Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure

NCT02896686 | Unknown Phase 4 DMC

• 1 other identifier: ILEOMESH
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer

Conditions

Incisional Hernia

Keywords

Ileostomy closure; Polypropylene Mesh; Incisional hernia

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 12 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).

  12 months

Secondary Outcomes (2)

• Perioperative complications

  30 days

• Quality of life of the patients

  3, 6 and 12 months after surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Abdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure

Radiation: Control CT; Other: Clinical Follow Up

Reinforcement with Mesh

EXPERIMENTAL

Abdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1. The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture. The skin will be closed using a subcutaneous purse-string closure

Radiation: Control CT; Other: Clinical Follow Up; Procedure: Reinforcement with Light Polypropylene Mesh

Interventions

Control CT RADIATION

At the end of the follow up (12 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the abdominal wall seen on the abdominal CT scan with the patient at rest. The radiologist is blinded to the patient's history and the technique used for fascial closure.

Control; Reinforcement with Mesh

Clinical Follow Up OTHER

The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.

Control; Reinforcement with Mesh

Reinforcement with Light Polypropylene Mesh PROCEDURE

Reinforcement with Light Polypropylene Mesh

Reinforcement with Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer.
• elective surgery for loop ileostomy closure
• ASA (American Society of Anesthesiologists)\<4

You may not qualify if:

• allergy or intolerance to polypropilene
• patients with a prior mesh on the abdominal wall
• ASA ≥IV
• patients with a life expectancy of \<12 months
• chronic renal failure in haemodialysis
• patients on steroid therapy

Sponsors & Collaborators

• Hospital Universitari Joan XXIII de Tarragona.: lead

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Aleidis Caro

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: September 12, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share