Abstract
Objective:
To compare laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomized case-controlled prospective study of consecutive patients with parastomal hernia.
Background:
Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.
Materials and Methods:
In two time periods, 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and polytetrafluoroethylene [ePTFE] with a self-cut slit, 1997–2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009–2015). The patients in the two groups matched with regard to clinical profile, colostomy or ileostomy hernia, previous repairs, size of fascial defect, and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma resiting, mesh removal, death, or last nonevent visit.
Results:
In-hospital morbidity did not differ with two fatalities in each group. Seventy and fifty-eight patients after Keyhole and Sugarbaker repair, respectively, were available for follow-up. Two patients after Sugarbaker repair were lost to follow-up. After a median follow-up of 57 months, five recurrences were diagnosed in the Keyhole group (7%). In the Sugarbaker group, six recurrences (10%) were observed after a median follow-up of 11 months. Late mesh-related morbidity occurred in 6 and 6 patients after Keyhole (8%) and Sugarbaker repair (10%), respectively.
Conclusion:
The present study indicates that the Keyhole repair, using a polypropylene mesh with an antiadhesive layer, compares favorably with the Sugarbaker repair with regard to postoperative complications, recurrence rate, and late mesh-related morbidity.
ClinicalTrials.gov Identifier:
NCT 0418 7235.
Introduction
Despite lack of evidence from controlled trials, laparoscopic repair of parastomal hernia has gained increasing acceptance. It is generally agreed that the outcome after open repair is poor, in particular after a nonmesh repair. A restrictive attitude to use a mesh at open surgery in the presence of an ostomy has probably contributed to the change in favor of laparoscopic repair.
According to published studies, two methods of laparoscopic repair prevail, the Keyhole repair and the modified Sugarbaker technique.
At present, there are a number of nonrandomized studies, claiming that the Sugarbaker repair is the laparoscopic method of choice.1–9 In two reviews, it was concluded that the Sugarbaker approach was superior to the Keyhole repair.10,11 The authors, however, failed to extend their analysis to what mesh that has been used in studies reporting high recurrence rates after the Keyhole repair. Their conclusion, therefore, may be challenged.
While randomized-controlled trials are absent, the present study of consecutive patients aims to compare the Keyhole with the Sugarbaker repair in a nonrandomized setting, performed in two periods of time with focus on long-term recurrence and late mesh-related morbidity. We have previously reported the outcome after the Keyhole repair. 12 In the present study, additional patients with a Keyhole repair have been included and the follow-up is substantially longer.
Materials and Methods
Laparoscopic mesh repair was commenced in 139 consecutive patients with an end-colostomy or end-ileostomy. The procedure was converted to open repair in 3 patients with intended Keyhole repair and in 1 patient with intended Sugarbaker technique. The reason was inaccessible abdomen due to dense adhesions after previous open surgery.
Of 135 patients with completed laparoscopic mesh repair, 74 patients underwent a Keyhole repair (1997–2009), and 61 patients had a Sugarbaker repair (2009–2015). The profile of the 135 patients is listed in Table 1. Perioperative and follow-up data were prospectively collected and stored in a specifically designed database (www.itsosimple.net). There was no statistically significant difference between groups when comparing gender, age, American Society of Anesthesiologists score, and colostomy versus ileostomy (Table 1). In the Keyhole group, 25 patients had a history of parastomal hernia repair. The corresponding number of patients undergoing Sugarbaker repair was 15 patients. Repair of a concurrent incisional hernia was performed in 14 patients in the Keyhole group and in 12 patients in the Sugarbaker group (Table 1). All operations were performed by an experienced colorectal surgeon (P.W.) or under his close supervision.
Profile of Patients with Keyhole and Sugarbaker Repair of Parastomal Hernia
ASA, American Society of Anesthesiologists; ePTFE, expanded polytetrafluoroethylene;
Operative technique
The patients were placed in a supine position. The arm on the opposite side of the stoma was placed hanging over the head for improved instrumental access to the anterior abdominal wall. Prophylactic antibiotics were not routinely administered. Pneumoperitoneum was established at Palmer's point with a Veress needle. Three trocars were inserted laterally opposite to the stoma, using a 30° optic. Adhesiolysis was carried out with sharp dissection as close as possible to the abdominal wall without the use of thermal devices. If a seromuscular or full-thickness injury of the bowel wall was detected, the lesion was sutured, antibiotics were administered, and the procedure was carried on. Hernia content, if present, was reduced in the abdominal cavity. The edge of the parastomal fascia defect was freed circumferentially, leaving the hernia sac unresected. The diameter of the fascial defect was measured by a ruler. No attempt was made to close the fascial defect with a suture.
