Gabriele Naldini1 and Claudia Menconi
Department of Gastroenterology, Proctological and Perineal Surgery Unit, University Hospital, Pisa, Italy
Discussion of the prevention and treatment of complications of surgery for pelvic floor disorders is particularly challenging because there are many reports of complications in the literature, but very few references to the possible causes and how to avoid and manage them.
Discussion of the prevention and treatment of complications of surgery for pelvic floor disorders is particularly challenging because there are many reports of complications in the literature, but very few references to the possible causes and how to avoid and manage them.
The literature usually reports the final result of these complications (stoma, Hartmann’s procedure, etc.), but this does not help the surgeon to choose of the correct therapeutic strategy when there is a problem to solve.
Often, considering the potentially serious complications of pelvic floor surgery, some surgeons can be critical about the indications for surgery because pelvic floor disorders are benign diseases.
Anyone with knowledge of the functional pathology of the pelvic floor knows that problems of constipation or incontinence can be devastating in terms of the physical and psychological wellbeing of patients, resulting in a poor quality of life.
We must give the patient accurate information on the potential of the procedure to heal them, together with a careful description of possible postoperative problems.
Our opinion is that the colorectal and pelvic floor surgeon should become very familiar with this type of surgery, and that it should be offered to the patients to relieve their discomfort .
In each topic discussed below, the possible prevention of complications will be addressed, from technical and indication points of view, along with the intraoperative management of the patient, and the postoperative and possible negative sequelae of surgery.
23.2 Fecal Incontinence
The most feared complication of sphincteroplasty is wound infection , because it can cause dehiscence of the suture muscle, resulting in poor function results , and it may result in a rectovaginal fistula . At the same time, a diverting stoma does not improve the results of the operation, but increases the morbidity related to the stoma itself . A stoma is usually recommended in cases of complications or after further attempts to repair the sphincter [4, 5].
Intraoperative care should consist of: (1) performing the section on the muscle directly in the scar area without removing it completely, but incorporating it in the suture so as to give better stability to the suture; (2) avoiding excessive isolation of the stump muscle in order to reduce the possibility of devascularization or denervation.
If anal ultrasound and intraoperative appearance show that the section of the sphincter does not appear to be complete, a sphincter placation should be carried out to reduce the rate and severity of complications.
Although there is no evidence in the literature, it is very likely that in the majority of patients who show poor functional results after surgery that there could be a partial or complete dehiscence of the suture . There are very few studies showing a correlation between endoanal ultrasound examination and dehiscence of sphincteroplasty and poor results .
23.2.2 Sacral Neuromodulation
Sacral neuromodulation (SNM) is currently the first surgical treatment of choice after medical therapy and rehabilitation for medium-to-severe fecal incontinence. This is because it is minimally invasive, it can be used for a large number of indications, and it produces excellent results; these are among the main features that make it preferable to other surgical methods.
We believe it is necessary to point out two aspects that should be better defined in the literature. The first is the term ‘sphincter defect’, which is too generic and has led to lesions extending up to 180° being included for treatment by SNM. It is very difficult to believe that anatomical alteration of a sphincter defect that involves the entire anal canal to 180° may benefit from treatment with SNM.
The second aspect is the outcome judgment criteria for the decision to perform a permanent implant. The success criterion for SNM is considered to be an improvement in fecal incontinence of greater than 50% for 50% of the day. We believe that this judgment criterion does not show a true improvement in quality of life.
The technique for implantation of the electrode is simple, but there may be potential problems. The literature reports complication rates of 21.6–22%, with 33% of patients requiring surgical revision [8, 9]. The most important problems after implantation are pain at the implant area, infection, and the displacement of the electrode.
