Gastrointestinal Disease, Colorectal Disease
Conditions
Keywords
Stapling, hand sutured anastamosis, colorectal disease
Brief summary
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
Interventions
PROCEDURESuturing
Suturing
PROCEDUREAdvant 55 Linear Cutter/Stapler
Advant 55 Linear Cutter/Stapler
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
a. * Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document * 18 years to 75 years (inclusive) * Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis * Willing to adhere to standard postoperative care, including ventilator support if required * Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation) * If female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or IUD) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure * Absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations.
Exclusion criteria
* Women of childbearing potential who are pregnant at the time of screening or at the time of surgery * Subject is on treatment with Corticosteroid maintenance therapy (equivalent to \> 10mg/day of Prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period * Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of \> 3mg/dL * Subject has liver failure as evidenced by CP category C * Immunocompromised subjects (hematological malignancies, history of bone marrow transplantation, splenectomized subjects, genetic disorders such as Lupus, severe combined immunodeficiency, etc.) or a positive HIV test result * Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment * Any subject that the investigator determines is not likely to be compliant during the study period * Subjects determined or suspected to engage in substance abuse, or any subject who is currently, or has in the past 6 months, undergone substance abuse therapy * The investigator feels that the primary anastomosis is not feasible due to local conditions of the bowel or subject has unstable hemodynamic status requiring stoma * Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of Surgery (Skin Open to Skin Close) | Day 1 |
| Time of Anastomosis | Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I) |
| Return to Bowel Activity | Number of days post-surgery to appearance of peristaltic movement |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stapling | 142 |
| Suturing 4 layered hand-sutured anastomosis | 138 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 7 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Suturing | Stapling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 18 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 128 Participants | 124 Participants | 252 Participants |
| Age Continuous | 43.7 years STANDARD_DEVIATION 15.87 | 43.8 years STANDARD_DEVIATION 13.81 | 43.8 years STANDARD_DEVIATION 14.86 |
| Region of Enrollment India | 138 participants | 142 participants | 280 participants |
| Sex: Female, Male Female | 56 Participants | 64 Participants | 120 Participants |
| Sex: Female, Male Male | 82 Participants | 78 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 142 | 21 / 138 |
| serious Total, serious adverse events | 9 / 142 | 8 / 138 |
Outcome results
Primary
Return to Bowel Activity
Time frame: Number of days post-surgery to appearance of peristaltic movement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suturing | Return to Bowel Activity | 4.2 days | Standard Error 0.71 |
| Stapling | Return to Bowel Activity | 4.0 days | Standard Error 0.71 |
p-value: 0.777495% CI: [-0.2, 0.6]ANOVA
Primary
Time of Anastomosis
Time frame: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suturing | Time of Anastomosis | 20.6 minutes | Standard Error 1.9 |
| Stapling | Time of Anastomosis | 17.6 minutes | Standard Error 1.9 |
p-value: 0.000895% CI: [1.4, 4.5]ANOVA
Primary
Time of Surgery (Skin Open to Skin Close)
Time frame: Day 1
Population: Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suturing | Time of Surgery (Skin Open to Skin Close) | 168.4 minutes | Standard Error 47.4 |
| Stapling | Time of Surgery (Skin Open to Skin Close) | 172.7 minutes | Standard Error 47.4 |
p-value: 0.777495% CI: [-19.4, 10.9]ANOVA