Keyhole repair
A two-layer mesh (median size 14 × 14 cm), consisting of polypropylene on the parietal side and a nonadhesive layer of expanded polytetrafluoroethylene (ePTFE) toward the viscera, was used in 72 patients. A 4–5 cm slit was cut in the mesh. At the end of the slit, a 1 cm circular hole was cut. With the slit at 6 o'clock, additional five small radial incisions of 1 cm were cut at 2, 4, 8, 10, and 12 o'clock, allowing space for the middle phalanx of the index finger. 12 In the presence of a bulky bowel segment, the radial incisions were extended a few mm to ensure a snug fitting. Covering the fascial defect, while aiming at an overlap of at least 3 cm, the slit in the mesh was placed laterally. In the remaining 2 patients, a 15 × 15-cm-coated polypropylene mesh was used, the same mesh used for the Sugarbaker repair, because the two-layer mesh was no longer commercially available.
The mesh was anchored with circular concentric titanium tacks spaced at 1–2-cm intervals at the edge of the mesh and an inner ring next to the fascial defect, taking meticulous care to reassemble the split laterally.
Sugarbaker repair
For the Sugarbaker repair, a lightweight polypropylene mesh (median size 15 × 15 cm) coated with hydrogel barrier was used. The antiadhesive barrier was based on Sepra Technology. The coated surface was placed toward viscera. It was aimed to achieve a mesh overlap of minimum 4 cm. The anchoring device and technique were the same as in the Keyhole group, with two concentric rings adding anchoring tacks on each side of the laterally exteriorizing bowel.
Follow-up
Patients discharged were invited for follow-up in the outpatient clinic after 3 months, 1 year, and 3 years. Subsequent to the third visit, the patients were contacted by telephone. In the presence of symptoms indicative of recurrence, they were invited back for an examination in the outpatient clinic. Diagnosis of recurrence was made by clinical examination. When in doubt, a CT scan with Valsalva maneuver was performed.
In patients living outside the referral area of Aarhus University Hospital, the electronic records from local hospitals were accessed, facilitated by the unique Danish Civil Registration Number, and checked for any reoperation due to complications or signs indicative of a recurrence.
Observation time was defined as time to recurrence, stoma resiting, mesh removal, death, or last nonevent visit.
Statistical analyses
Statistical analyses were performed using the statistical package SPSS 13.1. Comparisons were made using the chi-square test or the Fisher exact test when appropriate. Statistical significance was assumed at P < .05.
Results
The size of the fascial defect was the same in the two groups with a median diameter of 4 cm (Table 1).
Postoperative complications, observed in 11 and 7 patients after the Keyhole and Sugarbaker repair, respectively, are shown in Table 2. Inadvertent lesion of the bowel wall detected during surgery occurred in 8 patients in the Keyhole group (one full-thickness and seven seromuscular lesions) and in 4 patients in the Sugarbaker group (three full-thickness and one seromuscular lesion). The lesions were sutured with uneventful recovery. Two full-thickness bowel lesions, one in each group, were overlooked intraoperatively and resulted in general peritonitis and death (Table 2). One patient with a preoperatively undiagnosed portal hypertension died of hemorrhage after a Keyhole repair, while 1 patient with a Sugarbaker repair succumbed due to pulmonary insufficiency.
Postoperative Morbidity (within 30 days) in 135 Patients with Completed Parastomal Keyhole and Sugarbaker Repair
Some patients had more than one complication.
The median length of hospital stay was 2 and 3 days in patients with a Keyhole and Sugarbaker repair, respectively.
