Prestoma-Trial for Parastomal Hernia Prevention

Not Applicable

Terminated

• Conditions: Rectal Adenocarcinoma
• Interventions: Device: Parietene Macro; Device: Parietex Parastomal; Device: Dynamesh IPST

• Registration Number: NCT03527784
• Lead Sponsor: University of Oulu

Brief Summary

Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.

Detailed Description

Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.

Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.

Study Timeline

• Study First Submitted: 2018-05-02
• Study Start: 2018-05-03
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance
• 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

• Abdominoperineal resection by laparotomy or conversion to laparotomy
• Patient with a comorbid illness or condition that would preclude 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 impose a multi-organ resection
• Rectal malignancy other than adenocarcinoma
• Potentially curable resection not possible
• Patient undergoing emergency procedures
• Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
• Metastatic disease with life expectancy of less than 1 year
• Pregnant or suspected pregnancy
• Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parietene Macro	Parietene Macro	Parietene Macro is a macroporous synthetic mesh.
Parietex Parastomal	Parietex Parastomal	Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
Dynamesh IPST	Dynamesh IPST	Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.

Primary Outcome Measures

Name	Time	Method
Incidence of parastomal hernia	1 year	The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	5 years	Reoperation needed for any reason related to previous surgery
Surgical infections	30 days	Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.
Complications	30 days	The incidence of complications defined by Clavien-Dindo Classification
Stoma related complications	5 years	Any complications related to stoma
Quality of Life measured by RAND 36	5 years	Quality of life measured by The RAND 36-Item Health Survey 1.0 which assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions with a scale 0-100, higher the score, better the quality of life.
Operative time	30 days	Total time needed in operation theatre and time needed for mesh application
Length of stay	30 days	Length of stay at the hospital.

Trial Locations

Locations (6)

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Jyväskylä Central Hospital; 🇫🇮 Jyväskylä, Finland