Can mesh placement prevent port site hernia after sleeve gastrectomy?
| ISRCTN | ISRCTN52462725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52462725 |
| Secondary identifying numbers | PISM cohort study |
- Submission date
- 26/11/2019
- Registration date
- 02/01/2020
- Last edited
- 13/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
| Phone | +33 (0)1 45 37 43 47 |
|---|---|
| martin.gaillard@aphp.fr |
Scientific
Department of minimally invasive digestive surgery
Hôpital Antoine Béclère
157 rue de la porte de trivaux
Clamart
92140
France
| Phone | +33 (0)1 45 37 43 47 |
|---|---|
| hadrien.tranchart@aphp.fr |
Study information
| Study design | Single-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prevention of incisional hernia using prophylactic permanent or absorbable mesh following single-port laparoscopic sleeve gastrectomy: a cohort study |
| Study acronym | PRISM |
| Study objectives | Absorbable mesh is effective for hernia prevention following single-port laparoscopic sleeve gastrectomy |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2019 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 255 |
| Key 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 |
| Key exclusion criteria | 1. Previous upper abdominal surgery (cholecystectomy excepted) 2. Patient under guardianship and trusteeship 3. Patient with known allergy to mesh components |
| Date of first enrolment | 01/01/2020 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- France
Study participating centre
157 rue de la porte de trivaux
Clamart
92140
France
Sponsor information
Hospital/treatment centre
Department of minimally invasive digestive surgery
157 rue de la porte de trivaux
Clamart
92140
France
| Phone | +33 (0)1 45 37 43 47 |
|---|---|
| hadrien.tranchart@aphp.fr | |
| Website | http://www.aphp.fr/contenu/hopital-antoine-beclere-1 |
"ROR" |
https://ror.org/04sb8a726 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Assistance Publique Hôpitaux de Paris, Assistance Publique–Hôpitaux de Paris, AP-HP
- Location
- France
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/02/2022 | 13/07/2022 | Yes | No |
Editorial Notes
13/07/2022: Recruitment to this study is no longer paused. The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/02/2020: Internal review.
13/12/2019: Trial's existence confirmed by Assistance Publique-Hôpitaux de Paris.
