Trial Outcomes & Findings for Stoma Closure and Reinforcement Trial (NCT NCT03750461)

Last Updated: 2023-02-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

30 days

Results posted on

2023-02-22

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	20	92
Overall Study Primary Endpoint	20	92
Overall Study Secondary Endpoint	19	0
Overall Study COMPLETED	19	0
Overall Study NOT COMPLETED	1	92

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stoma Closure and Reinforcement Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants 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	Historical Controls n=92 Participants 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.	Total n=112 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	58 years n=7 Participants	60 years n=5 Participants
Age, Customized Mean	62 years n=5 Participants	58 years n=7 Participants	120 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	81 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	91 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	92 participants n=7 Participants	112 participants n=5 Participants
Body mass index (BMI)	29.19 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.95 • n=7 Participants	28.245 kg/m^2 STANDARD_DEVIATION 6.425 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants 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	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.
Number of Participants With Wound Occurrences	0 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants 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	Historical Controls n=92 Participants 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.
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls superficial wound infection	0 participants	5 participants
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls deep wound infection	0 participants	0 participants
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls organ/space infection	0 participants	4 participants
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls wound disruption	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days, and then 6 months post procedure

Population: One participant was lost to follow-up due to declining cancer surveillance.

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.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants 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	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.
Preliminary Efficacy Based on Number of Participants With Hernia Formation 30 Days post procedure	0 Participants	—
Preliminary Efficacy Based on Number of Participants With Hernia Formation 6 months post procedure	0 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants 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	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.
Bowel Function After Mesh Implantation	12 units on a scale Interval 10.0 to 30.0	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants 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	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.
Quality of Life After Mesh Implantation	33 units on a scale Interval 15.0 to 40.0	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Historical Controls

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=20 participants at risk 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	Historical Controls n=92 participants at risk 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.
Gastrointestinal disorders Ogilvie's syndrome	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/92 • 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.
Cardiac disorders Myocardial infarction	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/92 • 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.
Infections and infestations superficial wound infection	0.00% 0/20 • 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.	5.4% 5/92 • Number of events 5 • 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.
Infections and infestations organ/space infection	0.00% 0/20 • 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.	4.3% 4/92 • Number of events 4 • 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.

Additional Information

Matthew Z. Wilson, MD MSc FACS FASCRS

Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH Geisel School of Medicine, Hanover, NH

Phone: (603) 650-8113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place