Prestoma-Trial for Parastomal Hernia Prevention

PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma

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.

Study Overview

• Status: Terminated
• Conditions: Rectal Adenocarcinoma
• Intervention / Treatment: Device: Parietene Macro; Device: Parietex Parastomal; Device: Dynamesh IPST

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Jyväskylä, Finland
    • Jyväskylä Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Parietene Macro; Parietene Macro is a macroporous synthetic mesh.	Device: Parietene Macro; Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
ACTIVE_COMPARATOR: Parietex Parastomal; Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.	Device: Parietex Parastomal; Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
ACTIVE_COMPARATOR: Dynamesh IPST; Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.	Device: Dynamesh IPST; Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical infections	Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.	30 days
Complications	The incidence of complications defined by Clavien-Dindo Classification	30 days
Stoma related complications	Any complications related to stoma	5 years
Reoperation rate	Reoperation needed for any reason related to previous surgery	5 years
Operative time	Total time needed in operation theatre and time needed for mesh application	30 days
Length of stay	Length of stay at the hospital.	30 days
Quality of Life measured by RAND 36	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.	5 years

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2018
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): October 29, 2018

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: rectal adenocarcinoma; abdominoperineal resection; hernia prophylaxis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Hernia; Adenocarcinoma; Rectal Neoplasms
• Other Study ID Numbers: 85/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No