Because of 4 postoperative fatalities, two in each group, and stoma resiting in 3 patients, 70 patients after the Keyhole repair and 58 patients after the Sugarbaker repair were available for follow-up. Two of the 128 patients were lost to follow-up (Table 3). After a median observation time of 57 months following a Keyhole repair, recurrent hernia was diagnosed in 5 patients 1, 52, 57, 67, and 84 months after surgery (Table 3). In the Sugarbaker group, the median observation time was 11 months, and 6 patients presented with a recurrent hernia 6, 7, 18, 24, 30, and 65 months after repair. The recurrence rate was 10% following the Sugarbaker repair and 7% after Keyhole repair (Table 3). When the Sugarbaker repair was compared with the Keyhole repair, no statistical difference in recurrence rates was found. The recurrence rates did not differ, comparing repair of paracolostomy hernia with repair of paraileostomy hernia, patients with and without concurrent repair of an incisional hernia (Table 3), or in analyzing the size of the fascial defect.
Recurrence Rate and Late Mesh-Related Morbidity After Keyhole and Sugarbaker Repair of Parastomal Hernia in Patients Available for Follow-Up
Technical failure in a skinny patient with a left-sided ileal urinary conduit.
Recurrence of Crohn's Disease, mesh removed.
Coexisting in one of the patients with infection requiring mesh removal.
CI, 95% confidence intervals; NS, not significant, NA, not applicable.
In patients with late mesh-related morbidity, 3 of 4 patients developing mesh inflammation after Keyhole repair did not respond to conservative treatment, requiring mesh removal 8, 71, and 79 months after surgery (Table 3). One patient with recurrent Crohn's disease had the mesh removed because of small bowel obstruction 25 months after surgery. One patient experienced stoma outlet obstruction, requiring stoma relocation 14 months after Keyhole repair. In the Sugarbaker group, 3 patients with nonresponding infection had the mesh removed 11, 11, and 13 months after surgery, while 3 patients were reoperated due to small bowel obstruction caused by stenosis or adhesions related to the mesh 10, 10, and 47 months after surgery (Table 3). None of the late injuries proved fatal. Comparing patients with previous surgery for inflammatory bowel disease (IBD) to non-IBD patients, late complications occurred more frequently in patients with IBD, but it failed to reach significance (Table 3).
Discussion
Early postoperative morbidity
In the present case-controlled study, no difference in early postoperative morbidity was found between the Keyhole and the Sugarbaker technique. Interestingly, none of the patients, with inadvertent lesions of the bowel sutured before implanting the mesh, experienced early or late complications.
Recurrence
In the absence of evidence from randomized trials, methods of repair of parastomal hernia remain controversial. Published series of the two prevailing laparoscopic techniques are mostly retrospective, observational, and uncontrolled, often lacking information of studying consecutive patients. Some of the studies suffer from small sample size, have a relatively short follow-up, and vary in methods of assessment. It is reasonable to assume that recurrence rates tend to increase over time. Any given technique, therefore, should be assessed after an adequate length of follow-up. In our study, four of five recurrences after the Keyhole repair were diagnosed >4 years after laparoscopic repair. The median age of patients undergoing repair of parastomal hernia in published studies was ∼65 years. To establish a clinically relevant recurrence rate, therefore, a follow-up of at least 5 years appears reasonable. Most of the published studies report a follow-up time of <2 years.
A prospective long-term study of consecutive patients performed in our institution reported a recurrence rate of 3% after laparoscopic Keyhole repair. 12 In the present case-controlled study, the recurrence rate marginally increased to 7%. In our opinion, it is not surprising, as the follow-up was substantially longer. Compared with the Sugarbaker repair, no difference in recurrence rate was observed, even though follow-up, due to the design of our study, was markedly longer in the Keyhole group. Four of the five recurrences after Keyhole repair occurred >4 years after laparoscopic repair, substantially later than the median time of follow-up in the Sugarbaker group. Presumably, the recurrence rate after the Sugarbaker repair can be expected to increase with a longer follow-up.
