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| Name | Class |
|---|---|
| Hitchcock Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh Implantation | Device | Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Efficacy Based on Number of Participants With Hernia Formation | 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. | 30 days, and then 6 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Z Wilson, MD, Msc | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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24 Adult patients with left-sided colon and rectal cancer treated with resection and diverting loop ileostomy were eligible to participate. 4 participants declined participation and were not enrolled.
Historical Controls. Data for only those who met the inclusion criteria was collected. Data collected was only relevant to the Primary endpoint, and additional follow-up date was no collected beyond the data needed for analysis for the primary outcome measure.
Adult patients (Interventional group)with left sided CRC who underwent proximal diversion with a LI as part of their surgical therapy were recruited from the clinical practice of the Division of Colon and Rectal Surgery at DHMC between January 2019 and November 2020.
Historical Controls were patients diagnosed with colorectal cancer and who underwent stoma reversals from January 1, 2011, to December 31, 2018 from the clinical practice of the Division of Colon and Rectal Surgery at DHMC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation |
| FG001 | Historical Controls | Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation |
| BG001 | Historical Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 30 days |
|
From date of surgery to follow-up at approximately 2 years.
Interventional arm: Adverse events were collected for surgical site occurrences (surgical site infection, mesh infection, delayed wound healing), fascial dehiscence, seroma, hematoma, cellulitis or enterocutaneous fistula, or return to the operating room for mesh removal.
Historical Controls: Only adverse events relating to wound or organ/space infection and wound disruption were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ogilvie's syndrome | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Z. Wilson, MD MSc FACS FASCRS | Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH Geisel School of Medicine, Hanover, NH | (603) 650-8113 | Matthew.Z.Wilson@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2020 | Jan 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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
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| Bowel Function After Mesh Implantation | 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. | 2 years |
| Quality of Life After Mesh Implantation | 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 | 2 years |
Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Preliminary Efficacy Based on Number of Participants With Hernia Formation | 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. | One participant was lost to follow-up due to declining cancer surveillance. | Posted | Count of Participants | Participants | 30 days, and then 6 months post procedure |
|
|
|
| Secondary | Bowel Function After Mesh Implantation | 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. | Posted | Mean | Full Range | units on a scale | 2 years |
|
|
|
| Secondary | Quality of Life After Mesh Implantation | 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 | Posted | Mean | Full Range | units on a scale | 2 years |
|
|
|
| 1 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Historical Controls | Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes. | 0 | 92 | 0 | 92 | 9 | 92 |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| superficial wound infection | Infections and infestations | Systematic Assessment |
|
| organ/space infection | Infections and infestations | Systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| organ/space infection |
|
| wound disruption |
|
|