Robotic Pauli repair of parastomal hernia

doi:10.21203/rs.3.rs-4486894/v2

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Robotic Pauli repair of parastomal hernia

https://doi.org/10.21203/rs.3.rs-4486894/v2

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Background

Robotic retro-muscular mesh repair of parastomal hernia (PH) is possible with transversus abdominis release. The aim of this study is to report mid-term results with this method.

Methods

Patients who underwent surgery for PH were enrolled in a prospective study. Patients with concomitant midline hernia also underwent Rives repair. Polypropylene meshes with an absorbable buffer mesh were used in the retro-muscular pocket – except PTFE was chosen for inflammatory bowel disease patients.

Results

Of the 53 included ostomy patients, 43 had colostomies, 8 had ileostomies, and 2 had urostomies, all of which were of the end type. Forty percent had a concomitant hernia, and 26% had recurrent PH. The mean operating time without accessory repair was 156 minutes (SD 37), and that with accessory repairs was 220 minutes (SD 62). Postoperative complications ensued in 12 patients (23%). One bowel lesion and one vascular injury to the stoma occurred, prompting intraoperative revision of the stoma without postoperative morbidity. One patient had late stoma necrosis and was relocated after 3 weeks. One patient had a mesh infection, 3 patients suffered temporary ileus, one patient experienced hypovolemic renal failure, and one of two patients experienced a flare-up of their IBD. One parastomal abscess was removed with a percutaneous drain. The median postoperative stay was 3 days (1–21; mean 3.7 days), and the readmission rate was 7.5%. The recurrence rate at mean and median 24 months follow up is 3.8%, both in ileostomy patients.

Conclusions

Robotic Pauli repair has shown promising results. However, repair fails of PH at small bowel ostomies with short mesentery. ePauli/TAR is now the standard operation for all eligible patients at our site.

General Surgery

Parastomal

hernia

repair

robotic

ostomy

mesh

Expansion is the natural history of hernias – also the iatrogenic hernia of an ostomy. Thus, parastomal herniation (PH) is not a conundrum but is frankly inevitable. Attempted methods for prevention have basically failed, and most repair methods have unsolicited high recurrence rates. Repair can be dangerous with extensive adhesiolysis and a risk of bowel damage, and complication rates are high.

A recent retrospective study from a national cohort in Finland reported a recurrence rate after PH repair of 24.7% (13.5% − 35.9% with various mesh techniques) and an overall complication rate of 26.4% (1). An even more recent registry-based study from a national cohort in Denmark on PH repairs reported a median hospital stay of 3.4 days, a 90-day readmission rate of 27.5%, a reoperation rate of 19.4% and a mortality rate of 1.6% for elective repairs (2). Recurrence is not stated, but the proportion of patients who underwent surgery for recurrent PH within five years was 18.8%. However, centralization has increased the number of repairs and elective patients previously rejected for complexity and comorbidity, but now-offered surgery may account for the absence of improvement in complication rate.

In 2012, a description of open-surgery lateral retro-muscular dissection, transversus abdominis release (TAR), was presented by Novitsky (3); in 2016, the application of this extraperitoneal concept to PH was described by Pauli (4), and the transformation of the TAR to endoscopic utility was described by Belyansky (5). This made it feasible to achieve endoscopic retro-muscular repair of PH after the modified Sugarbaker principle of lateralizing the intestine while protecting the ostomy with a nonslit mesh placed extraperitoneally.

The only sizeable testimony from open-surgery repair with the Pauli technique in 38 patients was disappointing, with 8% early mesh erosions into the intestine (6). The insert was a propylene mesh that was fixed with transfascial sutures that created a sharp and unforgiving edge laterally towards the redirected intestine. The cumulative complication rate was 44.7% (17/38), the 30-day readmission rate was 11%, and the reoperation rate was 8%. They reported 11% recurrence of PH after a mean follow-up of 13 months.

In designing a procedure to exploit the benefit of minimally invasive surgery but also obtain durable repair with fewer adverse effects—especially avoiding mesh position within the abdominal cavity and mesh erosion—we decided to use mesh coating over the lateral mesh edge and abstain from mesh fixation but instead secured the intestine to the abdominal wall with suture-pexy. This approach was applied to laparoscopy and subsequent robotic surgery, as has been reported by the author (7, 8). Since these reports, and apart from a few single-case reports, a small series with 11 patients has been published in which surgery was performed with approximately the same technique but using a reinforced biological mesh (9). Most patients had recurrent PH (54%). The recurrence rate was 18% after a 12-month median follow-up, the complication rate was 27%, and the median length of stay was 6 days.

