Plain English Summary
Background and study aims
Obesity has become the new pandemic, and since the introduction of surgical treatment, bariatric procedures have become one of the most popular types of surgery, with 60,000 procedures performed in France in 2016. Efforts are being made to reduce surgical morbidities, and among them trocar-site hernias. Indeed, data from non-bariatric population define obesity as a major risk factor for developing trocar site hernias. A recent systematic review reported a 24.5% rate of trocar-site hernias after laparoscopic bariatric surgery. In order to prevent reduce the incidence of trocar-site hernia after single-port laparoscopic sleeve gastrectomy, surgeons have been placing prophylactic mesh at the time of the abdominal closure. Reinforcement with either permanent or absorbable synthetic mesh has been performed but the type of material that should be preferred has not been determined. Because of concern regarding long-term mesh complications from prophylactic permanent synthetic mesh, there is interest in absorbable mesh, but there is no convincing evidence that the latter are effective for hernia prevention. The aim of this study is to assess the outcomes of the routine placement of prophylactic permanent or absorbable mesh in preventing the development of trocar-site hernia without increased risk of incisional site complications.
Who can participate?
Adult patients with body mass index > 45 kg/m² undergoing laparoscopic single-port sleeve gastrectomy as a primary bariatric procedure
What does the study involve?
As participants undergoing sleeve gastrectomy (regardless of mesh placement) sign up for a scheduled postoperative follow-up, no additional outpatient visit or examination is required in this study.
What are the possible benefits and risks of participating?
Placement of prophylactic mesh is routine care. Possible benefits related to the use of permanent mesh is a reduction of incisional hernia rate with the risk of increased wound infection rate. Compared with permanent mesh, the use of absorbable mesh is possibly less effective in the reduction of incisional hernia rate without increasing the risk of wound infection.
Where is the study run from?
Antoine Beclere Hospital of Assistance Publique-Hôpitaux de Paris (France)
When is the study starting and how long is it expected to run for?
December 2019 to December 2021
Who is funding the study?
Assistance Publique-Hôpitaux de Paris (France)
Who is the main contact?
Dr Hadrien Tranchart
hadrien.tranchart@aphp.fr
Trial website
Contact information
Type
Public
Primary contact
Dr Martin Gaillard
ORCID ID
Contact details
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
+33 (0)1 45 37 43 47
martin.gaillard@aphp.fr
Type
Scientific
Additional contact
Dr Hadrien Tranchart
ORCID ID
Contact details
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
+33 (0)1 45 37 43 47
hadrien.tranchart@aphp.fr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
PISM cohort study
Study information
Scientific title
Prevention of incisional hernia using prophylactic permanent or absorbable mesh following single-port laparoscopic sleeve gastrectomy: a cohort study
Acronym
PRISM
Study hypothesis
Obesity has become the new pandemic, and since the introduction of surgical treatment, bariatric procedures have become one of the most popular types of surgery, with 60.000 procedures performed in France in 2016. Efforts are being made to reduce surgical morbidities, and among them trocart-site hernias. Indeed, data from non-bariatric population define obesity as a major risk factor for developing trocar site hernias. A recent systematic review reported a 24.5% rate of trocar-site hernias after bariatric laparoscopic surgery.
In order to prevent reduce the incidence of trocar-site hernia after single-port laparoscopic sleeve gastrectomy, surgeons in our department have been placing prophylactic mesh at the time of the abdominal closure. Reinforcement with either permanent or absorbable synthetic mesh have been performed but the type of material that should be preferred has not been determined. Because of concern regarding long-term mesh complications from prophylactic permanent synthetic mesh, there is interest in absorbable mesh, however, there is no convincing evidence that the latter are effective for hernia prevention.
Ethics approval
No ethics approval is required for this study, since it is an observational cohort of a routine procedure. This was validated with the clinical research unit of the Paris-Sud University.
Study design
Single-centre observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Trocar-site hernia in obese patients undergoing bariatric surgery
Intervention
All consecutive adults patients with body mass index > 45 kg/m² undergoing laparoscopic single-port sleeve gastrectomy as a primary bariatric procedure will be included during a one-year period with a one-year follow-up.
Placement of a prophylactic synthetic mesh is performed routinely at the time of the abdominal closure after single-port laparoscopic sleeve gastrectomy, either with permanent or absorbable synthetic mesh, at the surgeon's discretion.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Occurrence of trocar-site hernia during the first postoperative year observed:
1.1. On CT scan investigating suspicion of trocar-site hernia at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure
1.2. On routine systematic CT scan performed at 1 year of the surgical procedure
Secondary outcome measures
1. Occurrence of complications related to the prophylactic mesh during the first postoperative year:
1.1. Incisional site infection at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure
1.2. Abdominal pain requiring grade III analgesics at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure
Overall trial start date
01/12/2019
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Consecutive patients undergoing single-port laparoscopic with prophylactic mesh placement
2. Decision for intervention after multidisciplinary discussion
3. Sleeve gastrectomy as a primary bariatric procedure
4. Body mass index > 45 kg/m²
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Previous upper abdominal surgery (cholecystectomy excepted)
2. Patient under guardianship and trusteeship
3. Patient with known allergy to mesh components
Recruitment start date
01/01/2020
Recruitment end date
31/12/2020
Locations
Countries of recruitment
France
Trial participating centre
Hôpital Antoine Béclère
Department of minimally invasive digestive surgery
157 rue de la porte de trivaux
Clamart
92140
France
Sponsor information
Organisation
Hôpital Antoine Béclère
Sponsor details
Department of minimally invasive digestive surgery
157 rue de la porte de trivaux
Clamart
92140
France
+33 (0)1 45 37 43 47
hadrien.tranchart@aphp.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Assistance Publique - Hôpitaux de Paris
Alternative name(s)
Assistance Publique Hôpitaux de Paris, AP-HP
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
France
Results and Publications
Publication and dissemination plan
Protocol is not published or available online and no publication of this document is planned. Data analysis will take place in the first months of 2021 and publication will be submitted near the end of 2021.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/10/2021
Participant level data
Other
Basic results (scientific)
Publication list