50 patients (45 women) median age 54 (range 24-71 years were referred with early symptomatic failure (n=27) or major complications arising post LVMR (n=23). Their median length of stay was 1 day (range 1-4). There were no conversions or postoperative complications.
Early symptomatic failure following a deficient LVMR [Table 1]
Three men, (median BMI 33Kg/m2) were referred following an inability of the referring surgeon to perform the LVMR. Three women had undergone two attempted LVMRs; in each case there was no evidence of a ventral dissection, the mesh “lying free” on the pelvic brim. 11 women had undergone LVMR using PermacolTM(Covidien, Gosport, UK) within 4-26 months (median 11). Apart from staples and a flimsy fibrous band at the sacral promontory there was no structural support or sutures within a fat laden rectovaginal septum.
Eight developed full thickness prolapse within one year; in seven (two PermacolTMmeshes) this followed de-attachment from the promonontory (n=5) and wrongly positioned staples to the upper sacrum (n=2). In each case only two staples had been used. The remaining mesh had been sutured to the right lateral rectal wall allowing the formation of a large left sided peritonealocele with enterocele. Two men with continuing ODS had an inadequate strip of mesh sutured to the right side of the upper rectum with no recto-vesicle dissection.
Management of major mesh complications [Table 2]
Four patients were referred with recurrent ODS and new onset pelvic pain secondary to a stricture in the mid rectum (n=3) and recto-sigmoid; all strictures were associated with the tail of the mesh which had been stapled to the mid sacrum rather than the promontory. There were two erosions into the rectum. Each revision was effective in relieving the pelvic pain. Nine women were referred with mesh erosion into the vault (n=7), mid vagina (1) and bladder (n=1); all had undergone a previous hysterectomy and were postmenopausal.
Three patients were referred with chronic pelvic pain and localised vaginal tenderness unresponsive to epidurals and poly-pharmacy. One was associated with pudendal nerve irritation, which had started in the recovery room following the original surgery. Each mesh was associated with excessive chronic inflammation; replacement with Teflon coated polypropylene lead to symptom improvement sufficient for two to withdraw their oral medications. One developed recurrent ODS requiring the addition of a symptom relieving posterior STARR. The same patient has since had a transgluteal pudendal nerve release with a 50% reduction in patient reported symptom severity and an ability to sit for longer periods of time. In the remaining patient we used a lightweight multifilament VyproTM mesh (Ethicon, Edinburgh, UK). Although this improved the dyspareunia, recurrent ODS developed over a two-year period as the mesh “stretched”. The patient is now requesting a further revision.
Revisional surgery was associated with significant improvements in median postoperative OD and Wexner FI scores at one year (two tailed t test; p < 0.0001) (Figures 1 & 2). Significant improvements in QoL scores and linear VAS for bowel symptom severity were seen at 3 and 12 months, improvements that were then maintained over the following year (Figure 3 & 4).
Table 1. Causes of early failure post LVMR (n=26)
Unable to perform LVMR 3
Recurrent external prolapse within 6/12 8
LVMR x 2 3
Recurrent ODS/RI 13
Table 2. Referrals with major complications post LVMR (n=23)
Rectal strictures 4
Rectovaginal fistula 3
Surgery for rectal prolapse and ODS should be safe, effective, long lasting, and free of morbidity with patient satisfaction. LVMR has a relatively low risk of laparoscopy-related complications such as port site hernias, port site haematoma and inadvertent enterotomy and procedure specific mesh related complications, which have been reported in around 2% and have serious consequences1, 2, 13 The technique requires that the surgeon must have substantial experience in laparoscopic colorectal surgery and be able to carry out the ventral rectal dissection down to the pelvic floor but even then there is a continuing learning curve1,2,13. Although it has not been reported we would suggest the learning curve might influence the functional outcome and as this paper demonstrates the complication rate.
The most serious complications inherent to the LVMR are mesh related (infection, erosion and extrusion) and failure. The 2008 NICE review14 of surgery for pelvic organ prolapse (POP) demonstrates that these two complications relate to the type of mesh used and are a function of time/follow-up. Although erosion rates were 0% for biologic (Xenografts), 14% for combined synthetic and 7% for synthetic meshes, the overall failure rate for biologic’s was substantially higher at 23% vs. 9% for synthetic mesh.
Mesh complications as this paper shows are amenable to corrective surgery, which at times can be complex and that this invariable leads to an improvement in overall function (OD and FI scores) and quality of life which seems to be maintained over a two year follow-up. Unless the sepsis has made the mesh freely mobile within the rectovaginal septum, it is our experience that it is impossible to remove and correct from below without serious risk to potentially causing a rectovaginal fistula, particularly if the erosion is at the vault or posterior fornix. Laparoscopic removal whilst being a technical challenge is feasible and usually without complication.
Failure after PermacolTM LVMR defined as recurrence of symptoms and or of prolapse has been reported in 12% and 21% of patients at a median follow-up of 1 and 2 years15, 16. Two studies 17,18 of rectocele repair using the same Xenograft report a 41% anatomical recurrence at 3 years, the majority of these patients reporting persisting ODS. These failures may however simply reflect the underlying collagen disorder that predisposed the patients to getting POP/ODS in the first instance.
Synthetic mesh has the advantage of high tensile strength, immediate availability, and cost-effectiveness19and tissue integration20. A study of 446 patients21 undergoing laparoscopic sacral colpopexy with polypropylene reported a 1% risk of mesh extrusion.
Learning LVMR presents two types of challenges: anatomical and technical. For trainee surgeons the anatomy and dissection planes must be learned. For experienced surgeons, transitioning to laparoscopy requires adjusting to a new perspective on pelvic and abdominal anatomy. Cognitive and technical skills modulated by judgment are the components of competency, particularly “difficult” operations like LVMR. However, it is these innate technical abilities (visual hand response, visual information processing, visual spatial memory etc.,) that represent the limiting factor in determining the ultimate level of operator skill and are aspects of performance that do not always improve with practice22. Trainees need to develop their skills through23 mentorship and practice outside the operating theatre. Human cadavers offer realistic anatomy and tissue haptics. However, they are expensive, restricted and lack objective assessment. Performance feedback helps improvement and performance improvement reinforces trainees24. Objective assessment of surgical performance (including judgment) can only be obtained by reviewing unedited videotapes of surgical procedures for errors and quality of performance by at least two unbiased experts. Within the current Lapco programme, 30% of “trained” consultants fail this type of “sign-off” assessment.
This study highlights the importance of achieving the required competencies and specialist experience in LVMR and implies the need for interested surgeons to have undertaken a relevant supervised training programme and be willing to submit data to a national prospective clinical audit scheme so that the outcomes and complications can be established. However, the reality is that the adoption of new procedures like LVMR tends to occur without thought to a careful assessment and credentialing of the surgeon’s technical proficiency. Given the complexity of benign pelvic floor disease, the latter needs more robust examination. Revisional surgery as this report demonstrates is appropriate and can improve both functional outcomes and QoL but should, because of the potential high rate of complications, only be undertaken in specialist centers by surgeons with extensive experience.
In conclusion, revisional surgery by specialist units post LVMR failure or for the development of complications is appropriate and can improve function and QoL. Choice of mesh used is a balance between recurrence with xenografts and mesh infection and extrusion with synthetics. We advise caution on the widespread uptake of expensive xenografts in what is probably a cohort of patients with an underlying collagen disorder. RCTs with long-term follow-up would offer great insights into the ideal mesh for LVMR and method of attachment. This sub-set of patients highlights the potential problems of uncontrolled-uptake of new interventional procedures and the need for guidelines on training, service provision and service commissioning in support of this fledgling discipline as well as the need for a network of tertiary centers to provide help with difficult cases, especially revisional surgery.
Figure 1. Pre vs. Postoperative ODS scores (n=50) at 1 year (two tailed t test; p< 0.0001). The horizontal bars indicate the median values.
Figure 2. Pre & post-operative Wexner Faecal Incontinence (FI) scores at 1 year (n=50) (two tailed t test; p < 0.0001). The horizontal bars indicate the median values (if not visible this indicates that the median is 0).
Number pairs 50 50 33 17 5
Figure 3. QOL (BBUSQ-22) scores. The horizontal bars indicate the median values: pre-operatively v 3/12 (two tailed t test; p<0.0001); 3/12 v 1 year (p=0.015); 1 and 2 years – NS.
Number pairs 50 50 33 17 5
Figure 4. Linear Analogue Score for severity of bowel symptoms. Pre-operative v 3/12 (Two tailed t test; p < 0.0001), 3/12 v 1 year (p = 0.0151); 1 vs. 2 years NS. The horizontal bars indicate the median values (if not visible this indicates that the median is 0).
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