The aim of the present study is to report the results from a prospective study on robotic retromuscular PH repair with the Pauli technique in an elective setting and discuss what may be improved regarding patient selection and technical considerations.

Methods

Patients with PH selected for robotic Pauli repair were enrolled in a prospective observational study. Technical ineligibility for the Pauli procedure is a previous repair that destroys dissection planes and short mesentery; the latter is predominantly a per-operative insight. The study is registered as a local quality control study at Sykehuset Innlandet Hospital Trust with oral and written patient information and consent to participate and publication. The study and patient information were approved by the Institutional Review Board and the Data Protection Officer at Sykehuset Innlandet Hospital Trust with protocol ID 137157 and registered at ClinicalTrials.gov with ID NCT04440514. The inclusion for the robotic technique opened in 2019 and is continuing at the site at Sykehuset Innlandet, Hamar surgical department. The study has not received any external support and is funded only by the surgical department. The manuscript is prepared according to the STROBE statement.

We classified hernias according to the European Herna Society taxonomy on preoperative CT scans (10). Prolapse and true parastomal herniation can both give rise to the same symptoms of pain, obstruction, and leakage. In our experience, a shortening of a prolapsed bowel with stoma revision as the only intercession leads to swift recurrence and may compromise further intervention, so we perceive any bulge as a hernia proper and have the strategy of a proper hernia operation in prolapse if the patient is suitable for this repair.

Follow-up

Follow-up is planned yearly for three years. Since our site is a referral center and most patients dwell outside the local domain, the controls were subjected to structured telephone interviews and referrals for in-house physical examination if there was suspicion of complications or re-bulging occurred at the stoma. Any postoperative complaint or off-site medical care, such as outpatient, admission or extraordinary stoma nurse care, was noted.

The likelihood of recurrence if a bulge is recorded or stoma function changes is also investigated with computed tomography (CT).

The relevant patient demographics, such as sex, body habitus, medication, cause and age of the stoma, previous repairs, prophylactic measures and concomitant hernias, were recorded. Intra- and perioperative occurrences are logged as any adverse outcomes, whereas the primary endpoint is recurrence.

Technique for robotic retro-muscular repair of parastomal hernia

Pauli repair is a technique based on the Sugarbaker principle. A retro-muscular, extraperitoneal tunnel with mesh reinforcement for lateralization of the intestinal loop was developed. Retromuscular dissection is performed behind the rectus muscle and around the stoma and continues laterally to the semilunar line with a TAR to develop the plane for the bowel to travel and place mesh between the TA muscle and the transversalis fascia. Adhesiolysis and release of the stoma loop from the hernia sack are important for generating a straight subcutaneous trajectory.

Preparation

In all patients, the abdominal wall was studied via physical examination for hernia reducibility, ostomy location and concurrent hernias. CT images were obtained to measure the ostomy size and location with respect to the distance to the linea alba and bony delimitations and to determine the hernia content, fat deposition and structural intactness of the complete abdominal wall. Prehabilitation regarding weight loss, smoking cessation, immunomodulation, exercise, and nutritional guidance is applied when appropriate. All patients received a single dose of doxycycline and metronidazole at the beginning of surgery.

Transabdominal access

Access depends on whether a concomitant midline hernia is present. Otherwise, a “trans-abdominal” approach is employed. Initial visual access is achieved with a 12-miliimeter trocar at the subcostal margin lateral to the semilunar line on the contralateral side of the parastomal hernia. After insufflation, two 8-millimeter robotic trocars were then placed on the same cranio-caudal line with a spacing of 7–8 centimeters, and the third robotic trocar was placed within the 12-millimeter port. The robotic arms of the Intuitive Xi or X robotic systems are docked after any necessary adhesiolysis at the trocar sites. Then, adhesiolysis of the stoma bowel and reduction of the hernia content are performed, which can be a demanding ordeal regardless of the chosen repair method.