In order to prevent complications of the procedure, it is important to remember the following: (1) it is a prosthetic procedure, which requires maximum sterility despite the fact that the operative field may involve exposure of the anus for the visualization of the motor and sensory response; (2) all steps of the procedure should be performed under X-ray control in order to reduce positioning errors; (3) it is important to be very careful during the procedure, especially with thin patients, because there is the possibility that, however correct the positioning of the electrode (confirmed by X-ray during the procedure) part of the anchoring tines and their respective protective cover could be positioned outside the sacral fascia, generating dangerous subcutaneous electrode corners which can cause displacement, breakage or pain. (Fig. 23.1); (4) to avoid breakage of the electrode, close attention should be paid to the angles, especially in the area of the electrode where the lining of the anchor tines finishes. We have noticed that it is in this area that the electrodes may break because of the angle of the electrodes (Fig. 23.2).
The position of a quadripolar electrode in the third sacral foramen and the anatomical structures around it
An implanted tined lead broken during the removal procedure
Treatment of complications of SNM should be as follows: (1) in cases of infection at the area of the electrode, removal of the electrode is recommended to avoid major problems; (2) in cases of pain, assess whether it persists after stopping stimulation, and whether it disappears after reprogramming the stimulation; (3) in cases of electrode breakage, which is characterized by loss of efficacy and increased impedance, the electrode must be replaced and the same foramen can be used without any problems.
Contrary to what one might think, a critical step is the removal of the electrode for inefficacy or rupture. The literature describes an important hemorrhagic complication for which the patient was taken to the operating theatre twice for packing at the site of the sacral foramen, transfused, and then discharged after 32 days . There are also many reports of rupture of electrodes that remain in the area of the sacral foramen; this outcome, especially from a medicolegal point of view, could be a major problem because the patient has a foreign object that has been left in the body after the failure of the procedure. This is especially important because an abdominopelvic MRI cannot be performed on these patients. In such cases, it is recommended that the surgical access area is enlarged to try to identify the distal stump of the electrode so that it can be removed. In cases of electrode failure, there are no reports in the literature indicating that it should be removed with a neurosurgical approach.
23.2.3 Bulking Agents, Dynamic Graciloplasty, and Artificial Sphincter
Bulking agents have been shown to have low levels  or no morbidity . However, some cases of foreign body granulomas have been described after the use of bulking agents . A risk factor for local complications is the presence of multiple scars from previous surgery, for example for an anal fistula, or the presence of active perineal sepsis, even if it is subclinical. Dynamic graciloplasty (DGP) has a very high morbidity rate (69%) ; revision surgery, involving the removal of electrodes and implantable pulse generator, is necessary in around 22% of patients. In the use of an artificial bowel sphincter (ABS), removal of the device because of ulcers, sepsis, or ineffectiveness occurs at rates ranging from 37%  to 46% .
When taking these points into consideration, we believe that DGP or ABS should be considered as rescue procedures, and proposed only to patients that have no surgical options other than a permanent stoma.
23.3 Obstructed Defecation
23.3.1 Stapled Transanal Rectal Resection
Stapled transanal rectal resection (STARR) is the most talked-about technique that has been proposed in recent years, because of its revolutionary etiopathogenetic aspects and also because of commercial support. The liveliness of discussions on STARR in scientific circles has led to a increase in knowledge about the procedure. Unfortunately, in the world of the coloproctologist, there are those who see only advantages and good results for the procedure, and those who see only complications. The surgeon should be able to appreciate the excellent results produced by the technique and work out how to reduce possible complications. The complications of STARR are discussed below.
220.127.116.11 Anal Pain
To prevent anal pain, patients who have preoperative symptoms of anal or perineal pain should not be subjected to the procedure. Pain is not a typical symptom of rectocele or prolapse, therefore it is risky to operate on a pelvic floor that has an unknown or other source of pain because this procedure will possibly aggravate it.
If the patient still has significant pain 3 or 4 weeks after the operation, especially if it is on the suture line and the pain was not present before surgery, the cause is most likely due to the staples or the hemostatic stitches, which have probably involved, even if only superficially, the underlying musculature. It should be remembered that the correct level for the sutures is usually at the height of the puborectalis sling and if this involves the underlying muscle or if there is excessive fibrosis under the suture it could fix the rectum to the floor below. If this happens, the typical continuous pain is made worse by defecation. The surgeon must be able to recognize if the cause of the patient’s problem is the surgical procedure itself, and must therefore endeavor to resolve it.
