the Use of a IPOM Mesh for Prevention of Parastomal Hernia

Parastomal Hernia Clinical Trial

Official title:

Prospective, Randomized Study on the Use of a Intraperitoneal Onlay Mesh for Prevention of Parastomal Hernia of Permanent Colostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368873
• Other study ID #: 109/2009
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: February 20, 2015
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: February 2015
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study is a prospective, multicenter, randomized trial evaluating whether prophylactic laparoscopic placement of a dual-component IPOM mesh around a colostomy may prevent parastomal hernia compared with conventional colostomy after abdominoperineal resection. Eligible subjects will be recruited prospectively from five Finnish Hospitals (Oulu University Hospital,Vaasa Central Hospital, Helsinki University Hospital, Lahti Central Hospital, Jyväskylä Central Hospital). Patients were considered eligible for this study if undergoing laparoscopic abdominoperineal resection for rectal adenocarcinoma. Patients are randomized to prophylactic preperitoneal placement of a dual-component mesh (Dynamesh IPOM) around permanent colostomy or to conventional permanent colostomy. Estimating a parastomal hernia rate of 50%, a sample size of 26 patients per each study group is projected to provide 90% power (1-beta) with a alpha 0.05 (2-beta) to detect a 40% reduction in risk for parastomal hernia at 1-year. Since we expect a dropout rate of 20%, 37 patients per study group will be included in this study.

All abdominoperineal resections are performed using laparosopic technique. At the and of the abdominal laparoscopic phase the straight permanent end colostomy is performed. In the intervention group the 10 x 10 cm Dynamesh IPOM mesh is cut in the middle according to volume of the bowel. Stapled bowel end is then pulled through the crosswise opened mesh, which is pushed to the abdomen and fixed to the peritoneum.

Follow-up visits are scheduled at 1-, 3- and 12-month after surgery. Patients are evaluated for their clinical status and C-reactive protein, leukocytes and hemoglobin are assessed at each control visit. Computed tomography (CT) scan with and without Valsalva maneuver is performed 12 months after surgery for radiological evaluation of possible parastomal hernia.

The primary end-point of this study is the incidence of clinically and radiologically detected parastomal hernias, and their extent 12 months after surgery. The secondary outcome end-points were colostomy-related morbidity such as stomal stenosis, necrosis and/or wound infection.The extent of parastomal hernia was graded at CT according to the Hernia Society criteria.

Statistical analysis is performed using a SPSS statistical software. Continuous variables are reported as the mean and standard deviation, whereas nominal variables are reported as counts and proportions. Univariate analysis is performed with the Mann-Whitney U test and Fisher's exact test. P-values < 0.05 are considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing laparoscopic abdominoperineal resection for rectal adenocarsinoma

Exclusion Criteria:

• Patients who can not give their consent to participate in the study

• Patients in poor general conditions (American Society of Anaesthesiologists classes 4-5)

• Patients with incurable cancer or another rectal malignancy than adenocarcinoma

• Patients with any abdominal infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• Application of IPOM mesh

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Oulu University Hospital	Central Finland Hospital District, Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, Vaasa Central Hospital, Vaasa, Finland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of parastomal hernia		One year	No
Secondary	Number of colostomy-related complications		One year	Yes