If the ostomy lies more than 5 cm from the linea alba, the entry from the abdominal cavity into the retromuscular plane is through the peritoneum and the posterior rectus sheath adjacent to the linea alba on the ipsilateral side of the stoma. If the ostomy is closer than 5 cm to the linea alba, the beginning of extraperitoneal dissection starts at the contralateral side of the stoma to allow a mesh to cross the midline with sufficient medial overlap from the defect and be covered by the peritoneum under and at the contralateral side of the midline from the stoma. Another possibility is entrance into the contralateral retro-muscular space and then preperitoneal dissection across the midline if the preperitoneal fat is sparse or the peritoneum is delicate or absent.

The retromuscular plane in the rectus sheath is then developed around the stoma and 10 cm cranially and caudally towards the semilunar line but is stopped when the neurovascular bundles supplying the rectus muscle are met.

Direct retromuscular access (eTEP)

In patients with concomitant midline defects or contralateral defects, complete extraperitoneal access is chosen, employing direct visual entrance to the contralateral retrorectus space with a 12 mm optical trocar slightly more medially than with the transabdominal approach and performing endoscopic Rives’ (eR) dissection with midline crossover behind the linea alba without entering the abdominal cavity, if possible, although this often occurs in the midline with incisional hernias. The parastomal hernia sac was opened from the retrorectus plane, hernia reduction and any necessary adhesiolysis were performed, and the plane was developed laterally.

TAR

With both approaches, a TAR is then performed. Since the ostomy most often is placed at the lateral edge of the rectus sheath, it is necessary to employ both top-down and bottom-up TAR to advance toward the ostomy from both sides. The peritoneum is thin in the upper part of the abdomen, and a top-down approach will more easily preserve the supportive transversalis fascia. We aim to preserve this plane somewhat caudally to the stoma before fusing with the preperitoneal plane via bottom-up dissection. When the posterior fascia is later closed after the stoma is lateralized, the peritoneum alone, without the support of the transversalis fascia, is too fragile for suture purchase. Lateral dissection in the TAR plane was continued at least 10 cm lateral to the hernia defect.

Intestinal rerouting

After the development of the TAR plane and a landing zone for a mesh, preferably not less than 18 cm in cranio-caudal length, the posterior retro-muscular fascia is incised lateral to the stoma all the way to the edge of the developed TAR plane. Next, the stoma is repositioned by internal traction and external manipulation in anticipation of a posthernia position and trajectory to have a bowel course through the abdominal wall and the mesh conduit without folds. However, too much traction can retract the stoma, and this assessment is delicate; some folding of the intestine is preferable to retraction and stoma appliance difficulties. After proper traction is achieved, the bowel is fixed to the anterior abdominal wall with a 23 cm long 2 − 0 absorbable barbed running suture, and the mesentery is grasped with care not to violate the vascular supply, from lateral to medial for 6–7 cm at the cranial side and on the caudal side, with superficial bites into the mesentery and transversus abdominis muscle. Suturing the bowel to the abdominal wall prevents dislocation of the bowel, and mesh fixation is superfluous in most cases. In the beginning of this series, running fixation occurred on only one side, but in all instances, the lateral point of the rerouted intestine was fixated to the lateral abdominal wall on both sides.

Suturing layers

Care must be taken not to strangulate the bowel with a too-tight internal opening to the peritoneal cavity, but a firm closure must still be obtained when transposing the inner opening by a running 2 − 0 absorbable barbed suture from lateral to medial. The bowel is thus secured, and a retromuscular tunnel is created with lateralization of the inner ostomy. The aim is a distance of at least 8 cm from the lateral edge of the outer ostomy to the transposed inner aperture. The outer ostomy with the hernia defect is then partially closed and adapted to the passing bowel. The direction of adaptation must be tailored, but since the bowel is affixed towards the firm lateral border and typically in a slight cranial direction from the outer ostomy, a medial-caudal absorbable 0–0 double-layer barbed suture is appropriate.