Our approach in cases of pain on the suture line is aggressive, with reintervention and removal of most of the suture line, in particular the part of the suture that is most sore and which generally corresponds to the least mobile zones on the underlying tissues.
The continuity of the mucosa should be restored by suturing with absorbable stitches. In our experience (18 cases that have not yet been published), we were able to achieve complete pain resolution in more than 75% of patients using this treatment. This percentage is reduced to less than 48% if the same procedure is performed more than 2 months later. It is essential to make sure that the pain does not become chronic. In clinical practice, we have not found any benefits in the treatment of chronic pain by removing of only some of the staples, as has been described by other authors .
In the first few weeks after surgery, if the patient reports that the anal pain is resistant to standard analgesic therapy, the use of neuromodulation drugs such as pregabalin or gabapentin may be helpful. It might also be helpful to consult an anesthesiologist who specializes specifically in the treatment of pain. In our experience , which is different from other authors , we have had only a few good results in the treatment of pain with SNM after a STARR procedure. We judge a medical failure to be the need for a permanent SNM implantation for pain after the surgical procedure.
18.104.22.168 Anal stenosis
To prevent anal stenosis, avoid sutures that are clearly too low, as well those that are clearly too high. High sutures predispose to stenosis, causing a rectal hourglass shape, and this stenosis interferes with the dynamics of feces expulsion. In practice, the suture level should always fall just above the apex of the hemorrhoidal tissue.
In our experience, we have used all types of staplers available on the market to perform STARR. Stenosis has been found to occur using all types of staplers, including the CCS-30. A trigger for stenosis can be the presence of preoperative proctitis or the occurrence of diarrhea with tenesmus after surgery. The type of staples used might be another factor to take into account: when comparing staples made of pure titanium with those made with titanium alloy, the majority of inflammatory responses were found to be to the alloy .
Since anal stenosis is a mechanical anastomosis, it is extremely rigid and does not respond to dilatations with anal dilators or pneumatic endoscopic dilations.
For treatment of anal stenosis, it is advisable to operate again and remove as much as possible of the suture line. Following this, it is necessary to maintain the caliber with mechanical dilatation in combination with transanal mesalazine.
22.214.171.124 Pararectal Hematoma
This is a very dangerous condition because it can also be the cause of further complications such as anastomotic dehiscence, delayed bleeding, or perineal sepsis, which are all equally serious complaints.
Prevention involves the correct choice of and use of the stapler. Because of the full thickness of the anastomosis, it will always include a large amount of mesorectum, and for this reason it is essential to use staplers with correct capacity. Although there have been no complications reported in the literature , we consider it extremely risky and wrong to use a stapler with a locking mechanism in the range 0.75–1.5 mm to perform a full-thickness rectal resection. The problem is not with the intraluminal tissues, but with the extraluminal tissues. Also the continuity and speed of the closing action of the stapler should be observed carefully; an unstable closure (a two-step closure) may cause the blade to damage the tissue before complete closure of the staples. This can result in an incomplete suture.
There are no reports in the literature on treatment for pararectal hematomas. Our approach toward this type of complication comes from years of experience and from discussion with coloproctologist colleagues who believe and encourage this type of technique (what type of technique?), while continuing their efforts to overcome possible complications. It is important to differentiate between stable hematoma and active hematoma in patients who are hemodynamically unstable .
126.96.36.199 Stable Hematoma
This should be treated with broad-spectrum antibiotics, total parenteral nutrition, and spontaneous drainage, which is normal for a minimum suture dehiscence in the third/fourth day after surgery, with gradual drainage of the hematoma cavity. If symptoms such as abdominal pain or failure of bowel canalization persist 3–4 days after surgery, it can indicate the need to perform a minimum transanastomotical opening by the transanal route so as to permit spontaneous drainage. It is important not to drain the hematoma too early, or debride and clean the cavity by washing it with antiseptic solution. Hematomas are usually very large and come up to the rectal peritoneum, and often produce an inflammatory reaction with the appearance of free fluid in the abdomen. Emptying the cavity means risking the rectal lumen coming in contact the peritoneum, a source of bacterial contamination. The presence of air in the hematoma and in the perirectal fat is due mostly to the passage of air from the rectum to the dehiscence, and not to gas gangrene, which would result in more severe symptoms. Our advice is to put a soft drainage tube into the rectum to allow the spontaneous outflow of air.
