Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a pilot Study

Recruiting

Conditions: abdominal hernia
incisional hernia
ventral hernia
10000073

Registration Number: NL-OMON35152

Lead Sponsor: Algemene Heelkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is postoperative complications after<br /><br>prophylactic mesh placement around a stoma (i.e. infection of the mesh and<br /><br>adhesions to the mesh). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Optimizing operative procedures (size of mesh, size of opening in mesh,<br /><br>fixation)<br /><br>Postoperative complications (anastomotic dehiscence, fistula)<br /><br>Stoma complications (stenosis, bulging, prolapse, retraction, skin problems)<br /><br>Wound infection after stoma reversal<br /><br>Parastomal hernia incidence and incisional hernia incidence after stoma reversal<br /><br>Quality of Life and Pain score before and after stoma creation with mesh<br /><br>placement and after stoma reversal</p><br>