Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)
Conditions: Parastomal Hernia
Sponsor: Sykehuset Innlandet HF

PROJECT INFORMATION/file content: 
Study protocol 
 
Document date: June 11 2020 
 
Project title: 
LAPAROSCOPIC REPAIR OF OSTOMY HERNIA WITH MESH OUTSIDE OF THE 
ABDOMINAL CAVITY 
 
NCT number: 
NCT04440514 
 
 
 

Project description – ePauli 
 
 
1. Project title:  
Endoscopic preperitoneal parastomal hernia repair (ePauli repair)  
Short title: ePauli  
 
2. Introduction  
 
The near-invincible parastomal herniation (PSH) problem has been met with stoicism but is 
addressed more often with repair in recent years (1). Historically, low efficiency rendered 
repairs to back-against-the-wall emergency situations. Recent mesh technology and 
technique has optimized recurrence rates and adverse outcomes and a more aggressive 
attitude towards repair is exerted – both from a patient and a surgeon perspective. A local 
repair with synthetic non-absorbable mesh has better outcomes than relocation. A 
laparoscopic intraperitoneal repair (IPOM) has lower infection rate compared to open 
repair. However, the one-year recurrence rate still seems to be considerable (2-4). Key-hole 
techniques have worse outcome than the modified Sugarbaker technique: the most popular 
endoscopic procedure today with a recurrence rate around 15%. 
E. Pauli has described a modification of the Sugarbaker technique, the “Pauli repair”, 
employing a transversus abdominis release (TAR) and placement of mesh in the 
preperitoneal/pretransversalis fascia plane (5). Previous reports of TAR for incisional hernia 
involved reinforced relocation or a key-hole repair with reconstruction of the stoma (6). A 
series of open Pauli procedures have been published, with concerns about mesh 
complications and recurrence rate of 11% after median 13 months follow up (7). 
Intraperitoneal mesh increases risk of adhesion and fistula formation. In a quest for 
endoscopic repair with inherent less infection risk, but extraperitoneal mesh application to 
avoid adhesion and pain from mesh fixation, we adopted the principles of the Pauli repair to 
endoscopic surgery in a prospective series, that we termed ePauli repair. The aim was to 
assess feasibility, adverse reactions, and monitor recurrence rate. 
 
Objectives  
 
 
Feasibility, adverse reaction and effect assessment with a procedure modification. 
 
4. Project methodologies  
Patients with PSH selected for and operated with ePauli repair are enrolled in a prospective 
observational study. The study is registered as a local quality control study at Sykehuset 
Innlandet Hospital Trust with oral and written patient information and subscribed consent 
to participation and publication. The study and patient information are approved by the 
Institutional Review Board and the Data Protection Officer at Sykehuset Innlandet Hospital 
Trust. 
 

4.1 Project design, method selection and analyses  
Design  
Primary aims: feasibility of preperitoneal endoscopic repair of parastomal hernia  
Secondary aims: adverse reactions and hernia recurrence  
 
Intervention 
Laparoscopy with three ports in the opposite flank, contralateral to the stoma/PSH. Robotic 
assistance employed when available, however, in the beginning patients with concomitant 
midline hernia are selected for a laparoscopic procedure. After adhesiolysis in the 
abdominal cavity and freeing of the intestinal stoma in the hernia cavity, the rectus sheath is 
incised medially and a Rives dissection towards the semilunar line is performed. The 
parastomal hernia sack is incised in its circumference. Next step is TAR, with incision of the 
rectus sheath medial to neurovascular bundles and medial release of the fibers of the 
transversus abdominis muscle. An up-to-down approach is preferred as it is perceived easier 
to stay in the pretransversalis fascia plane and avoid making holes in the peritoneum during 
lateral development of the plane. The dissection is continued at least 10 cm lateral to the 
ostomy, and longitudinally to accommodate a 20-centimeter mesh. Previously placed 
meshes are left in situ. The posterior ostomy is moved by incision of the transversalis fascia, 
the bowel lateralized, and the fascia sutured medially. The stoma bowel is fixated to the 
flank with absorbable V-Loc and mesh is not fixated. The anterior ostomy is adapted to 
accommodate the stoma bowel with non-absorbable V-Loc placing the bowel against the 
lateral edge of the opening. A mesh, typically 18x18 centimeters in size, is placed in the 
developed pocket – in front of the posterior fascia but behind the intestine and the anterior 
abdominal wall. Mesh choice is preferably a uncoated synthetic midweight non-absorbable 
mesh with Bio-A synthetic absorbable mesh placed as barrier between the mesh and the 
bowel, laterally overlapping the non-absorbable mesh with 1 cm in order to avoid mesh 
ingrowth in the intestine. Ultimately the posterior rectus sheath is re-adapted to the linea 
alba with absorbable V-Loc. In patients with concomitant midline hernia the procedure is 
extended with an enhanced-view Rives-Stoppa (eRS) with port insertion in the ipsilateral 
flank and contralateral retromuscular dissection to the semilunar line. The linea alba is 
reconstructed with non-absorbable V-Loc and the posterior fascia/peritoneum closed with 
absorbable V-Loc. A mesh reaching from the contralateral semilunar line to the ipsilateral 
flank with stoma is placed without fixation. Drains are used selectively. 
4.2 Participants, organization and collaborations  
SI Hamar and Gjøvik. Project leader and executer is Jan Lambrecht, MD PhD. 
4.3 Budget  
No cost 
4.4 Plan for activities, visibility and dissemination  
Assemble journal data, interviews and submit publication in June 2020. 
5. User involvement  
Patient have an active role in choice of treatment and have chosen the investigated method 
with verbal informed consent. 
 
