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

Multicentric, Prospective, Randomized and Simple Blind Study to Determine the Efficacy of the Placement of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure in Patients With a Prior Rectal Resection for Cancer

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

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Other: Clinical Follow Up; Radiation: Control CT; Procedure: Reinforcement with Light Polypropylene Mesh

Detailed Description

The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and 12 months after surgery and by abdominal CT scan one year after stoma closure.

Secondary aims are to evaluate the tolerability and safety of the prothesis; complications, quality of life and the need for further treatments will be compared between the groups.

This is a multicentric study that will include 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 with ASA<4. Exclusion criteria include patients with allergy or intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with a life expectancy of <12 months, chronic renal failure in haemodialysis and patients on steroid therapy.

Patients that agree to participate in the study will be randomized using an electronic formula (Excel) of a uniformly distributed variable assigning case/control randomly until the total number of patients are included.

In the control group, after the digestive tract is reconstructed, the closure of the abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins 4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in the study group will have the same procedure performed, and after the aponeurosis closure with PDS loop, an onlay light polypropilene mesh will be placed.

Each participant will have an assigned code depending on the participating Centre that will maintain anonymity at all times. All of the information will be registered in a database specifically designed for the study.

Statistical analysis will be performed by a descriptive study of the demographic variables and the incidence of incisional hernia after loop ileostomy closure. A comparative study between the groups will be performed using X2 test for categorical variables and t Student test or U-Mann for continuous variables. A binary logistic regression will also be performed to analyse the influence of each variable and to predict if the interventions produce incisional hernia.

• Study Type: Interventional
• Enrollment (Anticipated): 157
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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	Other: Clinical Follow Up; 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.; Radiation: Control CT; 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.
Experimental: Reinforcement with Mesh; 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	Other: Clinical Follow Up; 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.; Radiation: Control CT; 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.; Procedure: Reinforcement with Light Polypropylene Mesh; Reinforcement with Light Polypropylene Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	Secondary endpoints are perioperative complications, including wound infection, hematoma, pain and reoperation.	30 days
Quality of life of the patients	The quality of life was evaluated by the SF-36 Quality of life test, during scheduled clinical visits over a period of 12 months.	3, 6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitari Joan XXIII de Tarragona.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: April 16, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Incisional hernia; Ileostomy closure; Polypropylene Mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: ILEOMESH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol