Comparison of functional outcomes with purely laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy in obese women

25 décembre 2014

Auteurs : M. Joubert, T. Thubert, J.-P. Lefranc, C. Vaessen, É. Chartier-Kastler, X. Deffieux, M. Rouprêt
Référence : Prog Urol, 2014, 17, 24, 1106-1113




 




Introduction


Pelvic organ prolapse (POP) is a common condition. By the age of 80, a woman's lifetime risk of undergoing a surgical procedure for stress urinary incontinence (SUI) or POP is estimated to be 11% [1]. A minimally invasive laparoscopic approach for the treatment of POP (sacrocolpopexy) has been developed in recent years, and has been shown to be comparable to conventional surgery in terms of functional outcome, whilst demonstrating all of the advantages of laparoscopy [2]. Obesity, which is defined by a body mass index (BMI)≥30kg/m2, is endemic in industrialized countries. In 2008, the prevalence of obesity in the United States was estimated to exceed 30% in the adult population, and the combined age-adjusted prevalence of overweight and obesity among women was 64.1% (95% CI, 61.3%-66.9%) [3]. In 2010, an estimated 17% of adults were obese in the European Union [4].


POP surgery is required for some obese women, and sacrocolpopexy is considered to be one of the gold standards for the surgical treatment of POP. Since 2004, a robot-assisted laparoscopic approach to sacrocolpopexy (RALSCP) has been proposed as a viable alternative to the purely laparoscopic technique [5, 6, 7]. RALSCP appears to be a practical option for obese women, having similar rates of complication and equivalent outcomes to those reported for non-obese women [8]. One recent study compared the LS and RALSCP approaches in a normal-weight population [9]. However, there is currently no specific data comparing LS and RALSCP in obese women. The aim of our study was thus to compare the operative and functional outcomes of LS and RALSCP in women with a BMI greater than 30 kg/m2.


Methods


Population


In this study, we retrospectively reviewed all of the prospective data collected from obese female patients who had undergone RALSCP or LS between January 2008 and January 2013, and who had attended any one of five tertiary care centres in France. The following parameters were extracted from their charts: age at the time of surgery, BMI, menopause status, initial stage of genital prolapse (according to the Baden and Walker classification) [10], past medical history, obstetric and surgical histories, past prolapse treatment(s), date of the sacrocolpopexy procedure, operative and perioperative data, complications, anatomical results, and functional results.


Each patient underwent a pre-operative work-up, including urine analysis, a Pap smear, pelvic ultrasonography, and urodynamic exploration. Objective assessment of POP was carried out using a split speculum during a Valsalva manoeuver in the gynaecological position, following the POP ICS stage of POP [10]. Each surgeon performed a prolapse-reduction manoeuver using sponge-holding forceps in order to reveal the possible presence of masked urinary-stress incontinence.


Operative and perioperative data included: concomitant surgical procedure (subtotal hysterectomy or mid-urethral sling); conversion to a laparotomy or a vaginal procedure; length of the operation; blood loss; type of anaesthesia (according to the WHO classification); occurrence of complications; analgesic requirements; and length of hospital stay. The Ethical Review Committee (CEROG) examined the present study and found that it complied with the generally accepted scientific principles and ethical standards of medical research, and was in agreement with the laws and regulations of the country in which the research experiment was carried out (submission number CEROG-GYN-2011-08-01; CNGOF, Paris).


Surgical procedure


A laparoscopic sacrocolpopexy was performed by a senior surgeon on all patients, in accordance with the method statement provided hereafter. A pneumoperitoneum was created and four laparoscopic ports were placed: one 10 mm umbilical port, one 10 mm midline suprapubic port, and two 5 mm lateral ports. Following identification of the right ureter, the left iliac vein and the iliac-vessel junction, the peritoneum above the sacral promontory was incised medially to the right ureter and laterally to the sigmoid colon. Either a prosthetic macroporous monofilament polypropylene mesh, or a polyester mesh, were used in 2/39 (5.2%) and 37/39 (94.8%) patients, respectively. The bladder was dissected from the upper half of the anterior vaginal wall. A mesh was sutured to the anterior wall of the vagina using a non-absorbable suture. A posterior mesh was placed in 3/39 (7.6%) of patients, as a consequence of the presence of a posterior compartment vault (elythrocele, rectocele or enterocele). For the posterior mesh placement, a rectovaginal dissection was performed down to the level of the levator ani muscles, and a mesh was placed and sutured to the levator ani muscles using a non-absorbable suture, along the full length of the posterior vaginal wall. The upper extremity of the anterior mesh was sutured to the anterior vertebral ligament in front of the sacral promontory, using a non-absorbable suture. Complete peritonisation of the meshes was achieved by joining the edges of the peritoneum with an absorbable suture.


Concerning the RALSCP, all procedures were carried out with a three-arm da Vinci® surgical system, using the trans-peritoneal four-port technique, as described previously [9]. Two surgeons performed RALSCP on all of the women. These surgeons had already completed their training and carried out sacrocolpopexy by LS or RALSCP with the same operative skill. Following identification of the right ureter, the left iliac vein, and the iliac-vessel junction, the peritoneum over the sacral promontory was incised medially to the right ureter and laterally to the sigmoid colon. For the placement of the posterior mesh, the rectovagina was dissected down to the level of the levator ani muscles, and a mesh was placed and sutured with non-absorbable sutures along the full length of the posterior vaginal wall and into the levator ani muscles. The upper extremity of the anterior mesh was sutured with a non-absorbable suture to the anterior vertebral ligament at the level of the sacral promontory. Complete peritonization of the meshes was achieved by attaching the edges of the peritoneum using an absorbable suture. For both surgical procedures, the surgical time was defined as the duration of the procedure (excluding preparation and docking of the robot used for the RALSCP), plus the time required for insertion of the ports.


Complications


Concerning the reporting of morbidity and surgical complications, the authors followed the 10 criteria proposed by Martin et al. in 2002, as well as those established by the International Urogynecological Association/International continence society (IUGA/ICS), as stated in the European Guidelines [11, 12].


Follow-up


Post-operative follow-up visits were scheduled at 6 and 12 months, and then every year. During these visits, the POP was assessed using the POP ICS quantification. The surgery was considered to have been successful if the patient was symptomatically satisfied and the POP score was below stage 2 for all compartments.


Statistical analysis


The data was statistically analysed using the R statistical software (Bell Laboratories, Lucent Technologies, Paris, France). The descriptive statistics are given in the form of median values and IQRs (interquartile range). The Mann-Whitney U-test was used to compare continuous variables, and Fisher's exact test was used to compare categorical variables. A P -value of<0.05 was considered to be statistically significant.


Results


Population


Thirty-nine obese patients underwent a laparoscopic sacrocolpopexy (group 1), and 17 patients underwent a robot-assisted laparoscopic sacrocolpopexy (group 2). The median (IQR) BMI was 30.5kg/m2 (30-32) in group 1 vs 31.6kg/m2 (30-34) in group 2 (P =0.4). The median age was 54 years (48-58) in group 1 vs 63 (56-69) in group 2 (P =0.002). There was no statistical difference between the two groups for any of the other patient characteristics. These results are summarized in Table 1.


Surgery


The surgical data are shown in Table 2. No significant difference was observed between the groups, with respect to the need for a concomitant procedure, such as a subtotal hysterectomy or a mid-urethral sling. The perioperative complication rate was similar in both groups. In particular, for the LS group and RALSCP groups respectively: bladder injury 2.5% (1/39) vs 0% (0/17), P =0.6; and laparoconversion for perioperative complications 5.1% (2/39) vs 5.9% (1/17), P =0.6. Conversion to abdominal laparotomy was required for one patient (5.9%) in group 2, as a consequence of pneumoperitoneum intolerance. In the LS group, a conversion to abdominal laparotomy was required for 2 patients (5.1%), as a result of vessel injuries. Both of these cases resulted from difficult access to the promontory, due to the presence of excessive fat. In one case, a pre-sacral vessel injury occurred, and in the second case a left iliac vein injury occurred. As a consequence of difficulties experienced in achieving selective haemostasis of the vessel, the surgeon was forced to convert to laparotomy. The operative time was similar in both groups, with a mean value of 220minutes (170-320) vs 190minutes (160-237) for the RALSCP and LS groups, respectively (P =0.253) (Table 3).


