common feeling that younger surgeons tend to prefer laparoscopy over the traditional vaginal or abdominal approach. Our study was not designed to explore this issue and does not have the ability to identify the role of surgical experience in the prevention of vaginal dehiscence. Considering other possible confounders, it should be acknowledged that data regarding medical comorbidities such as diabetes or chronic bronchopneumopathy were not available for several of the patients included. Moreover, we cannot categorically exclude that in unusual circumstances, late postoperative complications (ie, occurring after the last follow-up) were managed in other hospitals and this information was missed. However, the study results are highly consistent with the existing literature, thus strengthening our findings. Unfortunately, no comparison with robotic surgery and robotic cuff suture was possible in the present study. One of the most troublesome emerging aspects of robotic hysterectomy is represented by the extremely high likelihood of vaginal dehiscence,18,19 with published series reporting an incidence as high as 7.5%.19 Although it seems to be not easily realized, it would be extremely interesting to compare transvaginal compared with robotic suture at the end of robotic hysterectomy, with the aim of understanding whether the route of vaginal closure has an effect on decreasing cuff separations after robotic surgery, also.
We believe that the main merits of the present study are represented by the considerable number of hysterectomies included and by the deep analysis of both the modality of vaginal closure and the possible effect of electric energy on the risk of vaginal dehiscence. It has been strongly auspicated that researchers dedicate their attention to possible strategies for preventing vaginal separations, including different modalities of vaginal closure techniques.13 We believe that the present study pursues this intent.
In conclusion, the route to perform vaginal suture seems to play an important role in the prevention of vaginal dehiscence after total laparoscopic hysterectomy, and the adoption of a transvaginal approach could probably approximate the incidence of cuff separations to figures essentially comparable with those of abdominal hysterectomy or vaginal hysterectomy. The use of monopolar energy at the time of colpotomy appears to be secondary in the genesis of posthysterectomy vaginal dehiscences. We emphasize that endoscopic cuff suture is a highly technical and demanding procedure. Because transvaginal suture appears as a quick and reliable modality to accomplish vaginal closure, it should be taken into consideration when trying to optimize the technique of endoscopic hysterectomy and to reduce the incidence of vaginal cuff dehiscence. The adoption of a vaginal approach to vaginal closure could decrease the complexity of the entire laparoscopic hysterectomy, incrementing its adoption in nonreferral centers.20
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