Mesh application

A ruler was then used to gauge the space for mesh placement. The size of the mesh should reach 18 cm x 18 cm, and if dissection has not been lateral, caudal, or cranial enough, the space will not accommodate this mesh size. The mesh used should be large-pore, synthetic and nonabsorbable polypropylene or polyester material. However, concerns of mesh ingrowth into the intestine and mesentery with late complications, such as devascularization, infection and fistula formation, may warrant a protective cushion between the nonabsorbable mesh and the bowel, especially at the edge of the mesh. In high-risk patients with fistulas, such as those with Crohn’s disease, the risk is increased, and the use of absorbable fibrin-scaffolding barrier mesh or possibly a large-pore PTFE material could be favourable. In this series, a polypropylene mesh (Optilene or Progrip) with a second cushion mesh made of synthetic absorbable material (Bio-A) was applied in all patients without inflammatory bowel disease (IBD), whereas a semicoated perforated PTFE mesh (Synecor) was utilized in IBD patients. The cushion mesh was at the very beginning sutured to the nonabsorbable mesh intraabdominally, but we found a way to usher in the tightly rolled meshes by uncapping the 12-mm trocar and using gel in the trocar cylinder to facilitate mesh introduction.

The mesh is fashioned to exceed lateral overlap past the bowel with indentation around the bowel to maximize the lateral mesh surface for ingrowth. Most often, the mesh placement is secure from migration without fixation, but the mesh can be suture-anchored to the anterior abdominal wall if it is difficult to maintain its position before deflation. The envisioned advantages of bowel fixation and no mesh fixation are that the bowel is secured against migration during healing and that the mesh can adapt to the bowel, conceivably reducing the risk of bowel strangulation at the mesh edge.

In the transabdominal approach without concomitant hernia, the retromuscular pocket is closed after mesh placement by suturing the posterior fascia/peritoneum to the linea alba. If a midline or other hernia is repaired with direct retro-muscular entry with eR repair or contralateral TAR, the needed retro-muscular dissection is performed, and the defects are sutured with 0–0 absorbable barbed suture and a mesh is tailored appropriately—mostly as a one-piece mesh or, if necessary, by overlapping the stoma mesh. Any defects in the posterior layer were closed with absorbable sutures. Drains were not used in this series.

Postoperative care

Patients are asked to avoid heavy lifting and use stoma belts day and night for the first month, then during the daytime the next month and subsequently when they are physically active. They are advised on lifting techniques and gentle training of the abdominal wall (Pilates).

Statistics

Descriptive statistics only.

Overall, 53 patients were included, 24 of whom were females (45%). None of the patients were lost to follow-up. The mean age at operation was 63 years (SD 10.4, min–max 39–87). The mean BMI was 28 (SD 4.8), and the median age of the stoma was 40 months (13–338). All patients had end ostomies, of whom 43 had colostomies (81%), and 8 had ileostomies and 2 had urostomies. The predominant reason for a stoma was rectal cancer operation in 43 patients (49%), followed by 7 (13%) with Crohn’s disease, 5 with anal incontinence, 3 of both ulcerative colitis and Cauda Equina syndrome, 2 with constipation, diverticulosis, and anal fistula, and one of each with bladder cancer, cystitis and mesenteric hyperganglionosis. Prophylactic mesh was applied to 4 (7.5%) patients at ostomy formation, 14 (26.4%) patients had recurrent PH, and 5 patients had multiple repairs. PH was classified as Type I in 14 patients, Type II in 8 patients, Type III in 18 patients and Type IV in 13 patients. The mean ostomy aperture size measured in the largest of the axial, sagittal or frontal CT projections was 53.7 millimeters (SD 14.3). Patient characteristics are shown in Table 1.

The mean operating time was 186 minutes from skin to skin (SD 59). Without accessory repair (n = 32: only PH repair via the transabdominal approach), the operation lasted a mean of 156 minutes (SD 37), and with accessory repairs, the mean operating time was 220 minutes (SD 62). One serosa lesion arose during the operation, and one devascularisation of the stoma occurred, prompting intraoperative revision of the stoma without postoperative morbidity; additionally, 3 patients underwent planned stoma revision. The remaining accessory repairs were concomitant hernias treated simultaneously with PH (n = 21, 39.6%). and predominantly operated with the direct extraperitoneal eTEP approach (n = 19, exemplary video enclosed).

Postoperative complications occurred in 12 patients (23%). One patient had stoma necrosis and subcutaneous infection around the stoma bowel, which occurred three weeks after the hernia repair. The stoma was relocated. One multimorbid patient had a mesh infection, and the PTFE mesh was changed to a Bio-A mesh by laparoscopy. Two patients suffered temporary ileus, one patient acquired hypovolemic renal failure, and one of two patients experienced severe Crohn’s disease resembling postoperative infection, which manifested as a mesh reaction. The patient with renal failure initially had ileus but was dismissed and later returned with high output. Diagnostic laparoscopy was performed, and very inflammatory repair was observed, but no puss or bacterial growth was exposed. After a while on antibacterial therapy, we decided to abandon this therapy and treat the patient with a short course of systemic steroids, which healed the patient. When a similar inflammatory situation occurred in another patient with a negative CT scan, we also administered antibacterial therapy, but vials and procalcitonin tests were negative, and we were quicker to start successful steroid treatment and shorten the period of morbidity. Among the four patients who required reoperation, no pathology was found in one patient with Crohn’s disease who underwent laparoscopy for postoperative pain. The reoperation rate was 7.6%. Other complications included one parastomal abscess, which resolved with percutaneous drainage and antibiotics. Three patients had delayed stool passage, and two of them underwent endoscopy without pathology. One patient had an untreated flank hematoma, one had pulmonary edema from atrial fibrillation, and two had untreated seromas. The median postoperative stay was 3 days (1–21; mean 3.7 days, SD 3.4), and 4 (7.5%) patients were readmitted to the hospital. The recurrence rate at mean and median 24-months follow-up (SD 16.7, min–max 1–53) were 3.8% (2/53). The recurrences were both in ileostomy patients, one from rectal cancer treatment and one from Crohn’s disease. The results are shown in Table 2.

The closest study to compare with methodologywise is the smaller Dutch study where a similar robotic technique is used, albeit with a different mesh compound (9). The 18% recurrence rate after a median of 12 months of follow-up in this study hinges on only two patients. However, 38 patients exceeded the 1-year control in our study, and the same number of recurrences and a much smaller proportion of recurrences were noted. The numbers in the Dutch study are small, and the results are not inferable.

The complication and recurrence rates in our study seem favourable compared to those of the open variant of Pauli repair (6), with half the registered complications and a lower recurrence rate after double follow-up time. However, patient variables are not equal, with a higher morbidity load and a higher fraction of ileostomies in this study, so direct comparison is difficult. Transfascial suture may have seriously impacted the complication rate in the study by Tastaldi et al., which greatly influenced our strategy of not suturing the mesh. We did not observe mesh problems except for the cases of alleged mesh derivative activation of the inflammatory response in patients with Crohn’s disease. Nevertheless, with this comparison, we seem to have managed improvement and avoided mesh-related failures. The cushioning over the mesh edge does add to the price of the repair, and in the centers where I am aware the method is utilised, no one has adopted cushioning and use an uncoated polypropylene mesh. This methodology was not tested in the present study, but the outcomes of studies from those centres are awaited. In colostomies, this is likely not hazardous since the colopexy tucks the bowels serosal surface away from the mesh. However, nonfixation of the mesh is likely crucial.

The complication rates also seem to be on par with or lower than those in studies involving alternative operative strategies. Compared with the Finnish retrospective results, we observe similar complication rates but a much lower recurrence rate; however, the median follow-up was only 24 months, while the rate in the Finnish study was 39 months (1). Compared to the Danish registry study, we observed lower readmission, morbidity, and mortality rates (zero). Moreover, although comparison of recurrence is not directly possible since this was not recorded in the Danish study, the rerepair rate after a median follow-up of 27 months was almost the quintuple of the recurrence rate we observed in our study with an equivalent observation period and matching demographics (2). The rerepair rates can be compared and were 11 times greater in the Danish study.

The most aggravating deficiency with our study design is the phone-based follow-up. The patients are from all over in the geographically large country of Norway, and many patients would need a flight or a road trip with accommodation for a short physical examination. We could not put that load on the patients, and we have no means to finance such logistics. However, the public health system is congruent in Norway, communication is good, and patients can receive help locally with any complications and CT scans for investigation, evaluation, and referral. If requested, the patients have free access to our facility. Additionally, we did not investigate patient-reported outcomes, which will be essential in upcoming studies.