While the recurrence rate after the Sugarbaker repair in our study is in keeping with published reports, the results after the Keyhole repair are inconsistent with corresponding studies. In contrast to our study, the recurrence rates after the Keyhole repair have been reported to vary from 20% to 72%.1,2,4–7,9,13,14 The Keyhole and the Sugarbaker techniques were assessed in a systematic review by Hansson et al. 10 In five studies, using an ePTFE mesh, the recurrence rate was lower in the Sugarbaker group.1,2,5,6,8 In the sixth study, the authors failed to inform what specific mesh they used for the Keyhole repair. 4 Some of these studies were retrospective, suffered from small sample size, and had a relatively short follow-up. After a well-conducted meta-analysis, it was concluded that the Sugarbaker repair, compared with Keyhole, was associated with fewer recurrences. A recent review lends support to this view. 11 In the assessment of the two methods of repair, however, Hansson et al. failed to account for the kind of mesh being used. Reading closely their article, in particular figure 6 and table 6, it is obvious that the failures following the Keyhole repair were solely associated with the use of an ePTFE mesh. 10 We suggest that a more appropriate conclusion would be that a mesh consisting of PTFE used with the Keyhole technique is inferior to a PTFE mesh used with the Sugarbaker repair.
The present case-controlled study, however, indicates that the Keyhole and the Sugarbaker repair may produce equally low recurrence rates, provided a polypropylene mesh with an antiadhesive layer is used in the Keyhole repair. Moreover, a low recurrence rate was achieved anchoring the mesh with nonabsorbable tacks without the use of transfascial sutures as recommended by Mancini et al. 3 Tacking the mesh with 1–2 cm intervals, we did not observe internal herniation between the mesh and the abdominal wall. However, rare incidents of tack-induced bowel complications have been reported. 15
In a study published shortly after the review of Hansson, Mizrahi and Parker reported a recurrence rate of 46%, using the Keyhole technique with a two-layer mesh of polypropylene and ePTFE. 13 The mesh is similar to the mesh we used in 72 of the 74 Keyhole repairs. In contrast to our mesh with a self-cut slit, aiming to accommodate the size of the bowel to fit the keyhole, they used a mesh with a predesigned manufactured opening for the stoma, either 28–35 mm or 35–45 mm in diameter. It is generally accepted that a PTFE mesh tends to shrink, resulting in an enlargement of the central opening. An enlarged opening predisposes to recurrence, as most recurrences are diagnosed along the central hole. 4 We can only speculate that the opening in the mesh used by Mizrahi and Parker was too large and that the lower recurrence rate after Keyhole in our series is due to the self-constructed keyhole in an attempt to take into account the volume of the bowel, ensuring a snug fitting of the bowel passing through the keyhole. Recent reports of uncontrolled series of the Keyhole repair or modification of the technique, using a composite polyester or polypropylene mesh, indicate that the Keyhole repair can produce satisfactory results comparable with the Sugarbaker repair.16–19
Oma et al., using various methods of parastomal hernia repair, observed a difference in the recurrence rates, comparing repair of paracolostomy hernias with repair of paraileostomy hernias. 16 In our series, we failed to find any difference either with the Keyhole or the Sugarbaker technique. Comparing large with small parastomal hernias, as defined by the European Hernia Society, Lin et al. observed no difference in recurrence rates. 20 Whether the size of a fascial defect or a concomitant repair of an incisional hernia represents risk factors of recurrence remains to be established in future studies.
Late mesh-related morbidity
Relatively few studies of parastomal hernia repair have a sufficient length of follow-up to establish the frequency of late mesh-related morbidity. According to our results, they appear to be relatively rare, but potentially life-threatening. Polypropylene or polyester meshes without any antiadhesive properties are no longer used inside the abdominal cavity. The risk of dense adhesions is substantial. Late erosion of the mesh into the bowel lumen and formation of enterocutaneous fistulas have been described.21–23 Moreover, the intraperitoneal polypropylene mesh has been reported to complicate subsequent abdominal surgery. 24 In the study of Morris-Stiff and Hughes, severe late complications were reported in 3 of 7 patients after intraperitoneal implantation of an apparently uncoated polypropylene mesh. 25 The complications occurred after a follow-up of 60, 79, and 83 months, causing small bowel obstruction due to adhesion or removal of the mesh because of intraperitoneal abscess.
In patients with previous surgery for IBD, we observed an insignificantly higher frequency of late mesh-related complication. Future studies must show whether previous surgery for IBD, especially in patients with Crohn's disease, represents a risk factor.