Outcomes and complications


The median follow-up period was 14.9 months (IQR 8-25) in the LS group and 12 months (IQR: 7-15) in the RALSCP group (P =0.42). The overall anatomic repair rates were 98% and 94.1% for the LS and RALSCP groups, respectively (P =0.7). During the follow-up, a gynaecological examination revealed that prolapse of the posterior compartment had recurred in one patient in the RALSCP group after 12 months, and prolapse of the anterior compartment had recurred in one patient in the LS group. Both of these women underwent a subsequent procedure via the vaginal route. In the LS group, 3 (7.6%) post-operative complications occurred: an infected injury (n =1), a Douglas pouch haematoma (n =1) and a pelvic abscess (n =1). In the RALSCP group, there were no post-operative complications (P =0.6). The overall reoperation rate was similar in both groups: 18% (7/39) vs 5.9% (1/17), P =0.4. All of the post-operative complications are listed in Table 4, in accordance with the ICS/IUGA classification.


Discussion


The aim of this study was to establish a comparison between the LS and RALSCP procedures in obese women. It was observed that the overall anatomical success rate was 98% for the LS group, and 94.1% for the RALSCP group (P =0.7). Furthermore, no significant difference in complication rate was observed between the two groups, for which similar operative times were required.


In the past, abdominal sacrocolpopexy (ASC) was considered to be the gold standard treatment for genital prolapse [13]. The functional outcome, operative characteristics and complications associated with this surgical procedure have been evaluated for normal-weight and obese women. Bradley et al. [14] reported that perioperative and post-operative complications, as well as post-operative prolapse quantification were similar in obese and healthy-weight women. The differences between obese and non-obese women were related to the operative times only, these being significantly longer in the case of obese women (189min as opposed to 169min, P =0.02) [14]. The laparoscopic approach was developed over the past decade, in response to the ideal requirement for POP repair to be as little invasive as possible, with good anatomical and preserve functions. Only one previous study has evaluated the feasibility of this approach in obese women [15]. In the latter study, similarly to the results of Bradley [14], perioperative and post-operative complications, as well as post-operative prolapse quantifications, were similar in obese and healthy-weight women. Contrary to Bradley's findings [14], the operating times were similar in both populations, with 190min in obese women versus 180min in non-obese women, respectively (P =0.12). The inexperienced laparoscopic surgeon found that this procedure had some limitations, such as a reduced freedom of movement, two-dimensional vision, and a longer operative time as a consequence of the need for significant training. All of these drawbacks demotivated a large number of surgeons, who preferred to avoid the laparoscopic approach. Robotic-assisted surgery was thus developed to simplify this technique, through the addition of three-dimensional vision and 7 degrees of freedom. This simplified the complex laparoscopic tasks such as suturing and knot-tying, needed in the treatment of genital prolapse. One recent study evaluated the functional outcomes after robot-assisted laparoscopic sacrocolpopexy in women with a BMI above and below 30kg/m2 [8]. The overall anatomic repair rates were 94.1% and 97.4% for the obese and non-obese groups, respectively (P =0.95). No significant difference was observed between the two groups in terms of complication rates, with an overall reoperation rate (including surgery for de novo urinary-stress incontinence) of 5.9% in the obese group, versus 11.5% in the non-obese group (P =0.8). The operating time was the same in both groups: 220 vs 200min in the obese and non-obese groups, respectively (P =0.232).


