Prestoma-Trial for Parastomal Hernia Prevention

Sponsor

University of Oulu (Other)

Overall Status

Terminated

CT.gov ID

NCT03527784

Collaborator

(none)

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

2.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Adenocarcinoma	Device: Parietene Macro Device: Parietex Parastomal Device: Dynamesh IPST	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prestoma is a prospective randomized controlled multicenter trial.Prestoma is a prospective randomized controlled multicenter trial.

Masking:

Single (Participant)

Masking Description:

Subject is blinded of the mesh used. Outcome at 12 month follow-up is assessed by surgeon who was not involved in the operation.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 3, 2018

Actual Primary Completion Date :

Oct 29, 2018

Actual Study Completion Date :

Oct 29, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
Reoperation rate [5 years]
Reoperation needed for any reason related to previous surgery
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Helsinki University Hospital	Helsinki	Finland
2	Jyväskylä Central Hospital	Jyväskylä	Finland
3	Oulu University Hospital	Oulu	Finland
4	Seinäjoki Central Hospital	Seinäjoki	Finland
5	Tampere University Hospital	Tampere	Finland
6	Turku University Hospital	Turku	Finland