We would like to conduct a RCT to confirm the hernia prevention effect of a mesh, however in a slightly different position, with a different mesh and with all types of stomas. In addition, we want to measure the possible benefit in terms of quality…
ID
Source
Brief title
Condition
- Abdominal hernias and other abdominal wall conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is postoperative complications after
prophylactic mesh placement around a stoma (i.e. infection of the mesh and
adhesions to the mesh).
Secondary outcome
Optimizing operative procedures (size of mesh, size of opening in mesh,
fixation)
Postoperative complications (anastomotic dehiscence, fistula)
Stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Wound infection after stoma reversal
Parastomal hernia incidence and incisional hernia incidence after stoma reversal
Quality of Life and Pain score before and after stoma creation with mesh
placement and after stoma reversal
Background summary
Parastomal hernias and incisional hernias in old stoma wounds develop
frequently (30-50%) and carry along a significant burden of disease. The idea
of a prophylactic mesh has been tested in a Swedish randomized controlled trial
(RCT) with the mesh placed upon end colostomy formation. Results suggest this
procedure is the panacea against stoma associated herniations. To our knowledge
however, the technique is not being applied yet in our or other centres,
probably because we still have unanswered questions about the size and ideal
position of the mesh, possible complications (infection, adhesions) and the
benefit in terms of quality of life.
Study objective
We would like to conduct a RCT to confirm the hernia prevention effect of a
mesh, however in a slightly different position, with a different mesh and with
all types of stomas. In addition, we want to measure the possible benefit in
terms of quality of life. However, before setting up this RCT we first want to
conduct a pilot study of 10 patients to determine the safety (i.e. infection,
adhesions) of mesh placement and fine-tune logistics and the operative
procedure.
Study design
Pilot intervention study.
Intervention
Placing an intraperitoneal mesh around the stoma at stoma creation.
Study burden and risks
Knowing that the risk of herniation (parastomal or incisional) is 30-50% and
the associated morbidity significant, standard placement of a prophylactic mesh
might improve the quality of life of a large group of patients. This study is
meant to be a pilot study to see whether the mesh related risks of infection
and adhesion morbidity are acceptable. To minimize the risk of infection, only
patients without any immunocompromise will participate. This study will also
identify the ideal surgical technique and assess problems and/or
impracticalities of the protocol for the future RCT.
Patients will furthermore undergo their standard treatment with the addition of
a mesh placed upon stoma formation. The burden for the patients will be
answering the quality of life questions. Since most patients will be
oncological patients the number of outpatient follow-up visits will only be
incremented by one.
When we compare the potential benefit of a large group of patients receiving
this intervention with the potential detrimental effects, we find the former
outweighing the latter.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
- life expectancy at least 1 year
- temporary stoma
- elective surgery
- clean-contaminated abdomen (GI-tract opened)
Exclusion criteria
- ASA score IV or above
- Incapacitated adult or no signed informed consent
- Emergency procedure
- Contaminated or infected* abdomen
- Residual intraperitoneal mesh
- Already injured part of the abdominal wall where the stoma will be sited
- Contraindication to laparoscopy
- Longterm use of corticosteroids and other immunosuppressive agents
- Current antibiotic therapy
- Currently receiving or recently received chemotherapy
- Immune deficiency, ascites, peritoneal dialysis, pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00907842 |
| CCMO | NL27625.068.09 |