Condition category
Surgery
Date applied
26/11/2019
Date assigned
02/01/2020
Last edited
02/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

13/12/2019: Trial's existence confirmed by Assistance Publique-Hôpitaux de Paris.