One recent randomized trial comparing LS and RALSCP in 78 normal-weight women found that the costs of robotic sacrocolpopexy were higher than those of the conventional laparoscopic procedure, whereas the short-term outcomes (except for pain at 1 week, which was higher in RALSCP than in LS) and complications were similar [16]. One previous randomized trial found that patients who underwent RALSCP had significantly greater pain during rest and activity, from the 3rd to the 5th week following surgery, and required a more prolonged use of non-steroidal anti-inflammatory drugs [17]. Concerning the operating time (from incision to closure), both trials found that the total operative time was significantly longer in the robotic group than in the laparoscopic group. In addition, Anger et al. confirmed that the time spent in the operating room was greater in the case of robot-assisted surgery (202.8minutes vs 178.4minutes, P =.030) [16]. In a recent review of the literature made by Lee et al. [18], the overall mean operating time was 124 min (range: 55-185) for LS, and 202 min (range: 161-288) for RALSCP. Our study focused on obese people. Contrary to the case of normal-weight populations, we did not observe any significant differences in terms of operating time, even though the RALSCP does appear to be slightly longer, i.e. 220minutes vs 190minutes (P =0.25). In addition, the rate of concomitant procedures was similar in both groups 26/39 vs 13/17 (P =0.68).


In the current study, independently of the surgical approach, we did not encounter a high rate of (peri- or post-operative) complications. The overall reintervention rate (including de novo SUI surgery) was similar in both groups: 18% (7/39) vs 5.9% (1/17), P =0.4. The current opinion is that obese patients are at a higher risk of morbidity. A small number of previous studies have shown that abdominal surgery for a gynaecologically benign condition (other than POP) is associated with a greater incidence of wound infection in obese women, than in non-obese women [19, 20]. Only three previous retrospective studies have focused on the impact of BMI on the surgical outcomes of prolapse surgery. Chen et al. [21], who focused on vaginal surgery for prolapse or urinary incontinence, did not find any statistical difference in the proportion of subjects having at least 1 perioperative complication (20% in the obese group vs 15% in the non-obese group, P =NS). However, obese women were more likely to have an operative site infection (AOR=5.5 [95% CI, 1.7-24.7; P =0.01]) and morbidly obese patients (BMI≥35 kg/m2) were more likely to have a bladder injury (AOR=6.9 [95% CI, 1.7-24.0; P =0.003]). Nam et al. [22] found that vaginal surgery for POP in obese women is associated with a lower morbidity rate than abdominal surgery, in terms of blood transfusions or urinary retention. Araco et al. [23], who studied the influence of body mass index on the risk of vaginal mesh exposure following mesh repair of pelvic prolapses, found that a BMI≥30 kg/m2 conferred a 10.1 fold increase in the risk of developing erosion (22 months follow-up (range 12-48 months)). Clark et al. [24] found no correlation between BMI and POP recurrence rates following surgery for POP and/or urinary incontinence. These investigators followed 376 patients for a period of 5 years, during which only 36 patients (9.5%) underwent a total of 40 reoperations for surgical failure. Lo et al. [25] compared the surgical outcomes of anterior trans-obturator mesh and vaginal sacrospinous ligament fixation for severe pelvic organ prolapse, as a function of the patient's BMI, with a mean follow-up of 35±18.9 months. There were no differences between normal-weight and obese women, with respect to perioperative complications and vaginal mesh exposure rate (4.1%). In the present study, the overall reoperation and vaginal erosion rates were similar in the normal-weight population.


