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NCT03953365 Clinical Trial

Prophylactic Mesh in Cytoreductive Surgery

Incisional Hernia Clinical Trial

Official title:
Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03953365
Other study ID # PI 19/41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date December 31, 2023

Study information
Verified date May 2019
Source Hospital Universitario Fundación Alcorcón
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 66
Est. completion date December 31, 2023
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Fundación Alcorcón

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Incisional Hernia Prevention of Incisional Hernia four years
See also
  Status Clinical Trial Phase
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Recruiting NCT05734222 - Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias N/A
Enrolling by invitation NCT03105895 - Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI N/A
Completed NCT02089958 - Standardization of Laparoscopic Hernia Repair N/A
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00498810 - COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL) N/A
Completed NCT04961346 - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair N/A
Terminated NCT03912662 - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention N/A
Recruiting NCT05620121 - ACute Treatment of Incisional Ventral Hernia
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Not yet recruiting NCT02896686 - Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure Phase 4
Recruiting NCT02277262 - PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM) Phase 4
Active, not recruiting NCT02328352 - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" Phase 1/Phase 2
Suspended NCT01520168 - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management N/A
Completed NCT05579652 - Change in Fascial Tension in Open Abdomens
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT02321059 - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia N/A