Colon Cancer, Ileostomy - Stoma, Rectal Cancer
Conditions
Keywords
ileostomy, hernia, rectal cancer, colon cancer
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.
Interventions
DEVICEMesh Implantation
Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation
Sponsors
Hitchcock Foundation
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18years 2. Patient is undergoing closure of loop ileostomy 3. Patient has a diagnosis of left sided colon or rectal cancer treated with resection and diverting loop ileostomy 4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery
Exclusion criteria
1. Pre-existing systemic infection at the time of ileostomy takedown 2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder 3. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \>10mg/day) 4. Previous abdominal hernia repair with mesh placement 5. Concurrent procedures in addition to closure of diverting loop ileostomy 6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Occurrences | 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. |
| Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | 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
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Efficacy Based on Number of Participants With Hernia Formation | 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. |
| Bowel Function After Mesh Implantation | 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. |
| Quality of Life After Mesh Implantation | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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. | 92 |
| Total | 112 |
Baseline characteristics
| Characteristic | Intervention | Historical Controls | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 58 years | 60 years |
| Age, Customized Mean | 62 years | 58 years | 120 years |
| Body mass index (BMI) | 29.19 kg/m^2 STANDARD_DEVIATION 7.9 | 27.3 kg/m^2 STANDARD_DEVIATION 4.95 | 28.245 kg/m^2 STANDARD_DEVIATION 6.425 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 91 Participants | 110 Participants |
| Region of Enrollment United States | 20 participants | 92 participants | 112 participants |
| Sex: Female, Male Female | 8 Participants | 81 Participants | 89 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 0 / 92 |
| other Total, other adverse events | 2 / 20 | 9 / 92 |
| serious Total, serious adverse events | 0 / 20 | 0 / 92 |
Outcome results
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Wound Occurrences | 0 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.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | organ/space infection | 0 participants |
| Intervention | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | superficial wound infection | 0 participants |
| Intervention | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | wound disruption | 0 participants |
| Intervention | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | deep wound infection | 0 participants |
| Historical Controls | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | wound disruption | 0 participants |
| Historical Controls | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | organ/space infection | 4 participants |
| Historical Controls | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | deep wound infection | 0 participants |
| Historical Controls | Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | superficial wound infection | 5 participants |
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Bowel Function After Mesh Implantation | 12 units on a scale |
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.
Time frame: 30 days, and then 6 months post procedure
Population: One participant was lost to follow-up due to declining cancer surveillance.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Preliminary Efficacy Based on Number of Participants With Hernia Formation | 30 Days post procedure | 0 Participants |
| Intervention | Preliminary Efficacy Based on Number of Participants With Hernia Formation | 6 months post procedure | 0 Participants |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Quality of Life After Mesh Implantation | 33 units on a scale |