Prestoma-Trial for Parastomal Hernia Prevention

Rectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03527784
• Other study ID #: 85/2018
• Status: Terminated
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: October 29, 2018

Study information

• Verified date: November 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Hernia
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Device:
• Parietene Macro
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
• Parietex Parastomal
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
• Dynamesh IPST
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Jyväskylä Central Hospital	Jyväskylä
Finland	Oulu University Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

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