Clinical trial NCT04749329: Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.
Official title: Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parastomal Hernia
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Binary outcome superiority trial. The sample size was calculated by Sealed Envelope Ltd. 2012. The calculation was based on the evaluation of PH rate at 3, 6, 12 and 24 months postoperatively in patients undergoing colostomy. In literature same trials reported a decrease in the incidence of PH in the mesh groups versus suture alone (xx). Therefore, we hypothesized a decrease of PH between Control and Mesh group of 25% (from 35 % to 10%). It was estimated that 49 subjects per group would be required to detect an absolute improvement of 25% (35% vs 10%) in the primary outcome between the two groups, with two-tailed α of 0.05 (2-sided 5% significance level) and a power of 80%. Data analysis was conducted according to an intention-to-treat approach. Loss to follow-up was estimated in about 10% of included patients. Therefore, a total of 110 patients (55 for each group) were included in the study.
Primary purpose: PREVENTION

Brief summary: The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Detailed description: Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* endo colostomy
* Informed consent

Exclusion Criteria:

* age \< 18 years;
* life expectancy \< 24 months (as estimated by the operating surgeon)
* pregnancy
* immunosuppressant therapy within 2 weeks before surgery

Primary outcomes:
measure: Rate of Parastomal Hernia at clinical control.
timeFrame: 3 months
measure: Rate of Parastomal Hernia at clinical control.
timeFrame: 6 months
measure: Rate of Parastomal Hernia at clinical control.
timeFrame: 12 months
measure: Rate of Parastomal Hernia at clinical control.
timeFrame: 24 months
Secondary outcomes:
measure: Rate of Parastomal Hernia at tomography observation.
timeFrame: 3 months follow-up
measure: Rate of Parastomal Hernia at tomography observation.
timeFrame: 6 months follow-up
measure: Rate of Parastomal Hernia at tomography observation.
timeFrame: 12 months follow-up
measure: Rate of Parastomal Hernia at tomography observation.
timeFrame: 24 months follow-up
measure: Number of patients affected by Superficial surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Deep surgical site infections
timeFrame: Within 30 days postoperatively
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Aslnapoli2Nord
city: Naples
country: Italy
facility: francesco Pizza
Study officials:
affiliation: Azienda Sanitaria Locale Napoli 2 Nord
name: Francesco Pizza, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: