Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.

NCT04749329 | Unknown

• 1 other identifier: 212128
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Parastomal Hernia

Outcome Measures

Primary Outcomes (4)

• Rate of Parastomal Hernia at clinical control.

  Detect of paratoia hernia

  3 months

• Rate of Parastomal Hernia at clinical control.

  Detect of paratoia hernia

  6 months

• Rate of Parastomal Hernia at clinical control.

  Detect of paratoia hernia

  12 months

• Rate of Parastomal Hernia at clinical control.

  Detect of paratoia hernia

  24 months

Secondary Outcomes (6)

• Rate of Parastomal Hernia at tomography observation.

  3 months follow-up

• Rate of Parastomal Hernia at tomography observation.

  6 months follow-up

• Rate of Parastomal Hernia at tomography observation.

  12 months follow-up

• Rate of Parastomal Hernia at tomography observation.

  24 months follow-up

• Number of patients affected by Superficial surgical site infections

  Within 30 days postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

no mesh was used for end colostomy fashions

Mesh Group

EXPERIMENTAL

Mesh of Bio A was used for end colostomy fashions

Device: Mesh Group

Interventions

Mesh Group DEVICE

All MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass. An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients.

Mesh Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (2)

Aslnapoli2Nord

Naples, 80131, Italy

RECRUITING

francesco Pizza

Naples, 80131, Italy

NOT YET RECRUITING

Study Officials

• Francesco Pizza, Md, PhD

  Azienda Sanitaria Locale Napoli 2 Nord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pizza, Md, PhD

CONTACT

3338275449; francesco_pizza@libero.it

Francesco Pizza, Md, PhD

CONTACT

3338275449; francesco.pizza@laslnapoli2nord.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients were randomized in two groups (Control Group, without mesh; Mesh Group, receiving Bio-A mesh supported colostomy in an ante rectus fashion). Participants were randomly allocated to one of the two groups using computer-generated permuted blocks (www.randomization.com), just before colostomy fashion. For each patient, an identification number was generated. This latter was utilized during all the follow-up period guarantying the blinding process. Patients, care providers, staff collecting data and those assessing the endpoints, in fact, we're all blinded to group allocation. Because the blinding of the operating surgeons was not feasible, they were not involved in the
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Bariatric Unit

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 11, 2021
• Study Start: August 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)