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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 42 | Complications of Dynamic Graciloplasty [2001년 10월 DCR] | 2011-11-17 | 3507 |
|
Incidence, Management, and Impact on Outcome
Klaus E. Matzel, M.D., Ph.D., Robert D. Madoff, M.D., Laura J. LaFontaine, B.S. Cot G.M.I. Baeten, M.D.
From the Department of Surgery, University of Erlangen-Nurnberg, Erlangen, Germany, Department of
Surgery, University of Minnesota, Minneapolis, Minnesota, MedtroniG Inc., Minneapolis, Minnesota, Academic Hospilal Maastricht, Maastricht, the Netherlands, IIDepartment of Surgery, University of Calgary, Calgary, Canada, Surgery Department, Herlev Hospital, University of Copenhagen, Denmark, Department of Colon & Rectal Surge,35 Cleveland Clinic Florida, Weston, Florida PURPOSE: Dynamic graciloplasty can improve continence in paticmts with severe refractory fecal incontinence, but associated morbidity is high. The purpose of this study was to identify complications associated with dynamic graciloplasty and to characterize their treatment and impact on patient outcome.
METHODS: In 121 patients enrolled in a prospective trial of 20 centers and eligible for safety analysis,
all complications of dynamic graclioplasty were recorded at the time of their occurrence and followed up until resolution. Severe treatment-related complications were defined as those requiring hospitalization or surgical intervention. RESULTS: In 93 patients, 211 complications occurred. Of these, 89 (42 percent) in 61 patients were classified as severe treatment-related complications and resulted from the following: major infection, 19; minor infection, 10; thromboembollc events, 3; device performance and use, 13; pain, 16; noninfectious gracilis problems, 8; noninfectious wound-healing problems, 3; other surgery-related complications, 3. In addition, severe treatment-related complications resulted from constipation in ten and stoma creation or closure in ten. The recovery rate (flail or partial) was 87 percent overall, and for severe treatment-related complications, was 92 percent. Of the types of complications, only major infections had an adverse effect on outcome. CONCLUSlON: Severe complications occur frequently after dynamic graciloptasty, but are usually treatable. They often require one or more reoperations and can lead to significant delays in completion of therapy. In most cases therapy can be salvaged.
Dynamic graciloplasty (DGP) for severe fecal incontinence is an autologous sphincter replacement,
which, under electrostimulation, simulates natural bowel control. The procedure involves transposition of the gracilis muscle from the inner thigh to around the anus and implantation of electrodes (connected to an impulse generator (IPG)) into the transposed muscle. In end-stage fecal incontinence it offers a therapeutic alternative to colostomy. Several single-center and recently published multicenter studies have reported success rates of 56 to 73
percent. However, associated morbidity is high, potentially leading to functional failure and challenging broader acceptance of DGP as a surgical option. The efficacy of DGP, assessed by a prospective multicenter trial, has been reported previously. The
present report, based on the 'same multicenter trial, focuses on safety. Our purpose was to identify associated complications and the probability of their occurrence, ascertain the frequency of severe complications, characterize their management, and assess their impact on therapeutic outcome. DISCUSSION
In this study, as in others dynamic graciloplasty was associated with high morbidity'. Although a variety
of factors conutribute, the procedure itself is important. Technically not unduly complex, it nevertheless represents an exacting combination of muscle transposition and the implantation of a foreign body in a naturally contaminated site, thus carrying an inherent risk of infection. The compIications observed in this study, mostly occurring in the 30-day postoperative period (53 percent) and mostly graciloplasty-related (72 percent), were similar to those previously reported and most commonly included infection, pain, and those related to device use or performance. The percentage of patients recovering fully was greater in those whose complications were related to the device than to the graciloplasty procedure, but neither this nor median time to resolution was significantly different. Of all complications, surgery or hospitalization was required for 42 percent.
The most dramatic complication was death in one patient from pulmonary embolism. Because DGP involves a lower extremity; a known risk factor, and often requires longer than one hour, careful patient selection and appropriate prophylactic measures are crucial.
