Stoma Closure and Reinforcement Trial

NCT03750461 | Completed Results DMC FDA Device

• 1 other identifier: D18101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of large pore monofilament polypropylene mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.

Conditions

Colon Cancer; Rectal Cancer; Ileostomy - Stoma

Keywords

ileostomy; hernia; rectal cancer; colon cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Wound Occurrences

  Incidence of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.

  30 days

• Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls

  The incidence of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.

  30 days

Secondary Outcomes (3)

• Preliminary Efficacy Based on Number of Participants With Hernia Formation

  30 days, and then 6 months post procedure

• Bowel Function After Mesh Implantation

  2 years

• Quality of Life After Mesh Implantation

  2 years

Study Arms (1)

Intervention

EXPERIMENTAL

Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Device: Mesh Implantation

Interventions

Mesh Implantation DEVICE

Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation

Intervention

Eligibility Criteria

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

You may qualify if:

• Age \> 18years
• Patient is undergoing closure of loop ileostomy
• Patient has a diagnosis of left sided colon or rectal cancer treated with resection and diverting loop ileostomy
• Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery

You may not qualify if:

• Pre-existing systemic infection at the time of ileostomy takedown
• Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
• On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \>10mg/day)
• Previous abdominal hernia repair with mesh placement
• Concurrent procedures in addition to closure of diverting loop ileostomy
• Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Hitchcock Foundation: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Hernia

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew Z. Wilson, MD MSc FACS FASCRS
• Organization: Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH Geisel School of Medicine, Hanover, NH

Matthew.Z.Wilson@hitchcock.org

(603) 650-8113

Study Officials

• Matthew Z Wilson, MD, Msc

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 23, 2018
• Study Start: January 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: February 1, 2023
• Last Updated: February 22, 2023
• Results First Posted: March 10, 2022

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)