Hernia, VentralPhase 2BriClo2NCT04229940
Peritoneal in Laparoscopic Ventral Hernia Repair 2
A Phase 2 study testing Peritoneal bridging and No peritoneal bridging in people with Hernia, Ventral and Seroma as Procedural Complication, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Seroma as Procedural Complication
- What is being tested?
- Peritoneal bridging and No peritoneal bridging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for laparoscopic ventral hernia repair
- Defect size 3-10 cm
- BMI <40
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Peritoneal Bridging Versus no Defect Closure in Laparoscopic Ventral Hernia Repair
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.
Read the 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.
- Conditions
- Hernia, Ventral, Seroma as Procedural Complication
- Being tested
- Peritoneal bridging, No peritoneal bridging
- Keywords
- Laparoscopy,, Hernia repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal bridgingProcedure or surgery
The defect is covered by peritoneal bridging
No peritoneal bridgingProcedure or surgery
The defect is left without bridging
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal bridging | Experimental | 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 Receives: Procedure: Peritoneal bridging |
| No bridging | Active comparator | The hernia defect is left without closure prior to application of the mesh. Receives: Procedure: No peritoneal bridging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma volume
Volume of postoperative seroma measured with ultrasound
Measured: One year
Secondary outcomes (4)
Postoperative complications
Complications related to the procedure
Measured: 30 days
Postoperative pain
Pain assessed with the Ventral Hernia Pain Questionnaire for rating abdominal wall pain. Range 0-7 from no pain to most intensive pain. No subscales or added scores.
Measured: One year
Operative time
Time required to complete the procedure
Measured: 3 hours
Hernia recurrence
Recurrence of the hernia detected clinically or with computer tomography
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229940
- Sponsor's protocol ID
- BriClo2
- Acronym
- BriClo2
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali F, Sandblom G, Forgo B, Wallin G. Peritoneal Bridging Versus Nonclosure in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. Ann Surg Open. 2023 Feb 2;4(1):e257. doi: 10.1097/AS9.0000000000000257. eCollection 2023 Mar.
PubMed 37600866
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Peritoneal Bridging Versus no Defect Closure in Laparoscopic Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT04229940
- Acronym / sponsor ID
- BriClo2 / BriClo2
- Conditions
- Hernia, Ventral, Seroma as Procedural Complication
- Keywords
- Laparoscopy,, Hernia repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Peritoneal bridging | Experimental | Procedure: Peritoneal bridgingThe 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 |
| No bridging | Active comparator | Procedure: No peritoneal bridgingThe hernia defect is left without closure prior to application of the mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planned for laparoscopic ventral hernia repair
- Defect size 3-10 cm
- BMI <40
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal bridgingThe defect is covered by peritoneal bridging | Procedure or surgery | Peritoneal bridging |
| No peritoneal bridgingThe defect is left without bridging | Procedure or surgery | No bridging |
Primary outcome
Seroma volume
Time frame: One year
Volume of postoperative seroma measured with ultrasound
4 secondary outcomes
Postoperative complications
Time frame: 30 days
Postoperative pain
Time frame: One year
Operative time
Time frame: 3 hours
Hernia recurrence
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37600866Ali F, Sandblom G, Forgo B, Wallin G. Peritoneal Bridging Versus Nonclosure in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. Ann Surg Open. 2023 Feb 2;4(1):e257. doi: 10.1097/AS9.0000000000000257. eCollection 2023 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peritoneal bridging and No peritoneal bridging in people with Hernia, Ventral and Seroma as Procedural Complication, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma volume (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.