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Completed

NCT Number: NCT03750461

Stoma Closure and Reinforcement Trial

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hernia Ileostomy - Stoma Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Mesh Implantation

Device

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

Primary outcomes

  1. Number of Participants With Wound Occurrences

    Time frame: 30 days

    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.

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

    Time frame: 30 days

    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.

Secondary outcomes

  1. Preliminary Efficacy Based on Number of Participants With Hernia Formation

    Time frame: 30 days, and then 6 months post procedure

    Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.

  2. Bowel Function After Mesh Implantation

    Time frame: 2 years

    Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.

  3. Quality of Life After Mesh Implantation

    Time frame: 2 years

    Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Hitchcock Foundation

Registry information

Official study title

Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients

Acronym: SCAR

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Nov 23, 2018
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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