188.8.131.52 Progressive Hematoma
In cases of progressive hematoma, wait, if possible, for stabilization of the framework through transfusions of blood and plasma. In our experience, derived from emergency surgery, the majority of retroperitoneal hematomas resolve themselves. Embolization by use of angiography is recommended and is efficient for those patients with unstable hemodynamics (Fig. 23.3). In women, it could be useful to use a gauze laparotomy packing through the vagina, associated with the positioning of the Sangstaken-Blakemore probe in the rectum. An aggressive laparotomy should be the very last resort, because, in the presence of a large hematoma, it is impossible to perform dissections that lead to selective hemostasis, and it might then be necessary to resort to a major procedure such as Hartmann’s resection.
Angiographic embolization for an unstable pelvic-perirectal hematoma
184.108.40.206 Rectovaginal Fistula
This is a technical error that should be avoided if possible.
In order to prevent the occurrence of a rectovaginal fistula, the correct positioning of a vaginal valve is necessary at the beginning of the procedure, so as to support the cervix, vaginal vault, and possible enterocele; the positioning of this valve stretches the rectum and the retrovaginal septum, which become more visible and can be checked easily with a digital maneuver.
In our opinion, it is unlikely to consider a rectovaginal fistula as being secondary to a hematoma drainage, considering the solidity of vagina wall. We think that a hematoma in this area would drain more easily through the rectal anastomosis rather than into the vagina.
Treatment of a rectovaginal fistula is not as simple as it is reported to be in the literature. The preparation of the reconstruction usually leads to a large gap because all of the staples must be removed in the area where the rectum will be repaired. In our opinion, it is extremely difficult to be able to mobilize a rectal flap that is adequate after a STARR procedure that has resected at least 5–10 cm from the rectum. In large resections using CCS-30 (Transtar), the risk is to involve the pouch of Douglas in the suture; for this reason, during the isolation of the anastomosis there is a risk of entering the peritoneum with problems of bacterial contamination.
220.127.116.11 Rectal Necrosis or Perineal Sepsis
In cases of rectal necrosis or perineal sepsis, an aggressive approach with a stoma or resection using Hartmann’s procedure is indicated, in order to avoid deterioration of the clinical state of the patient, and possibly death, as described in the literature .
When opening a rectum with an intraoperative dehiscence, it must be completely repaired intraoperatively without a stoma. The surgeon must be able to perform a manual transanal anastomosis. This situation can be particularly difficult to correct if it happens during the use of a CCS-30 because the resection is larger, and also there will be more intersection of the sutures. The presence of tangential vectors on the intersection of sutures increases traction on the sutures. A tear of the anastomosis may be very difficult to resolve during the use of a CCS-30 stapler.
18.104.22.168 Urgency and Fecal Incontinence
This is the main problem with which we are confronted in the postoperative period after STARR. This potential problem should be clearly explained to patients and they should be asked to sign a detailed informed consent. Strangely, literature reports indicate that preoperative incontinence improves after a STARR procedure. We believe that it is very dangerous to use STARR on a patient with incontinence, especially if is active, as it is almost certain to be worse postoperatively and at the 1 year follow-up.
In the literature, fecal urgency is said to occur in around 25.3%  to 34%  of patients who undergo STARR; however, there is a problem in actually defining the term defecatory urgency. This condition should include those patients in whom the stimulus has become more urgent, but the patient is able postpone defecation until the appropriate time and place. If this is not the case, then the patient should be considered to be incontinent.
The only currently available manometer data [25, 24] correlate the trouble with continence with a reduction in compliance. In our experience, these problems can benefit from treatment by pelvic floor rehabilitation, particularly volumetric rehabilitation or SNM .