There is only one study (with a small sample size) that has focused on the impact of BMI on the functional outcome of genital prolapse surgery. The major limitation of all of these studies is their short follow-up period, ranging from 6 months to 2 years. Two years after abdominal sacrocolpopexy, Bradley et al. [14] found similar outcomes in obese and healthy-weight groups. Symptom resolution, measured according to the UDI, POPDI, and CRADI score changes, as well as satisfaction with surgery, did not differ between the groups. The POP-Q examination was the same in both groups, apart from the fact that a smaller maximum posterior vaginal descent (point Bp, cm) (-3.0 (-3.0 to -2.0)) was observed in the obese group than in the normal-weight groups (-2.0 (-3.0 to -1.0)) (P =0.003). Mcdermott et al. [26] compared abdominal sacrocolpopexy and LS in obese women with a follow-up of 6 to 12 months. They found a similar overall satisfaction rate (86/100 in the ASC vs 81/100 in the LS, P =0.8) and similar successful anatomical results (88/100 in the ASC vs 88/100 in the LS, P =1). Following a laparoscopic sacrocolpopexy, Thubert et al. [15] found a similar rate of short-term satisfaction (6 months) in the obese and non-obese populations. The patients' global rate of satisfaction with LS was 74.5% in the obese group and 67.9% in the non-obese group (P =0.09). The short-term anatomical results assessed by POP-Q-ICS for post-operative functional disorders described by the obese and non-obese groups (de novo constipation, de novo anorectal dysfunction, voiding dysfunction, and de novo dyspareunia) were similar. Lo et al. [25] compared the outcomes of vaginal prolapse surgery as a function of BMI, revealing an objective cure rate of 90.6% in obese patients, with a 35±18.9 month follow-up. The only difference with respect to the normal-weight population was related to the POPDI-6 (P <0.037) and the PISQ-12 (P <0.005), with less improvement in the obese than in the non-obese group.


One of the limitations of the current series is its retrospective design and the small size of the population. Nevertheless, this is the first study to have compared the laparoscopic and robot-assisted approaches for the treatment of genital prolapse in obese women. Another limitation of our study is the short-term follow-up of these patients. An extended follow-up period would be needed to confirm these findings over the longer term, even though obesity is not considered to be a factor affecting recurrence in genital prolapse. A randomized prospective study, made with a larger population, would be of considerable interest in comparing the performance achieved using the vaginal route with that of the robot-assisted and laparoscopic approaches, for the treatment of prolapse in obese women.


Conclusion


RALSCP can be a viable alternative to laparoscopy for the treatment of prolapse in obese women. It is shown that an inexperienced laparoscopic surgeon can achieve the same anatomical results and the same rate of perioperative complications as an experienced RALSCP surgeon. Nevertheless, when performed by a trained urogynecological staff surgeon, experienced in the use of both RALSCP and LS, LS should be preferred for reasons of cost.


Disclosure of interest


The authors declare that they have no conflicts of interest concerning this article.




Table 1 - Patient's characteristics.
  Laparoscopy  RASCLP  P  
n   39  17   
BMI (kg/m2) median (IQR)
[Extrem] 
30.48 (30-32)
[30-42] 
31.6 (30-34)
[30-36] 
0.402a 
Age (years) median (IQR)  54 (48-58)  63 (56-69)  0.002a 
Parity (n ) median (IQR)  2 (2.0-3.5)  3 (1-3)  0.220a 
Post-menopausal status n (%)  21/39 (54%)  15/17 (83.3%)  0.030b 
Pessary use n (%)  1/37 (2.7%)  1/17 (5.6%)  0.804b 
Pelvic floor rehabilitation n (%)  5/37 (13.5%)  1/17 (5.6%)  0.716b 
Tobacco use n (%)  6/39 (15%)  1/17 (5.6%)  0.582b 
Previous C-section n (%)  4/39 (10%)  3/17 (16.7%)  0.741b 
Previous hysterectomy n (%)  2/39 (5%)  4/17 (22.2%)  0.114b 
Previous POP surgery n (%)  9/39 (23%)  2/17 (11.2%)  0.539b 
POP stage (ICS POP-Q)
Stage 0-1
Stage 2
Stage 3-4 

0/39 (0%)
3/39 (8%)
36/39 (92%) 

0/17 (0%)
2/17 (11.2%)
15/17 (88.8%) 

0.985b 
Bp (ICS POP-Q)
Stage 0-1
Stage 2
Stage 3-4 

14/39 (36%)
15/39 (38%)
10/39 (26%) 

5/17 (29.4%)
6/17 (35.3%)
6/17 (29.4%) 

0.870b
0.940b
0.679b 
SUI patent n (%)  5/39 (13%)  2/17 (11.2%)  0.741b 
SUI masked n (%)  13/34c (38%)  10/15c (66.7%)  0.894b 



Légende :
BMI: body mass index; ICS: international continence society; IQR: interquartile range; POP: pelvic organ prolapse; POP-Q: pelvic organ prolapse quantification grading system; SUI: stress urinary incontinence.

