NCT03953365

Brief Summary

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Status
unknown

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 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 14, 2019

Last Update Submit

May 15, 2019

Conditions

Incisional Hernia

Keywords

hyperthermic intraperitoneal chemotherapycytoreduction surgeryprophylactic mesh

Outcome Measures

Primary Outcomes (1)

  • Rate of Incisional Hernia

    Prevention of Incisional Hernia

    four years

Study Arms (2)

without mesh

NO INTERVENTION

Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh

with mesh

OTHER

Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh

Procedure: Prophylactic Mesh

Interventions

Prophylactic MeshPROCEDURE

Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

with mesh

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1

You may not qualify if:

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDICAL DOCTOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

June 1, 2019

Primary Completion

May 31, 2021

Study Completion

December 31, 2023

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share