Randomised Controlled Trial of Peritoneal Bridging Versus no Defect Closure in Laparoscopic Ventral Hernia Repair
Peritoneal in Laparoscopic Ventral Hernia Repair 2
Sponsors
Source
Karolinska Institutet
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
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.
Detailed Description
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.
Overall Status
Completed
Start Date
2019-03-01
Completion Date
2021-12-31
Primary Completion Date
2020-12-31
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Seroma volume |
One year |
Secondary Outcome
Measure |
Time Frame |
|
Postoperative complications |
30 days |
|
Postoperative pain |
One year |
|
Operative time |
3 hours |
|
Hernia recurrence |
One year |
Enrollment
115
Conditions
Intervention
Intervention Type
Procedure
Intervention Name
Description
The defect is covered by peritoneal bridging
Arm Group Label
Peritoneal bridging
Intervention Type
Procedure
Intervention Name
Description
The defect is left without bridging
Arm Group Label
No bridging
Eligibility
Criteria
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)
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Location
Facility |
|
Department of Surgery, Karloskoga Hospital Karlskoga 2701715 69144 Sweden |
Location Countries
Country
Sweden
Verification Date
2022-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Karolinska Institutet
Investigator Full Name
Gabriel Sandblom
Investigator Title
Associate Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Peritoneal bridging
Arm Group Type
Experimental
Description
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
Arm Group Label
No bridging
Arm Group Type
Active Comparator
Description
The hernia defect is left without closure prior to application of the mesh.
Firstreceived Results Date
N/A
Acronym
BriClo2
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind randomized controlled trial.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
The patient undergoing surgery and the physician performing the follow-up are masked to
the allocation.
Study First Submitted
January 13, 2020
Study First Submitted Qc
January 14, 2020
Study First Posted
January 18, 2020
Last Update Submitted
March 30, 2022
Last Update Submitted Qc
March 30, 2022
Last Update Posted
March 31, 2022
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.