Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh

NCT04538768 | Unknown

• 1 other identifier: 20082020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.

Conditions

Incisional LLQ Hernia

Keywords

lateral incisional hernia; mesh augmentation; prevention; stomal closure

Outcome Measures

Primary Outcomes (1)

• rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.

  the outcome 1 will be assessed through clinical examination during follow up time. when the suspicion of incisional hernia will be hypothesized the patients will be conducted to perform US of the abdomen and CT scan of the abdomen if strictly required to confirm the suspicion.

  1 week to 18 months after surgery

Secondary Outcomes (7)

• surgical operation time in P4HB mesh placement group vs direct fascia suture group.

  intraoperative

• length of hospital stay in P4HB mesh placement group vs direct fascia suture group.

  From the starting date of the study until the date of its completion, assessed up to 18 months"

• rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.

  1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery

• rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.

  1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery

• rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.

  1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery

Study Arms (2)

Mesh Augmentated

EXPERIMENTAL

Procedure: Mesh augmentation

Direct Suture

OTHER

Procedure: Direct suture

Interventions

Mesh augmentation PROCEDURE

P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure

Mesh Augmentated

Direct suture PROCEDURE

direct fascia suture

Direct Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \> 18 y.o.
• stomal closure
• elective surgery

You may not qualify if:

• patients \< 18 y.o.
• emergency surgery

Sponsors & Collaborators

• Buccheri La Ferla Hospital, Palermo: lead

Study Sites (1)

Ospedale Buccheri La Ferla Palermo

Palermo, 90100, Italy

Location

Study Officials

• Leo Licari, MD

  Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral Sciences

  STUDY DIRECTOR

• Cosimo Callari, MD

  Ospedale Buccheri La Ferla Palermo

  STUDY CHAIR

Central Study Contacts

Leo Licari, MD

CONTACT

+39 3401710089; lele.licari@gmail.com

Cosimo Callari, MD

CONTACT

+39 339 4574404; cosimo.callari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 4, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2023
• Last Updated: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)