23.3.2 Internal Delorme’s Procedure
This is an alternative technique to STARR, and it is technically more difficult to perform. Intraoperatively, it can be difficult to keep the muscle layer intact, and there is a danger of entering the perirectal fat, with the possibility of infection. It is difficult to decide how much rectal mucosa to remove and how much to plicate, because plication of more than 8 cm of rectal muscle can seem excessive.
Bleeding and stenosis are among the possible complications that have been reported. In the literature, and incidence of complications can vary from absent to 34% . Stenosis is formed at the level of the cylindrically plicated rectum and treatment involves the removal of a large fibrotic labrum, which results in the anastomosis regaining elasticity. From the point of view of defecatory and urgency incontinence, possible complications are similar to those that apply to STARR; the only difference is that with an internal Delorme’s procedure there is an elongation of the anal canal, and therefore fewer potential problems, especially problems with passive incontinence (G. Naldini and C. Menconi, unpublished data).
23.3.3 Laparoscopic Ventral Mesh Rectopexy
In recent years, laparoscopic ventral mesh rectopexy (LVMR) has emerged as the preferred method for rectopexy. In the literature there are controversial results about functional evaluation of rectopexy. Some authors compare patients with external prolapse with patients with rectocele and rectal intussusception, and then evaluate the functional results and judge a positive result to be an improvement of 50%  in constipation [29–32]. Since constipation is the most important, if not the only, indication of rectal intussusception, we find this enthusiasm hard to share. A recent, extremely interesting, publication reports on ways to deal with complications of LVMR, in the setting of a tertiary referral center .
All dissections should be performed with hook diathermy. If the mesh needs to be replaced, a Teflon-coated lightweight polypropylene is recommended, and if it comes off it is best to use a new mesh anchoring it to the sacral promontory with Protacks, and suture it to the mesh previously placed. In cases where there is a lesion in the rectum, it can be sutured if it is small, or an anterior resection of the rectum with limited LVMR using a biological mesh above the anastomosis can be performed. For rectovaginal fistulas, the mesh can be removed laparoscopically, and the rectum repaired through an abdominal access if it is high, or transvaginal if it is low. All other erosions should be treated with laparoscopic removal of the mesh, by repairing the defect and by repositioning the biological mesh.
The causes of LVMR failure can be: absence of ventral dissection and mesh lying free on the pelvic brim; or the recurrence of a prolapse, in which the cause is detachment from the sacral promontory or the incorrect positioning of the staples on the top of the sacrum rather than the promontory (in most cases only two staples were found to have been used).
Complications caused by the mesh can be: stenosis of the rectum due to the attachment of the thread of the mesh to the midsacrum instead of the promontory; erosion of the rectum or vagina, which is treated by the removal of the mesh, and repair and positioning of a biological mesh; pelvic pain as a result of an excessive inflammatory response to the implant, and this can be treated by replacement of the prosthesis with Teflon-coated polypropylene, which shows good results.
Interestingly, the 2008 National Institute for Health and Care Excellence (NICE) review  indicates a much higher rate of erosion for synthetic meshes compared with the organic meshes; in contrast, the percentage of failures is substantially higher (23% vs. 9%) than for organic meshes. We advise using a laparoscopic approach and not a perineal approach to remove the mesh, because the perineal approach can be very difficult technically.
There are still questions for which there are no answers in the literature. (1) In cases of permanent or worsening constipation that do not show any problems of a technical nature, is there anything that can be done? (2) Are there any effects of LVMR on possible pregnancies in women of childbearing age? (3) In cases of rectal cancer (especially if it is anterior), could it be a problem to have a prosthesis between the rectum and vagina just above the pelvic floor?
The treatment of complications is always very difficult and they often become chronic disorders for the patient. The best approach is prevention of complications through accurate diagnosis and choice of procedure and device. Again we point out the importance of choosing the best device and in-depth knowledge of the characteristics of the device. The cause of possible problems and complications can be insufficient knowledge of the device.
Our advice is to perform surgery only if it is able to resolve the complications. We regret that we have had to underline the fact that the literature is of little helps to us in the treatment of complications; it appears to indicate that whatever procedure you perform produces good results, and this is absolutely not true.
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