Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Mar 27, 2024; 16(3): 823-832
Published online Mar 27, 2024. doi: 10.4240/wjgs.v16.i3.823
Reinforced tissue matrix to strengthen the abdominal wall following reversal of temporary ostomies or to treat incisional hernias
Spencer P Lake, Corey R Deeken, Amit K Agarwal
Spencer P Lake, Mechanical Engineering & Materials Science, Washington University in St. Louis, St. Louis, MO 63130, United States
Corey R Deeken, Covalent Bio, LLC, St. Louis, MO 63025, United States
Amit K Agarwal, Department of Surgery, McGovern Medical School at UTHealth, Houston, TX 77026, United States
Author contributions: Agarwal AK designed the study; Agarwal AK performed the research; Agarwal AK, Lake SP, and Deeken CR analyzed the data and wrote the manuscript; and all authors have read and approve the final manuscript.
Institutional review board statement: This study was reviewed and approved by the UT Health Houston Institutional Review Board (approval No. HSC-MS-23-0471).
Informed consent statement: All study participants, or their legal guardian, provided consent prior to study enrollment.
Conflict-of-interest statement: This project was sponsored by TELA Bio of Malvern, PA (USA). Dr. Deeken is the owner of Covalent Bio, LLC, which received consulting fees from TELA Bio for this project, as well as other unrelated projects. Dr. Deeken also reports consulting fees from C.R. Bard, Inc./Davol/Becton, Dickinson and Company, Johnson & Johnson, Medtronic, SurgiMatrix, Tissium, Surgical Innovation Associates, Americas Hernia Society Quality Collaborative, Colorado Therapeutics, TELA Bio, Osteogenics, Polynovo, MedSkin Solutions, and Aran Biomedical outside the submitted work. In addition, Dr. Deeken holds the following issued patents: 2009293001, 2334257, 2,334,257UK, 602009046407.8, 2,334,257FR, 16/043,849 and 2,737,542. Dr. Lake is a consultant for Covalent Bio LLC and has received consulting fees from TELA Bio for the conduct of this study, as well as outside of the current work. Dr. Agarwal is a paid consultant for TELA Bio.
Data sharing statement: Dataset available from the corresponding author.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Amit K Agarwal, FACS, FASCRS, MD, Associate Professor, Department of Surgery, McGovern Medical School at UTHealth, 5656 Kelley Street, General Surgery Office, Houston, TX 77026, United States. amit.k.agarwal@uth.tmc.edu
Received: October 27, 2023
Peer-review started: October 27, 2023
First decision: December 6, 2023
Revised: January 3, 2024
Accepted: February 25, 2024
Article in press: February 25, 2024
Published online: March 27, 2024
Abstract
BACKGROUND

Abdominal wall deficiencies or weakness are a common complication of temporary ostomies, and incisional hernias frequently develop after colostomy or ileostomy takedown. The use of synthetic meshes to reinforce the abdominal wall has reduced hernia occurrence. Biologic meshes have also been used to enhance healing, particularly in contaminated conditions. Reinforced tissue matrices (RTMs), which include a biologic scaffold of native extracellular matrix and a synthetic component for added strength/durability, are designed to take advantage of aspects of both synthetic and biologic materials. To date, RTMs have not been reported to reinforce the abdominal wall following stoma reversal.

AIM

To evaluate the effectiveness of using an RTM to reinforce the abdominal wall at stoma takedown sites.

METHODS

Twenty-eight patients were selected with a parastomal and/or incisional hernia who had received a temporary ileostomy or colostomy for fecal diversion after rectal cancer treatment or trauma. Following hernia repair and proximal stoma closure, RTM (OviTex® 1S permanent or OviTex® LPR) was placed to reinforce the abdominal wall using a laparoscopic, robotic, or open surgical approach. Post-operative follow-up was performed at 1 month and 1 year. Hernia recurrence was determined by physical examination and, when necessary, via computed tomography scan. Secondary endpoints included length of hospital stay, time to return to work, and hospital readmissions. Evaluated complications of the wound/repair site included presence of surgical site infection, seroma, hematoma, wound dehiscence, or fistula formation.

RESULTS

The observational study cohort included 16 male and 12 female patients with average age of 58.5 years ± 16.3 years and average body mass index of 26.2 kg/m2 ± 4.1 kg/m2. Patients presented with a parastomal hernia (75.0%), incisional hernia (14.3%), or combined parastomal/incisional hernia (10.7%). Using a laparoscopic (53.6%), robotic (35.7%), or open (10.7%) technique, RTMs (OviTex® LPR: 82.1%, OviTex® 1S: 17.9%) were placed using sublay (82.1%) or intraperitoneal onlay (IPOM; 17.9%) mesh positioning. At 1-month and 1-year follow-ups, there were no hernia recurrences (0%). Average hospital stays were 2.1 d ± 1.2 d and return to work occurred at 8.3 post-operative days ± 3.0 post-operative days. Three patients (10.7%) were readmitted before the 1-month follow up due to mesh infection and/or gastrointestinal issues. Fistula and mesh infection were observed in two patients each (7.1%), leading to partial mesh removal in one patient (3.6%). There were no complications between 1 month and 1 year (0%).

CONCLUSION

RTMs were used successfully to treat parastomal and incisional hernias at ileostomy reversal, with no hernia recurrences and favorable outcomes after 1-month and 1-year.

Keywords: Reinforced tissue matrix, Reinforced forestomach matrix, Ileostomy, Colostomy, Ostomy takedown, Incisional hernia, Abdominal wall

Core Tip: Reinforced tissue matrices (RTMs), which include elements of both synthetic and biologic mesh materials, were shown to be effective in treating parastomal and incisional hernia following ileostomy or colostomy reversal. Twenty-eight patients received OviTex® RTM to reinforce the abdominal wall using a laparoscopic, robotic, or open surgical approach. Positive primary outcomes (i.e., 0% hernia recurrence) and low rates of complications were observed at 1-month and 1-year follow-up.