Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04510558 |
| Other study ID # |
PROMESH TRIAL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University Hospital, Geneva |
| Contact |
Jeremy Meyer, MD, MD-PhD |
| Phone |
+41795533182 |
| Email |
jeremy.meyer[@]unige.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background:
Preliminary studies have shown that application of a prophylactic mesh during stoma closure
reduces the incidence of incisional hernia at site of stoma closure.
Methods/Design:
The study will be a randomized controlled single-blinded monocentric study determining the
1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy
closure with or without prophylactic non-absorbable mesh applied in the sublay position.
Discussion:
Prevention of incisional hernia at site of stoma closure will lead to an improvement in
patients' quality of life and generating savings for healthcare systems. To date, no
randomized controlled trial assessing the effect of prophylactic mesh applied during stoma
closure on the prevention of incisional hernia has been published. With the present
randomized controlled trial, we expect to demonstrate that the application of a prophylactic
mesh reduces the one-year incidence of incisional hernia at site of stoma closure.
Description:
Background:
Recent pooled evidence indicates that the incidence of incisional hernia after stoma closure
is of 7.4%, but this finding is limited by an important heterogeneity (reported incidences
ranging from 0 to 48%). The pooled incidence of incisional hernia ranges from 4 to 10%
according to the type of stoma, with the highest incidence reported after colostomy closure
(10%). These incisional hernias at site of stoma generate patient discomfort, alteration of
quality of life, complications such as bowel occlusion and increased costs for healthcare
systems.
Several retrospective studies have investigated the impact of a prophylactic mesh during
stoma closure on the incidence of incisional hernia. For instance, Liu et al. compared 47
patients who benefited from ileostomy closure with a synthetic non-resorbable mesh with 36
patients who underwent the same surgery without mesh, and found that incidences of incisional
hernia (with a median follow-up of 18 months) were of 6.4% and 36.1%, respectively 3.
Similarly, a retrospective case-control study compared 30 patients who had ileostomy closure
with prophylactic biological mesh with 30 matched patients without mesh. At one year, the
incidence of incisional hernia diagnosed with CTscan was of 3.3% in patients with mesh versus
40% in patients without mesh 4. A multicenter randomized controlled trial (RCT) is currently
underway to evaluate whether an intra-abdominal mesh allows to prevent the one year incidence
of CTscan-proven incisional hernia in patients undergoing ileostomy and colostomy closures 5.
A preliminary feasibility study demonstrated the safety of the procedure 6. However, no
specific techniques for mesh fixation and position are documented in the RCT protocol, which
might introduce confusion factors in the final analysis. Further, applying an intra-abdominal
mesh might potentially result in long-term complications due to bowel adhesion to the
abdominal wall.
Therefore, we have planned to undertake a RCT aiming at determining whether a prophylactic
non-resorbable mesh in the sublay position allows or not reducing the incidence of incisional
hernia after ileostomy or colostomy closure.
Methods/Design:
Study design:
The study will be a randomized controlled single-blinded monocentric study determining the
one year incidence of incisional hernia in patients undergoing ileostomy or colostomy closure
with or without prophylactic mesh.
Study setting:
The study will take place at the Division of Digestive Surgery, University Hospitals of
Geneva, Geneva, Switzerland.
Population:
Adult patients undergoing ileostomy or colostomy closure after surgery for digestive cancer
will be considered as eligible for the study.
Inclusion criteria:
- Adult patient
- Ileostomy or colostomy performed during surgery for digestive cancer
- Planned elective closure of ileostomy or colostomy
- Informed written consent
Exclusion criteria:
- Allergy to mesh
- Patients under corticosteroids or other immunosuppressive treatment
- Inability/refusal to follow the procedures of the study
Drop-outs:
- Stoma closure not performed
- One-year follow-up not completed
- Withdrawal of consent
- Redo surgery at the site of stoma not related to the mesh and/or to incisional hernia
- Violation of protocol
Intervention: Stoma closure with non-resorbable mesh in the sublay position
- Antibioprophylaxis using cefuroxime and metronidazole
- Standard disinfection and sterile draping
- Circular incision around the stoma using the scalpel blade
- Dissection around the stoma until entering the abdominal cavity
- Closure of the stoma using a linear stapler
- A midline laparotomy may be performed or not
- Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis
- Closure of the posterior aponeurosis using separate Maxon 2-0 stitches
- Application of an ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson, with +2cm on the
edges, secured by 4 stiches of Maxon 2-0
- Closure of the anterior aponeurosis using separate Maxon 2-0 stitches
- No subcutaneous stitches
- Partial purse string skin closure using Monocryl 3-0
- Standard wound dressing
Control: Stoma closure without mesh
- Antibioprophylaxis using cefuroxime and metronidazole
- Standard disinfection and sterile draping
- Circular incision around the stoma using the scalpel blade
- Dissection around the stoma until entering the abdominal cavity
- Closure of the stoma using a linear stapler
- A midline laparotomy may be performed or not
- Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis
- Closure of the posterior aponeurosis using separate Maxon 2-0 stitches
- Closure of the anterior aponeurosis using separate Maxon 2-0 stitches
- No subcutaneous stitches
- Partial purse string skin closure using Monocryl 3-0
- Standard wound dressing
Outcomes:
Primary outcome:
The primary outcome will be the incidence of incisional hernia at site of stoma at one year
after closure. The presence or not of an incisional hernia will be assessed clinically by a
specialist in general surgery and radiologically by computed tomography realized in the
setting of cancer follow-up. The investigator performing the one-year follow-up and the
radiologist interpreting the CTscan will be blinded for the study group. Patients diagnosed
with incisional hernia and/or reoperated for a complication related to stoma closure and/or
mesh will be considered as treatment failure.