[a] 
Welch two sample t -test (Student t -test).
[b] 
Pearson's Chi2 test with Yates' continuity correction (Chi2 test).
[c] 
Patients without patent stress incontinence.


Table 2 - Operative data.
  Laparoscopy  RASCLP  P  
n   39  17   
Concomitant subtotal hysterectomy n (%)  13/37a (35%)  2/13a (15.4%)  0.324b 
Concomitant mid-urethral sling n (%)  13/39 (33%)  11/17 (64.7%)  0.059b 
Mesh location n (%)
Anterior mesh only
Posterior mesh only
Both anterior and posterior meshes 

3/39 (8%)
2/39 (5%)
34/39 (87%) 

0/17 (0%)
0/17 (0%)
17/17 (0%) 

<0.005b 
Operative duration (min)
Median (IQR) 
190 (160-237)  220 (170-320)  0.253c 
Hospital length of stay (days) median (IQR)  4 (3.0-4.0)  4 (4-5)  0.989c 



Légende :
n : number; IQR: interquartile range.

[a] 
Patients without previous hysterectomy.
[b] 
Pearson's Chi2 test with Yates' continuity correction (Chi2 test).
[c] 
Welch two Sample t -test (Student t -test)


Table 3 - Complications and outcomes.
  Laparoscopy  RASCLP  P  
n   39  17   
Bladder injury n (%)  1/39 (2.5%)  1 (5.9%)  0.866a 
Rectal injury n (%)  NS 
Laparoconversion n (%)  2/39 (5.1%)  1 (5.9%)  0.596a 
Wound infection n (%)  NS 
Douglas pouch haematoma  NS 
Bowel occlusion  NS 
Pelvic abscess  NS 
Reoperation for immediate complications (C1)  2/39 (5.1%)  0 (0%)  0.879a 
Reoperation for urinary incontinence (C2) n (%)  2/39 (5.1%)  0 (0%)  0.879a 
Reoperation for mesh exposure (C3) n (%)  2/39 (5%)b  0 (0%)  0.879a 
Reoperation for recurrent prolapse (C4) n (%)  1/39 (2.5%)  1 (5.9%)  0.866a 
Global reoperation rate (C1+C2+C3+C4) n (%)  7/39 (18%)  1 (5.9%)  0.44a 
Post-operative POP stage (ICS POP-Q) n (%)
Stage 0-1
Stage 2
Stage 3-4 

34/39 (88%)
4/39 (10%)
1/39 (2%) 

16 (94.1%)
0 (0%)
1 (5.9%) 

0.762a 
Post-operative de novo functional disorders
Constipation
Straining to defecate
Straining to void
Dyspareunia 

3/39 (7.6%)
1/39 (2.5%)
2/39 (5%)
0/39 (0%) 

0 (0%)
0 (0%)
1 (5.9%)
0 (0%) 

0.596a
0.666a
0.596a
NS 



Légende :
ICS: international continence society; n : number; POP-Q: pelvic organ prolapse quantification grading system.

[a] 
Pearson's Chi-squared test with Yates' continuity correction (Chi2 test).
[b] 
All the patient have been reoperated by vaginal approach with partial resection of the mesh and vaginal suture. Patients followed with a POP-Q exam (3 loss of sight).


Table 4 - Operative complications using IUGA/ICS classification.
  Laparoscopy  RASCLP  P  
T1 complications  1 (4A/T1/S5)
2 (7A/T1/S5) 
1 (7B/T1/S5)
 
0.747a 
T2 complications  1 (7A/T2/S2)
1 (1D/T2/S2)
1 (6D/T2/S3) 
0.596a 
T3 complications  1 (2B/T3/S1)  0.664a 
T4 complications  1 (2B/T4/S1)  1 (1B/T4/S2)  0.866a 



[a] 
Pearson's Chi2 test with Yates' continuity correction (Chi2 test).


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