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

NCT ID: NCT02896686

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

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

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.

Conditions

Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Control CT

Intervention Type: 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.

Clinical Follow Up

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Control CT

Intervention Type: 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.

Clinical Follow Up

Intervention Type: 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.

Reinforcement with Light Polypropylene Mesh

Intervention Type: PROCEDURE

Reinforcement with Light Polypropylene Mesh

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Reinforcement with Light Polypropylene Mesh

Reinforcement with Light Polypropylene Mesh

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Joan XXIII de Tarragona.

OTHER

Sponsor Role: lead

Responsible Party

Aleidis Caro

PhD Aleidis Caro

Responsibility Role: PRINCIPAL_INVESTIGATOR

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

ILEOMESH

Identifier Type: -

Identifier Source: org_study_id