The one complication most often resulting in an adverse effect on outcome was major infection, mostly
(47.4 percent) as a sequela of the graciloplasty in the immediate postoperative period and caused by anal canal perforation or early anal canal erosion. It is possible the early erosions may have followed small, unrecognized intraoperative perforations created during graciloplasty. Because creation of the anterior tunnel is the most difficult part of the operation, especially in patients with scarring from previous trauma, an extra incision in the back wall of the vagina may be advisable. .Meticulous attention to surgical tectmique in the naturally contaminated operative field and application of antibiotic sponges may further reduce the risk of infection. Potential risks of the graciloplasty procedure are inadequate fixation of the transposed muscle, leading to
tendon detachment (the most common noninfectious graciloplasty event in this study), and a tendency to make the wrap too tight, increasing the risk of anal canal perforation with subsequent infection (seen particularly in centers new to this technique). Two cases of tendon erosion through the anal canal did not lead to infection, probably because of a preexisting stoma. In contrast to most of the other complications, most device performance and use events occurred during
the follow-up period, rather than in the early postoperative course, and were slow to resolve, particularly because the full extent of the problem was not readily apparent. The most frequent complications--lead dislodgment and other lead problems--are being addressed by a modification of the lead design. Neurostimulator migration presented a less frequent device problem. Securing the implanted neurostimulator to the tissue with nonabsorbable sutures through the suturing holes and placing the neurostimulator under the rectus fascia rather than subcutaneously (or educating the patient to avoid twisting or twiddling the neurostimulator if placed subcutaneously) may minimize the potential for device migration or use problems after implant. Device-related pain complications were mostly related to the site of implant (12 of 28), with 7 of these 12
responding to surgical repositioning. In this study the neurostimulator was typically positioned in the lower abdomen. To minimize the potential for device-related complications, one should avoid placement near bony structures such as the rib or iliac crest, interview patients before implantation to identify and mark the optimal location, use the suturing holes to secure the neurostimulator to the tissue, place the IPG underneath the fascia ff possible, and reprogram the device when necessary, using unipolar stimulation modes. The most frequent pain complaint reported was pain in the donor leg. This may be attributable to two
reasons: perception of a sore transposed muscle at its natural position; and actual trauma to tissue and nerve structures near the harvest site. Careful dissection of the muscle from surrounding tissues and avoidance of skin incision at the tuberositas tibiae should be considered to limit trauma, whenever technically feasible. In this study a broad spectrum of symptoms has been summarized under "constipation complaints":
infrequent defecation; passage of small stools; absence of urge; prolonged straining on defecation with or without pelvic floor relaxation; perineal pain associated with prolonged contraction of the pelvic muscles; defecation requiring digital evacuation; impaction owing to lack of urge; abdominal bloating; and sensation of incomplete emptying. When considering constipation complaints in patients with fecal incontinence, it is worth remembering that mild constipation, depending on how it manifests itself, may not be considered an undesirable outcome. Given the broad definition of constipation, patients may complain even when they are having daily bowel movements or, in incontinent patients, daily, accidents to stool. Underlying constipation or evacuation disorders may have been baseline conditions for study patients, masked by the presence of incontinence but arising again once the sphincter deficit was addressed with DGP and anatomical stenosis of the anal canal secondary to graciloplasty excluded. Adequate patient selection, focusing on a preexistence of slow-transit constipation or defecation disorders, wilt be of foremost importance to avoid morbid constipation after DGP. The surgeon's experience with the procedure has been reported to be an important factor influencing
the morbidity rate of DGP, but our data do not support this observation. Neither the number of the DGPs performed previously nor the experience gained with the procedure during the course of the study was revealed to have an influence on the morbidity rate. Bearing in mind that, in all participating centers, surgeons not experienced with this technique underwent training before their first procedure or performed their first procedure with an experienced surgeon present, one can assume that the observed morbidity rate adequately- represents the risks. The high morbidity rate observed in our study must be weighed against that of a permanent stoma, the traditional surgical option for end-stage incontinence. For colostomy, the morbidity rate is reported to be approximately 50 percent, with a reoperation rate of 15 to 20 percent and declining success with each subsequent procedure. In addition, colostomy provides stool control rather than continence and is associated with negative psychological consequences. |
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