PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

Rectum Cancer Clinical Trial

Official title:

PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03445936
• Other study ID #: 317/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: October 2027

Study information

• Verified date: January 2024
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Description:

Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist. The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2027
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
• 18 years or older
• Patient has a life expectancy of at least 12 months.
• Patient signs the Informed consent and agrees to attend all study visits

Exclusion Criteria:

• Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
• Patients with concurrent or previous malignant tumors within 5 years before study enrollment
• Patients with T4b tumors which imposed a multi-organ resection
• Patient undergone emergency procedures
• Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
• Metastatic disease with life expectancy of less than 12 months
• Pregnancy or suspected pregnancy

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Rectal Neoplasms
• Rectum Cancer

Intervention

Device:
• Parietene Macro
Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
• Permacol
Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Locations

Country	Name	City	State
Finland	Jyvaskyla Central Hospital	Jyvaskyla
Finland	Oulu University Hospital	Oulu
Finland	Seinajoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	The incidence of surgical site infections at 30 days follow up	30 days
Primary	Incisional hernia	Incidence of incisional hernia	10 months
Secondary	Complications classified by Clavien-Dindo classification	Clavien-Dindo I-V complications at 30 days follow-up	30 days
Secondary	Re-operation rate	Demand for re-operations related to mesh or complications	5 years
Secondary	Operative time	Time (min) needed for operation and application of mesh/implant	30 days
Secondary	Length of stay	Length of stay at the hospital after the operation	30 days
Secondary	Quality of life measured by RAND-36 survey	Quality of life after the operation measured by RAND 36	5 years
Secondary	Incidence of hernia	Incidence of incisional hernia	5 years
Secondary	Cost analysis	Analysis of costs to both individual and community	5 years