To reduce the risk of mesh-induced lesions, composite meshes with an antiadhesive layer to be used on the visceral side have been designed. It is achieved by coating a polypropylene or polyester mesh, delivering comparable adhesion reduction as shown in an experimental study in rats. 26 Praising the improved quality of new mesh products, the manufacturers often fail to inform about the risk and severity of late mesh-related morbidity. In the view of the seriousness of late mesh-related lesions, entailing a risk of repeat surgery, surgical societies and health authorities should consider to make demands to the manufacturers to test new meshes with respect to the clinical effect, not only with regard to potential early benefits and shortcomings, but also long-term side-effects, before launching a new mesh to the market.
Because of the poor results following nonmesh repair of parastomal hernias, however, laparoscopic mesh repair, despite the absence of evidence from randomized trials, has gained wide acceptance. Whether a late mesh-related morbidity of 8%–10%, as in our study, is acceptable and justifies continuous use of mesh in the repair of parastomal hernias remains to be solved.
Other comments
Randomized trials are preferable in identifying a superior surgical method. However, due to a relatively small difference in recurrence rates, as indicated in our study, an randomized controlled trial will require inclusion of a large number of patients, not easily achieved, even in a multi-institutional setting. Although not randomized, cohort studies derived from a nationwide database represent an alternative option. Data from a wide range of surgical departments, including patients from centers not highly specialized in hernia surgery, are collected. In an attempt to reduce the effect of selection bias, the registry should meet a criterion of at least 80% registration rate of a specific surgical procedure. 27 Data from a large number of patients with several years of follow-up are available. As a consequence, estimates of outcome will produce rather small confidence intervals, allowing for identification of possible differences between treatments or serve as a source of ideas to be tested in clinical trials. 28 Although the Danish Ventral Hernia Database does meet the criterion of covering 80% of a specific repair, such a cohort study still has limitations, as the effect of confounders and selection bias cannot be eliminated. Randomized trials are designed to achieve a high statistical power, but at the cost of including relatively few patients. Outcome derived from a nationwide database, analyzing data from a large volume of patients, however, reflects current surgical practice.
Using a polypropylene mesh with antiadhesive properties on the visceral side, our study indicates that the Keyhole and the Sugarbaker repair appear to produce equally favorable results. In patients with a wish to carry on with colostomy irrigation or in patients with a short mesentery, carrying a risk of obstruction of the lateralized bowel, the Sugarbaker technique appears to be a less suitable option. On the contrary, three factors appear to be in favor of the Sugarbaker repair. Its outcome appears to be independent of the type of mesh, whereas a mesh of sole ePTFE should not be used in the Keyhole repair. Second, the construction of the Keyhole is obviously difficult to standardize, as indicated in studies reporting unacceptedly high recurrence rates. Third, although difficult to establish scientifically, the Sugarbaker technique is perceived by some surgeons to be technically easier to perform. We are inclined to support the latter view, provided that future controlled trials with a sufficient long-term follow-up reveal recurrence rates and late mesh-related morbidity equal or superior to the Keyhole repair.
Limitations of the present study
The nonrandomized design represents a major flaw. Patients with Keyhole and Sugarbaker repair did not receive the same mesh. It represents another weakness of the study. The coated polypropylene mesh, however, was not available in the first time period, and the two-layer mesh used in the first time period was not available in the second time period. If the development of coated composite meshes actually turns out to be superior to the two-layer mesh of polypropylene and ePTFE, the patients in our study undergoing Sugarbaker repair should potentially benefit. It is, however, not reflected in our study. Having an identical median diameter of the fascial defect in the two groups, patients with a Sugarbaker repair received a slightly larger mesh (median size 15 versus 14 cm), representing another weakness of the study. The potential benefit of a marginally larger mesh was not reflected in the results.
Inclusion of consecutive patients, a prospective registration of data, and a substantial length of follow-up with 126 of 128 patients completing follow-up, however, represent a strength of the study. To our knowledge, the study represents the largest series of patients undergoing laparoscopic repair of parastomal hernia.
Conclusion
Published uncontrolled studies indicate that a mesh of sole PTFE should not be used in the Keyhole repair. Acknowledging the limitations of the present nonrandomized study, however, our study indicates that the Keyhole repair compares favorably with the Sugarbaker repair, provided a polypropylene mesh with an antiadhesive layer is used. With regard to early postoperative complications, recurrence, and late mesh-related morbidity, the Keyhole repair produces outcomes equal to the Sugarbaker technique.
Footnotes
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received.
