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

Incisional Hernia Clinical Trial

— ILEOMESH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02896686
• Other study ID #: ILEOMESH
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 16, 2016
• Last updated: September 9, 2016
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2016
• Source: Hospital Universitari Joan XXIII de Tarragona.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 157
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.

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.

Procedure:
• Reinforcement with Light Polypropylene Mesh
Reinforcement with Light Polypropylene Mesh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Joan XXIII de Tarragona.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Perioperative complications	Secondary endpoints are perioperative complications, including wound infection, hematoma, pain and reoperation.	30 days	Yes
Secondary	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	Yes