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Monday, October 12, 2009

Structured Reconstructive Surgery and Pelvic Organ Prolapse

Declare the past, diagnose the present, foretell the future; practise these acts. As to diseases: make a habit of two things- to help, or at least do no harm. Hippocrates; Epidemics,Bk I, sect XI

Anyone who does surgery knows that he needs to be prepared to deal with successes and failures. A third dimension in modern pelvic floor surgery is the complications caused by the surgical onslaught. To deal with this can be the biggest challenge a surgeon can have.

Our ability to assess results of surgery -be it in defining successes or defining failures- leave a lot to be desired. In most reports the focus is on the “cure rates”, without a good definition on what exactly a cure rate is. Failures to cure the defect or damage repaired usually needs to be found by default. Mention of complications caused by the surgeon is mandatory in most assessments.
The yardstick of successes and failures of surgical results, though, is not only the claiming of successful correcting the damage or defect, but also the ability to deal with the complications.

With a focus on the suboptimal results, be it failing to correct what had been set out to be done, or causing damage -even if the defect had been corrected-, one come across what can be called the undo re-do factor of surgery. Before the surgical correction of the defect can be done with a secondary procedure (re-do) the after effects of the primary surgery must be undone (undo).This factor is what in the end will be the surgical legacy or footprint of the surgeon.

This undo re-do factor is usually dependant on the primary surgical procedure, more so when a complication arise due to the method used. To undo surgery after it failed to correct the defect is usually not much of a problem, to re-do it is the challenge. To undo a complication which is due to the method used -although the success to correct the defect is 100%- can be a challenge , as is the re-do process that needs to follow.

This philosophical point is nowhere more relevant than in prolapse surgery of especially the anterior compartment. The availability of different techniques to treat the same pathology tells us that there is no golden standard.
The different methods available can best be compared looking at their respective undo re-do factors.

Prolapse surgery of yesteryear is based on getting rid of the bulging vaginal wall- it is seen as a central bulge of the underlying organ into the non supportive vaginal wall. The bulge is directly folded back to take the underlying organ away from the vaginal cavity. In the resultant surgery, tissue –be it vaginal skin or even perfectly normal organs like the uterus- is being removed. The formation of scar tissue can be experienced as an advantage. The first attempt at surgery is usually the best chance of success. In this type of surgery no reference is made to seek out and repair the underlying pathology that leads to the prolapse- the symptom of the disease is treated and not the cause. A negative experience is if repeat surgical attempts are necessary- a procedure that is needed in a high percentage of patients. This secondary corrective surgery is to be done against the background of tissue damage and scarred tissue. The patient is at best worse off than what she had been before the primary surgery. The undo factor is hampered by scar tissue formation and at times depleted tissue. Especially the re-do aspect of surgery is challenging – shall one do the same procedure again or shall it be an alternative method? Even today this procedure is seen as the basis of pelvic organ prolapse surgery- maybe an admission that we fail as pelvic floor surgeons?

No wonder that “innovative“ avenues of pelvic floor surgery is being explored. In most of these pelvic organ support is being created by the introduction into the pelvis of different kinds of grafts and mesh implants. The basis of these surgical procedures in the anterior vaginal wall is to release the anterior vaginal support from its lateral sidewall attachments to the white line and the attachments to the central cervical ring. An indirect support system is created by bridging the gap from white line to white line, posterior aspect of the pubic rami to interspinous space with a xenograft graft or mesh of synthetic materials. This is claimed to correct the anterior vaginal wall defect in most of cases. The procedures are simplified to make incompetent surgeons more competent. Unfortunately do this lead to an increasing number of reports of complications- in most cases leading to corrective surgery and even removal of the placed materials. The undo re-do factor- especially the undo part- in these cases is high leaving the patients worse off compared to what they had been before the primary surgery. To re-do one need to follow a new avenue of surgery- a subject on which not much is written.

The complications caused by the synthetic meshes are subjected to classifications to understand it better, or to deal with them better- this is the new science of pelvic organ reconstruction surgery! To counter the negative effects of the synthetic meshes the material is either interwoven with dissolvable materials, or the holes in the mesh is made bigger. This is to minimize the structural damaged the placed mesh material can do. Questions can be asked if this really is constructive surgery, especially if one need to restrict the collateral damage or potential destruction it can cause.
The inflammatory response to the synthetic material has an ongoing component. As time goes by this leads to an ever increasing scarring and thus a tendency for shrinkage/constriction and pain. It does not make surgical sense to put a material like that between two hollow organs. The placement is also recommended to be in the intervening space between the bladder and vagina (vesico-vaginal space- VVS) and the space between the rectum and vagina (recto-vaginal space-RVS). This bring the material in direct contact with the bladder or rectum wall- two organs into which the synthetic material can erode with disastrous consequences. The obliteration of a space between two independently moveable organs will have a influence on function. Removal of this material (undo) takes special talents.
Then one still have to deal with the re-do factor.

Is it not time that the use of synthetic materials in anterior vaginal wall reconstructive surgery must be seen as a surgical experiment that failed?

The first option leave the patient without building blocks for future surgery and option two can leave the patient scarred for life. Some surgeons see option two only viable if option one failed- in itself an admission of failure as true constructive surgeons. The patient must earn her way into the use of synthetic materials!

The author is currently exploring a third option for anterior vaginal wall surgery. In a structured reconstructive approach a set of requirements are laid down for the primary surgical procedure.

This will include the following:
1. Secure the vaginal apical support
2. Side and site specific suturing of damaged anterior vaginal support
3. Site specific suturing of posterior vaginal wall
4. Bolstering of the anterior and posterior wall primary repairs- this provide a splint for the primary suture lines and, if a non-cross linked xenograft is used, a template for in growth of young collagenous tissue.
5. The normal anatomy is used as a template and all efforts are made to recreate this and not to create new “innovative” anatomy. Special emphasis is put on improving the collagen content of pelvic organ support.

Over the past 4 years a specific technique could be adopted following a process of continuing surgical auditing. A colposuite theatre setting – comparable to the endosuite system in endoscopic surgery- is developed where all vaginal surgery is done under camera control and visual guidance. All procedures are video taped and stored on DVD’s- this enables one to look back on specific procedures where either good or poor results were found. All this is done with ethical committee approval and patient consent. Procedural defects could thus easily be detected and corrected. Results were assessed on a 6 monthly basis before any adjustment in technique is done. Surgical outcomes will be reported when sufficient cases over at least 2 years post operative follow-up can be assessed. In the past 18 months a constant technique -developed through this process- is adopted and done on all cases with anterior vaginal wall prolapse.

All vaginal procedures were done with either the Lone Star Retractor System (Lone Star medical Products, Inc) or the TLC retractor system (AMT, Inc) in place. Knowledge of the different layers in the vaginal wall which are cleaved with surgery is essential. No dissection is done into either the vesico-vaginal space or the rectovaginale space, keeping not only these intact, but also staying away from direct contact with the bladder or rectal wall. The use of xenograft material is an integral part of this approach. Placing of grafts is limited to non-cross linked xenographs and these are only placed at or near the normal fascial layers, enabling the graft to harvest host collagen. Stay sutures are placed on the pelvic sidewall at or near the ischial spines on the arcus tendineous fascia pelvis (whiteline)- these are used to anchor the bladder base onto the whiteline. If plication is necessary, it is done with these plicating the bladder base laterally. This side specific approach indirectly corrects the prolapsed anterior wall, without compromising the bladder base (compare this to the direct plicating of the bladder base with the classical approach). The high transverse defect is corrected with 3 sutures pulling the base of the bladder onto the cervix anteriorly- the site specific part of this repair. Only delayed absorbable suture material (Maxon 0) is used. The xenograft is loosely laid onto the defect, tied to the white line with the lateral sutures used to support the bladder base and plicated to the whiteline and to the cervix, creating a ridge of Xenograft running from ischial spine to ischial spine- thus creating a new anterior peri-cervical ring. No vaginal skin is trimmed and a hysterectomy is done only if the uterus is pathological. The technique is referred to as Vaginal Side and Site specific Repair (VSSR).

Initial results showed that 6,5% of VSSR needs post operatively corrections. This technique leaves building blocks if secondary surgery is needed and, more importantly, scarring is limited. With suboptimal results there is basically no undo needed and the re-do is usually limited to resuturing of seams that came loose. The re-do is usually a day procedure with limited morbidity.

This approach is a structured staged approach to surgery –comparable to the plastic surgeons’ approach when reconstructing damaged organs

In the two groups of patients most neglected in prolapse surgery, namely the very young women with prolapse and the patient who had suboptimal results, this method can be a way out of the dilemmas. The reason why any gynaecologist is vary to operate on the young woman with symptomatic prolapse is the awareness that the classical repair gives not only poor long term results, but also result in tissue damage with a high incidence of concomitant hysterectomy risk. The use of synthetic material in the vaginal wall of a young patient is for obvious reasons not an option. A more structured approach to prolapse repair can be a viable option for them. The re-do of failed previous repairs can also be done in a structured constructive manner- be it by repairing the underlying pathology (in a side and site specific manner) and bolstering it with a collagen graft, or by bridging the gap left by the undo process with a non-cross linked bio graft. In this re-do group of patients one obviously need to motivate why one did not do the primary surgery in a structured constructive way in the first instance.

The surgical procedure one do is dependent on various factors- mostly by what is perceived as your surgical comfort zone. This is created by your teachers and own experience. To change this comfort zone take special care. The do no harm effect of the chosen surgical procedure must always be the focus point, with the help aspect the final parameter. A balance between the two is essential.

It is time that we as reconstructive surgeons do just that- reconstructing. In helping the patient one tends to forget the amount of harm that can be done. Let’s be proud of the surgical footprint we leave behind. A more structured constructed approach in the primary surgery can help towards that goal.

This article is published in an abreviated form here: