Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh

NCT04510558 | Unknown

• 1 other identifier: PROMESH TRIAL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure. Methods/Design: The study will be a randomized controlled single-blinded monocentric study determining the 1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy closure with or without prophylactic non-absorbable mesh applied in the sublay position. Discussion: Prevention of incisional hernia at site of stoma closure will lead to an improvement in patients' quality of life and generating savings for healthcare systems. To date, no randomized controlled trial assessing the effect of prophylactic mesh applied during stoma closure on the prevention of incisional hernia has been published. With the present randomized controlled trial, we expect to demonstrate that the application of a prophylactic mesh reduces the one-year incidence of incisional hernia at site of stoma closure.

Conditions

Incisional Hernia

Keywords

mesh; ileostomy; colostomy; stoma closure

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia at site of stoma at one year after closure

  The presence or not of an incisional hernia will be assessed clinically by a specialist in general surgery and radiologically by computed tomography realized in the setting of cancer followup. The investigator performing the 1-year follow-up and the radiologist interpreting the CTscan will be blinded for the study group. Patients diagnosed with incisional hernia and/or reoperated for a complication related to stoma closure and/or mesh will be considered as treatment failure.

  At one year after stoma closure

Secondary Outcomes (1)

• Incidence of surgical site infection (SSI) at site of stoma closure

  At seven days and 31 days after stoma closure

Study Arms (2)

Intervention (mesh)

EXPERIMENTAL

Insertion of a non-resorbable mesh in the subway position.

Device: Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position

Control (no mesh)

SHAM COMPARATOR

No insertion of mesh.

Procedure: Stoma closure without mesh

Interventions

Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position DEVICE

* Antibioprophylaxis using cefuroxime and metronidazole * Standard disinfection and sterile draping * Circular incision around the stoma using the scalpel blade * Dissection around the stoma until entering the abdominal cavity * Closure of the stoma using a linear stapler * A midline laparotomy may be performed or not * Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis * Closure of the posterior aponeurosis using separate Maxon 2-0 stitches * Application of an ULTRAPRO Advanced Mesh, Ethicon, Johnson \& Johnson, with +2cm on the edges, secured by 4 stiches of Maxon 2-0 * Closure of the anterior aponeurosis using separate Maxon 2-0 stitches * No subcutaneous stitches * Partial purse string skin closure using Monocryl 3-0 * Standard wound dressing

Intervention (mesh)

Stoma closure without mesh PROCEDURE

* Antibioprophylaxis using cefuroxime and metronidazole * Standard disinfection and sterile draping * Circular incision around the stoma using the scalpel blade * Dissection around the stoma until entering the abdominal cavity * Closure of the stoma using a linear stapler * A midline laparotomy may be performed or not * Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis * Closure of the posterior aponeurosis using separate Maxon 2-0 stitches * Closure of the anterior aponeurosis using separate Maxon 2-0 stitches * No subcutaneous stitches * Partial purse string skin closure using Monocryl 3-0 * Standard wound dressing

Control (no mesh)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Ileostomy or colostomy performed during surgery for digestive cancer
• Planned elective closure of ileostomy or colostomy
• Informed written consent

You may not qualify if:

• Allergy to the mesh
• Patients under corticosteroids or other immunosuppressive treatment
• Inability/refusal to follow the procedures of the study

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Meyer J, Delaune V, Abbassi Z, Douissard J, Toso C, Ris F, Buchs N. PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial. BMJ Open. 2021 Dec 14;11(12):e053751. doi: 10.1136/bmjopen-2021-053751.

  PMID: 34907065 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Nicolas Buchs, MD, PD

  University Hospitals of Geneva

  STUDY DIRECTOR

Central Study Contacts

Jeremy Meyer, MD, MD-PhD

CONTACT

+41795533182; jeremy.meyer@unige.ch

Vaihere Delaune, MD-PhD

CONTACT

vaihere.delaune@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded for the study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon

Model Details: Patients will be recruited during the preoperative consultation. Patients will be given written information related to the study and will sign an informed consent form. Investigators will be contacted and perform randomization using the RedCap (Research Electronic Data Capture) software system on a 1:1 allocation ratio between study groups. The surgery planning form will be forwarded to the investigators, which will indicate if a mesh should be added or not to the stoma closure procedure.

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)