NCT03527784

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

May 2, 2018

Last Update Submit

November 1, 2018

Conditions

Rectal Adenocarcinoma

Keywords

rectal adenocarcinomaabdominoperineal resectionhernia prophylaxis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Surgical infections

    30 days

  • Complications

    30 days

  • Stoma related complications

    5 years

  • Reoperation rate

    5 years

  • Operative time

    30 days

  • +2 more secondary outcomes

Study Arms (3)

Parietene Macro

ACTIVE COMPARATOR

Parietene Macro is a macroporous synthetic mesh.

Device: Parietene Macro

Parietex Parastomal

ACTIVE COMPARATOR

Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.

Device: Parietex Parastomal

Dynamesh IPST

ACTIVE COMPARATOR

Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.

Device: Dynamesh IPST

Interventions

Parietene MacroDEVICE

Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.

Parietene Macro
Parietex ParastomalDEVICE

Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.

Parietex Parastomal
Dynamesh IPSTDEVICE

Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia

Dynamesh IPST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Helsinki University Hospital

Helsinki, Finland

Location

Jyväskylä Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Elisa Mäkäräinen-Uhlbäck, M.D.

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subject is blinded of the mesh used. Outcome at 12 month follow-up is assessed by surgeon who was not involved in the operation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prestoma is a prospective randomized controlled multicenter trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 17, 2018

Study Start

May 3, 2018

Primary Completion

October 29, 2018

Study Completion

October 29, 2018

Last Updated

November 5, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(6)