Dissection in the parastomal sack can be perilous, and in certain cases, the dissection is stopped before full release for safety reasons. In these cases, a hybrid approach with open adhesiolysis and stoma reconstruction can be considered, but it may carry an increased risk of infection. We did not do this routinely, but rather did so in five patients. Three decisions were made intraoperatively: one where we had damage to the small bowel at the skin level, one with devascularization during dissection and one because of stenosis from a previous mesh. We do not use Firefly fluorescence in all cases, but after experiencing delayed necrosis, it is part of our assessment if we suspect that the stoma is in peril regarding blood supply. It was aiding us in the decision to reconstruct the stoma in the one case it happened for this reason and might have saved this patient from gruesome adversity. Two revisions were planned: one because the stoma opening was so great that the stoma appliance would not fit, and one had fistulae at the stoma. No infection, however, occurred in those patients, so the risk did not seem notable. Stopping dissection before full release may cause some remaining subcutaneous bowel in a small loop. Additionally, insufficient retraction when performing entero-pexy may cause the same, but to gauge the correct retraction in the inflated cavity without inversion of the stoma is very testing. We decided not to take improper risks and avoid retraction of the stoma, and later, if necessary, perform an open stoma revision. During the follow-up of patients with regular CT scans, we noted a tendency toward an increase in the volume of the subcutaneous bowel—a prolapsing inclination—but no patients presented it as a problem, and no revisions were made.

The two recurrences that occurred were both ileostomies. The first recurrence was noted at 2 years of follow-up. The mesh insert had migrated medially, pushed by the mesentery, and no longer protected the ostomy. After this, we were careful not to lateralise the small bowel with resistance and thus omitted Pauli repair. Instead, we chose a chimney mesh – either intraperitoneally or in the retro-muscular space with the chimney penetrating the posterior layer along with the intestine. These patients were not included in this report. The first recurrence was repaired with intraperitoneal chimney mesh, but unfortunately, it recurred, and the patient requests additional repair. Despite being aware of the problem, the same situation occurred with the 2nd recurrence, which recurred 4 months after the primary repair. We probably still pushed the limit with forceful lateralization of an ileostomy and aim to avoid this happening in the future. Chimney mesh repair may not be the most efficient repair of recurrence after Pauli repair, and if forced to revert to intraperitoneal repair, a sandwich construction could be considered even though this approach also involves bowel lateralization, but the options are limited.

Robotic Pauli repair is challenging but shows promising mid-term results regarding the repair of parastomal herniation in end-colostomies. However, repair of PH at small bowel stomas with short mesentery fails and other strategies both in planning and per operatively must be within reach. Nevertheless, surgery via the ePauli/TAR methodology is now the standard operation for all eligible patients with PH at our site.

Disclosures

Dr. Jan Roland Lambrecht discloses having received speaker fees from Dansac-Holister, Coloplast, Medtronic and Intuitive; having received advisory fees from Medtronic and Intuitive; and having an agreement with Intuitive for case observations and proctoring, and as course leader in robotic hernia training.

Funding:

No funding

Makarainen-Uhlback E, Vironen J, Falenius V, Nordstrom P, Valikoski A, Kossi J et al (2021) Parastomal Hernia: A Retrospective Nationwide Cohort Study Comparing Different Techniques with Long-Term Follow-Up. World J Surg 45(6):1742–1749. 10.1007/s00268-021-05990-z
Helgstrand F, Henriksen NA (2022) Outcomes of parastomal hernia repair after national centralization. Br J Surg 110(1):60–66. 10.1093/bjs/znac320
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The authors declare potential competing interests as follows: Author declares a proctor, case observation and advisory contract with Intuitive.

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Totally extraperotoneal repair of midline incisional and parastomal hernias with robotic Rives' and Pauli repair
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Robotic Pauli repair of parastomal hernia

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Version 2

Abstract

Background

Methods

Results

Conclusions

Introduction

Inclusion

Definition of PH

Follow-up

Study parameters

Technique for robotic retro-muscular repair of parastomal hernia

Preparation

Transabdominal access

Direct retromuscular access (eTEP)

TAR

Intestinal rerouting

Suturing layers

Mesh application

Postoperative care

Statistics

Results

Discussion

Conclusion

Declarations

Disclosures

Funding:

References

Additional Declarations

Supplementary Files

Status:

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