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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Ile

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 Summary:

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 assig
Sponsor: Hospital Universitari Joan XXIII de Tarragona.

Current Primary Outcome: Incidence of incisional hernia [ Time Frame: 12 months ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Joan XXIII de Tarragona.

Dates:
Date Received: April 16, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: September 9, 2016
Last Verified: September 2016