Peritoneal in Laparoscopic Ventral Hernia Repair 2
Peritoneal in Laparoscopic Ventral Hernia Repair 2
Laparoscopic ventral hernia repair (VHR) is usually performed by reducing the contents in the
 hernia sac from the abdominal cavity and then covering the defect from the inside with a
 mesh, i.e. Intraperitoneal Onlay Mesh (IPOM). This means that the hernia sac is left in situ
 anterior to the mesh. This may, however, predispose for the development of fluid in the
 hernia sac, i.e. seroma. The risk of seroma development may be reduced if a the defect is
 closed before the mesh is applied. Closing the defect may, however, cause tension and pain
 from the abdominal wall. Instead of closing the defect, the part of the peritoneum
 constituting the hernia sac may be used for closing the defect. In this case, the peritoneum
 is dissected from the edges of the hernia sac and then used as a flap that is fixated to the
 edges of the hernia sac on the opposite side. In a previous study (BriClo), we compared
 defect closure as control group with peritoneal bridging. That study showed an increased risk
 for postoperative pain if the defect was closed.

 In order to evaluate whether peritoneal bridging reduces the seroma development following
 ventral hernia repair, we are undertaking a double-blind randomized controlled trial
 comparing no closure of the defect with peritoneal bridging. The goal is to randomize 100
 patients undergoing laparoscopic ventral hernia repair.

 Clinical follow-up is performed three months, six months and one year after surgery. At all
 occasions, the patient is requested to fill in the Ventral Hernia Pain Questionnaire (VHPQ)
 and an investigation is done in order to assess the presence of seromas, recurrences or other
 local complications. Duration until return to work is registered. One year after surgery,
 computer tomography is performed in order to quantify the volume of seromas.
Background Laparoscopic ventral hernia repair (VHR) has become a well-established technique
 during the last decade. The repair is usually performed by reducing the contents in the
 hernia sac from the abdominal cavity and then covering the defect from the inside with a
 mesh, i.e. Intraperitoneal Onlay Mesh (IPOM). This means that the hernia sac is left in situ
 anterior to the mesh. This may, however, predispose for the development of fluid in the
 hernia sac, i.e. seroma. Even if the mesh prevents the intestines from protruding into the
 hernia sac, the patient may still be troubled by discomfort from the seroma that develops in
 the cavity of the previous hernia sac.

 The risk of seroma development may be reduced if a the defect is closed before the mesh is
 applied (IPOM-Plus). Closing the defect may, however, cause tension and pain from the
 abdominal wall. Instead of closing the defect, the part of the peritoneum constituting the
 hernia sac may be used for closing the defect. In this case, the peritoneum is dissected from
 the edges of the hernia sac and then used as a flap that is fixated to the edges of the
 hernia sac on the opposite side. This reduces the size of the pseudosac and the peritoneal
 surface, which prevents transudation to the pseudosac.

 In a previous study, we have compared closure of the hernia defect with peritoneal bridging.
 We found that closure of the defect increased the postoperative pain. In order to assess
 whether the potential benefit from preitoneal bridging in terms of reduced risk for seromas
 is present if the defect is not closed, we are undertaking a randomised controlled trial
 comparing bridging with IPOM without defect closure.

 In order to evaluate whether peritoneal bridging reduces the seroma development following
 ventral hernia repair, we are undertaking a randomized controlled trial. Our goal is to
 include 50 patients in the study.

 Method After obtaining written and oral consent from the patient, the randomisation is
 performed through a sealed envelope system. The patient is blinded to the allocation. Prior
 to the procedure, the patient is also requested to fill in the Ventral Hernia Pain
 Questionnaire (VHPQ).

 The procedure is started according to the usual routines. Adhesions covering the defect are
 dissected to visualize the defect. If the patients is randomized to defect closure, it is
 sutured with continuous PDS 2-0. In case the patient is allocated to peritoneal bridging, the
 peritoneum is dissected beginning 2-3 cm from the edge of the defect. The sac is dissected
 all the way to the opposite edge of the defect. The peritoneal flap is pulled to the opposite
 side and fixated with Optifix. If the patient is randomized to surgery without bridging, the
 defect is left without closure.

 The mesh is attached in the same, irrespective of randomization. Optifix with double-crown
 technique is used in both groups. Operation time and intraoperative complications are
 registered when the procedure is completed. From the day of the procedure until two days
 postoperatively, pain from the area of surgery is registered daily on a VAS-scale. Time to
 return to normal daily activities is registered.

 The patient is invited to clinical follow-up three months, six months and one year after
 surgery. At all occasions the patient is requested to fill in VHPQ. One year after surgery, a
 computer tomography while straining to detect protrusion of the abdominal contents in the
 defect. Any protrusion seen at the computer tomography is graded according to a previously
 validated classification. The presence of seromas detected at the computer tomography is
 described according to Morales-Conde, The computer tomography images are assessed by two
 radiologists in order to reach consensus. The presence of seroma anterior to the defect is
 evaluated in terms of size (maximal diameter), localization, shape (round, oval, triangular),
 mean density (Hounsfield unit, HU) and the volume through three-dimensional reconstructions.
Inclusion Criteria:

 -  Patients planned for laparoscopic ventral hernia repair

 -  Defect size 3-10 cm

 -  BMI <40

 Exclusion Criteria:

 -  Defect size >10 cm

 -  Ventral hernias with other localization than the midline

 -  Emergency surgery and incarcerated hernias

 -  Preoperative anticipation of extensive adhesions

 -  Pregnancy or intended pregnancy

 -  Serious comorbidity (ASA score >3)