6. Ethical considerations  

The method is a modification from the “traditional” endoscopic method (Sugarbaker) with 
intraperitoneal mesh. The modification involves a component separation with medial 
release of the inner of the three lateral muscles in the abdominal wall (transversus 
abdominis) to avoid damage to motoric nerves and blood vessels to the rectus muscle and 
in order to create a pocket for extraperitoneal mesh placement. This is a very advanced 
procedure and in untrained hands possible calamities with break-down of abdominal wall 
function and structure can occur. The advantage with the procedure is that the problems 
with pain from mesh fixation and adhesion and fistula to a mesh placed intraperitoneally is 
vastly decimated. The quest to get meshes out of the abdominal cavity again, after being 
introduced for the masses with the influx of laparoscopic abdominal wall hernia repair 
around year 2000, has just begun and we increasingly use endoscopic preperitoneal 
techniques for abdominal wall hernia. We expect better outcomes regarding recurrence of 
hernia and definitively less pain and adhesion/fistula formation with the mesh outside the 
abdominal cavity as we know it from open surgery. However, we maintain the advantage of 
minimal infection risk and pain with laparo-endoscopic operations. We also have the 
experience, skill, and anatomic knowledge to perform excellently. Patients are made fully 
aware of the described modification and are actively choosing this treatment and referred 
from outside regions to receive this specific treatment. We believe it is an advancement in 
parastomal hernia repair and we are obliged to document effect and monitor adverse 
events in a quality database – as is prudent even with minor but advanced modifications to 
standard treatment. However, we do expect significant ramifications for future parastomal 
hernia treatment and focus on specialization with this evolving solution. 
 
7. References  
1. 
Gavigan, T., T. Stewart, B. Matthews, et al., Patients Undergoing Parastomal Hernia 
Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort 
Study. J Am Coll Surg, 2018. 227(4): p. 393-403 e1. 
2. 
Nasvall, P., J. Rutegard, M. Dahlberg, et al., Parastomal Hernia Repair with 
Intraperitoneal Mesh. Surg Res Pract, 2017. 2017: p. 8597463. 
3. 
Hansson, B.M., N.J. Slater, A.S. van der Velden, et al., Surgical techniques for 
parastomal hernia repair: a systematic review of the literature. Ann Surg, 2012. 
255(4): p. 685-95. 
4. 
DeAsis, F.J., B. Lapin, M.E. Gitelis, et al., Current state of laparoscopic parastomal 
hernia repair: A meta-analysis. World J Gastroenterol, 2015. 21(28): p. 8670-7. 
5. 
Pauli, E.M., R.M. Juza, and J.S. Winder, How I do it: novel parastomal herniorrhaphy 
utilizing transversus abdominis release. Hernia, 2016. 20(4): p. 547-52. 
6. 
Jones, C.M., J.S. Winder, J.D. Potochny, et al., Posterior Component Separation with 
Transversus Abdominis Release: Technique, Utility, and Outcomes in Complex 
Abdominal Wall Reconstruction. Plast Reconstr Surg, 2016. 137(2): p. 636-46. 
7. 
Tastaldi, L., I.N. Haskins, A.J. Perez, et al., Single center experience with the modified 
retromuscular Sugarbaker technique for parastomal hernia repair. Hernia, 2017. 
21(6): p. 941-949.