Secondary outcome:
The secondary outcome will be the incidence of surgical site infection (SSI) at site of stoma
closure, evaluated at 7 and at 31 days after stoma closure according to the Center for
Disease Control definition. Specialized nurses will record pictures of the stoma site for
blinded evaluation by an investigator. In case of occurrence, SSI will be treated according
to institutional guidelines.
Randomization, allocation concealment and blinding :
Patients will be recruited during the preoperative consultation. Patients will be given
written information related to the study and will sign an informed consent form.
Investigators will be contacted and perform randomization using the RedCap (Research
Electronic Data Capture) software system on a 1:1 allocation ratio between study groups. The
surgery planning form will be forwarded to the investigators, which will indicate if a mesh
should be added or not to the stoma closure procedure. Patients will be blinded for the study
group.
Sample size calculation:
Considering the results of existing studies comparing the incidence of incisional hernia
after stoma closure with and without prophylactic mesh, we aimed reducing the incidence of
incisional hernia from 30% to 5%. Using the two-sided Pearson's chi-squared test for
proportions, with a power set at 0.8 and an alpha at 0.05, and considering a 1:1 allocation
ratio, we will have to include 72 patients (36 with mesh and 36 without mesh).
Variables of interest:
Variables of interest will be recorded by the investigator into a case-report form generated
in the RedCap software.
Variables related to stoma confection:
- Date of stoma confection
- Age
- Gender
- BMI
- ASA class
- Tobacco use
- Pre-albumin concentration
- Albumin concentration
- Proteins concentration
- Neo-adjuvant treatment
- Surgery performed in emergency or elective setting
- Diagnostic
- Type of surgery performed
- Type of stoma
- Site of stoma
- Length of stay
Variables related to stoma closure:
- Date of stoma closure
- Age
- BMI
- ASA class
- Tobacco use
- Pre-albumin concentration
- Albumin concentration
- Proteins concentration
- Type of surgery performed
- Presence or not of a parastomal hernia
- Length of stay
Variables related to follow-up at 7 days after the stoma closure:
- Date of early follow-up
- Presence or not of a SSI
- Pictures of the stoma site
Variables related to follow-up at 1 year after stoma closure:
- Date of late follow-up
- Age
- BMI
- Adjuvant treatment
- Presence or not of an incisional hernia at the site of stoma closure (clinical
examination)
- Presence or not of an incisional hernia at the site of stoma closure (CTscan)
- If appropriate, variables related to the management of the incisional hernia
Statistical analysis :
Continuous variables will be expressed as medians±SD. Categorical variables will be expressed
as numbers (proportions). Continuous variables and outcomes will be compared using the
two-sided Student's t test. Categorical variables and outcomes will be compared using the
Chi-square test or the exact Fisher test, when appropriate. Subgroup analyses will be
performed according to BMI class and type of stoma. An in interim analysis will be performed
when 36 patients are included; if a difference >15% of SSI (the short-term outcome) between
the 2 groups is put observed, the study will be terminated. A p-value <0.05 will be
considered as significant. Analyses will be performed using GraphPad Prism version 15 and
STATA version 13.
Discussion:
Existing literature reports heterogeneous incidences of incisional hernia at stoma site after
stoma closure. Several systematic reviews and meta-analyses, however, documented clinically
significant pooled incidences 1, 2. Considering that the incisional hernia usually requires
surgery and hospitalization, we believe that this complication, in addition to altering
patients' quality of life, also impairs healthcare systems budgets.
Preliminary studies have shown that insertion of a prophylactic mesh, resorbable or not,
during stoma closure, reduces the incidence of incisional hernia at stoma site 3, 4. However,
to date, no RCT has been released on the subject. Further, the procedure seems to be safe,
with very few SSI reported.
The aim of the present RCT will be to determine whether application of a prophylactic
non-absorbable mesh during stoma closure allows or not for the prevention of incisional
hernia at one year. Subgroup analysis will be performed according to the type of stoma and to
BMI class. Furthermore, secondary analysis of the results might allow us to gather enough
data for an objective cost-benefit analysis of the technique.
The strengths of the present RCT will be the following : (1) Good external validity due to
the representation of all types of stomas, (2) Mesh in the sublay position, where the risk of
intra-abdominal complications is lower and application is the easiest (as compared to
intra-abdominal mesh), (3) Use of an affordable mesh (as compared to biological mesh), (5)
assessment of the presence or not of incisional hernia by CTscan.
Trial status:
The RCT protocol was accepted by the local ethical committee.
