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How to deal with complications post Lap ventral Mesh rectopexy

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25/08/2012

How to deal with complications after laparoscopic ventral mesh rectopexy (LVMR): lessons learnt from a tertiary referral centre.

 

 

 

A Hamoudi-Badrek, GL Greenslade*, AR Dixon

Depts. Colorectal & Pelvic Floor Surgery, Anaesthesia and Chronic Pain* Frenchay & SPIRE Hospitals Bristol

 

 

 

Correspondence to Mr Tony Dixon,

Anthony.Dixon@nbt.nhs.uk

 

Key words: complications, morbidity, laparoscopic ventral mesh rectopexy, complications, remedial surgery, consultant training

 

Abstract

Aims. Laparoscopic Ventral mesh rectopexy (LVMR) is increasingly recognised as having utility in rectal prolapse, obstructed defaecation (ODS), faecal incontinence (FI) and multi-compartment pelvic floor dysfunction (PFD). This study aimed to highlight gaps in service provision and areas for improvement by examining a cohort of patients with complications referred to a tertiary center.

Methods. Examination of a password protected electronic database of all LVMRs operated on in one institution.

Results.  50 patients (45 women) aged 24-71 (median 54 yrs) were referred with early symptomatic failure (n=27) following a poorly executed LVMR or major mesh complications (erosion into other organ, fistulation, stricturing) (n=23).  All were amenable to remedial laparoscopic surgery. Functional improvements in pre and postoperative ODS, Wexner (FI) scores (two tailed t test; p<0.0001) were seen along with QoL (BBUSQ-22) scores at 3 months (two tailed t test; p<0.001) and normalization at one year (p<0.015).  This was mirrored by improved Linear Bowel Severity VAS scores (two tailed t test; p < 0.0001 [3/12] and p = 0.0151 [at 1 year].

Conclusions.  LVMR can be associated with complications arising from poor technique, or operation specific complications that are amenable to complex revisional laparoscopic surgery with significant improvement in quality of life and functional outcomes.

What is new in this paper

This is the first reported case series examining complications arising post LVMR, their surgical correction and potential avoidance.

 

 

 

 

 

 

 

 

 

 

 

Introduction

Since its origins in 1996 as a treatment of rectal prolapse1,2 nerve-sparing laparoscopic ventral mesh rectopexy (LVMR) has gained increasing worldwide acceptance.  Several reports have also confirmed its efficacy and reproducibility in correcting symptomatic intussusception, with significant improvements in obstructed defaecation (ODS) and faecal incontinence2-4. The technique is based on correcting the descent of the posterior and middle pelvic compartments combined with reinforcement of the vaginal septum and elevation of the pelvic floor.  LVMR also minimises the incontinence and dyspareunia that can follow the more traditional trans-anal and trans-vaginal approaches5-7. LVMR is particularly advantageous for the “super elderly”. It is however technically demanding and requires a complete ventral dissection of the rectovaginal septum (recto-vesical in males) down to the pelvic floor and suturing skills within a confined space using instruments that are at their limit.  Even in “expert” hands the technique is not without complications2.

The aim of this paper was to focus on the tertiary referral practice of a group of patients who have failed, or ran into trouble post LVMR.  To the best of our knowledge, this is the first such report in the literature.

 

Patients and methods

All patients referred between Jan 2006 and Jan 2012 post LVMR with recurrent external prolapse, ODS symptoms or complications arising out of the procedure were analysed.  Data collected included patient demographics, pre-operative details, ODS9 and Wexner faecal incontinence (FI)10 scores, operative information and clinical course to last follow-up.  A validated Quality of Life questionnaire (Birmingham Bowel and Urinary Symptoms Questionnaire-22, BBUSQ-22)12 was completed pre-operatively and at regular postoperative intervals (3, 12, 18, 24 months).  Primary outcomes were effect on function (ODS and FI and bowel disturbance VAS [Visual analogue scores]) and the impact upon QoL.

All underwent a thorough examination, dynamic defaecography, anorectal physiology (when appropriate) +/- EUA and laparoscopy.  Patients with pelvic pain were evaluated in conjunction with a chronic pain consultant; all received Gabapentin (600 or 900mg) pre-medication and a 24hr Ketamine infusion.

 

Statistical Analysis

Changes in pre and postoperative ODS, Wexner and QOL scores were analysed using the paired t-test (2 tailed), Prism 5 for Mac OS X software (version 5.0, © 1994- 2010 Graphpad Software, San Diego, California, USA).  A p value <0.05 was considered significant.

 

Surgical Technique

The surgical technique varied with the underlying indication but for each case there were several underlying principles. 

·       All dissection was conducted using hook diathermy down to the pelvic floor with removal of the original mesh and replacement by lightweight Teflon coated polypropylene (PFM Medical UK, Stockport) using PDS.

·        Mesh de-attachments were reattached using new mesh anchored to the promontory with ProtacksTM (Covidien, Gosport, UK) and sutured (1 Ethibond) to the original mesh.

·       Rectal injuries were managed by laparoscopic anterior resection and a limited LVMR using a biologic mesh above the anastomosis.

·        Defunctioning of rectovaginal fistulas with laparoscopic removal of mesh and repairing the rectum if high or transvaginally if low.

·        All other erosions were managed by laparoscopic mesh removal, repair of the defect and insertion of a biologic mesh.

 


Results

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

Pain/dyspareunia 5

Mesh erosion

Rectum 2

Vagina 8

Bladder 1 

 

 

 

 

 

 

 

 

 

 

Discussion

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.

 

 

 

 

 

ODS redx.tiff

 

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.

 

 

 

 

Wexner rex.tiff

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).

 

 

 

QOLrdx.tiff

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.

 

 

 

 

 

 

 

 

 

 

LBowS redx.tiff

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).

References

1. D’Hoore A, Cadoni R, Penninckx F. Laparoscopic ventral rectopexy for total rectal prolapse: long-term outcome. Br J Surg 2004; 91: 1500-5.

2. Slawik S, Soulsby R, Carter H, Payne H, Dixon AR. Laparoscopic ventral rectopexy, posterior colporrhaphy and vaginal sacrocolpopexy for the treatment of recto-genital prolapse and mechanical outlet obstruction. Colorectal Dis 2008; 10: 138-43.

3. Collinson R, Wijffels N, Cunningham C, Lindsey I. Laparoscopic ventral rectopexy for internal rectal prolapse: short-term functional results. Colorectal Dis 2010; 12: 97-104.

4. Wong M, Meurette G, Abet E, Podevin J, Lehur PA. Safety and efficacy of Laparoscopic ventral mesh rectopexy for complex rectocele. Colorectal Dis 2011; 13: 1019-23

5. Kahn MA, Stanton SI. Posterior colporraphy: its effects on bowel and sexual function. Br J Obstet Gynaecol 1997; 104: 882-6.

6. Farid M, Madbouly K, Hussein A, Mahdy T, Moneim HA, Omar W. Randomised controlled trial between perineal and anal repairs of rectocele in obstructed defaecation. World J Surg 2010; 34: 822-9. 

7. Ho YH, Ang M, Nyam D, Tan M, Seow-Choen F. Transanal approach to rectocele repair may compromise anal sphincter pressures. Dis Colon Rectum 1998; 41: 354-8.

8. Wijffels N, Cunningham C, Dixon A, Greenslade G, Lindsey I. Laparoscopic ventral rectopexy for external rectal prolapse is safe and effective in the elderly. Does this make perineal procedures obsolete? Colorectal Dis. 2011; 13: 561-6.

10. Renzi A, Izzo D, Di Sarno G, Izzo G, Di Martino N. Stapled transanal rectal resection to treat obstructed defecation caused by rectal intussusception and rectocele. Int.J Colorectal Dis. 2006; 21:661–7.

11. Agachan F, Chen T, Pfeifer J, Petachia R, Wexner S. A constipation scoring system to simplify evaluation and management of constipated patients. Dis.Colon Rectum 1996; 39:681–5.

12. Hiller L, Bradshaw HD, Radley SC, Radley S. Criterion validity of the BBUSQ-22: a questionnaire assessing bowel and urinary tract symptoms in women. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18:1133-7

13. Esschert JW, Geloven AA, Vermulst N, Groenedijk AG, Wit LT, Gerhards MF. Laparoscopic ventral rectopexy for obstructed defecation syndrome. Surg.Endosc 2008; 22: 2728-32.

14. Jia X, Glazener C, Mowatt G, Jenkinson D, Fraser C, Burr J.  Systematic review of the efficacy and safety of using mesh in surgery for uterine or vaginal vault prolapse.  NICE guidelines 2008.  IPG267.

15. Wahed S, Ahmad M, Mohiuddin K, Katory M, Mercer-Jones M. Short Term Results for Laparoscopic Ventral Rectopexy using Biologic Mesh for Pelvic Organ Prolapse. Colorectal Dis. 2011 Dec 18. doi: 10.1111/j.1463-1318.2011.02921.x. [Epub ahead of print].

16. Enríquez-Navascués JM, Elósegui JL, Apeztegui FJ, Placer C, Borda N, Irazusta M, Múgica JA, Murgoitio J.  Ventral rectal sacropexy (colpo-perineal) in the treatment of rectal and rectogenital prolapse.  Cirugía Española 2009; 86: 283 - 9.

17. Kovoor E, Hooper P. Assessment and management of pelvic organ prolapse.  Obstet Gynaecol Reprod Med 2008; 18: 241-6.

18. Altman D, Zetterström J, Mellgren A, Gustafsson C, Anzén B, López A.  A three-year prospective assessment of rectocele repair using porcine xenograft. Obstet Gynecol. 2006; 107:59-65.

19. Birch C. The use of prosthetics in pelvic reconstructive surgery. Best Pract Res Clin Obstet Gynaecol. 2005; 19:979-91.

20. Boulanger L, Boukerrou M, Lambaudie E, Defossez A, Cosson M.  Tissue integration and tolerence to meshes used in gynaecological surgery: an experimental study. Eur J Obstet Gynaecol reprod Biol 2006; 125: 103-8.

21. Stepanian AA, Miklos JR, Moore RD, Mattox TF. Risk of mesh extrusion and other mesh-related complications after laparoscopic sacral colpopexy with or without concurrent laparoscopic-assisted vaginal hysterectomy: experience of 402 patients. J Minim Invasive Gynecol. 2008; 15:188-96.

22. McMillan AM, Cuschieri A. Assessment of innate ability and skills for endoscopic manipulation by the Advanced Dundee Endoscopic Psychomotor Tester: predictive and concurrent validity. Am J Surg. 1999; 177: 274–277.

23. Miskovic D, Wyles SM, Ni M, Darzi AW, Hanna GB. Systematic review on mentoring and simulation in laparoscopic colorectal surgery. Ann Surg. 2010 Dec; 252:943-51.

24. Wyles SM, Miskovic D, Ni M, Kennedy RH, Hanna GB, Coleman MG. 'Trainee' evaluation of the English National Training Programme for laparoscopic colorectal surgery. Colorectal Dis. 2012 Jun;14: e 352-7.

 

 

 

 


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