The EVICEL® Gastrointestinal Study
Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01589822
Collaborator
(none)
214
22
3
27
9.7
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
Study Design
Study Type:
Interventional
Actual Enrollment
:
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
Study Start Date
:
Jun 1, 2012
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EVICEL Fibrin Sealant: Randomized EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. |
Biological: EVICEL Fibrin Sealant
Intraoperative
Other Names:
|
| No Intervention: Standard of Care Standard surgical technique for GI anastomosis. |
|
| Experimental: Experimental: EVICEL Fibrin Sealant: Non-Randomized EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen |
Biological: EVICEL Fibrin Sealant
Intraoperative
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Absence of Gastrointestinal (GI) Leak [40 days]
Secondary Outcome Measures
- Incidence of Adverse Events [up to Day 90]
- Incidence of GI Leak [90 days]
- Incidence of Stricture [up to Day 90]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects undergoing primary elective GI surgery
-
Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
Exclusion Criteria:
-
Avastin use within 30 days prior to surgery;
-
Known hypersensitivity to the human blood products or the components of the investigational product;
-
Female subjects who are pregnant or nursing;
-
Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Investigation Site #1 | Irvine | California | United States | 92868 |
| 2 | Clinical Investigation Site #2 | Jacksonville | Florida | United States | 32099 |
| 3 | Clinical Investigation Site #5 | Augusta | Georgia | United States | 30912 |
| 4 | Clinical Investigation Site #4 | New Orleans | Louisiana | United States | 70121 |
| 5 | Clinical Investigation Site #8 | Portland | Oregon | United States | 97239 |
| 6 | Clinical Investigation Site #23 | Greenville | South Carolina | United States | 29605 |
| 7 | Clinical Investigation Site #3 | Houston | Texas | United States | 77030 |
| 8 | Clinical Investigation Site #6 | Houston | Texas | United States | 77030 |
| 9 | Clinical Investigation Site #19 | New Lambton | New South Wales | Australia | 2305 |
| 10 | Clinical Investigation Site #18 | South Adelaide | Australia | 6010 | |
| 11 | Clinical Investigation Site #17 | Genk | Belgium | 3600 | |
| 12 | Clinical Investigation Site #16 | Ghent | Belgium | 9000 | |
| 13 | Clinical Investigation Site #10 | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 14 | Clinical Investigation Site #9 | Toronto | Ontario | Canada | M5G 1X5 |
| 15 | Clinical Investigation Site #22 | Seoul | Korea, Republic of | 138-736 | |
| 16 | Clinical Investigation Site #21 | Seoul | Korea, Republic of | ||
| 17 | Clinical Investigation Site #20 | Auckland | New Zealand | 0622 | |
| 18 | Clinical Investigation Site #15 | Edinburgh | United Kingdom | EH42XU | |
| 19 | Clinical Investigation Site #11 | Leicester | United Kingdom | LE15WW | |
| 20 | Clinical Investigation Site #12 | Nottingham | United Kingdom | NG72UH | |
| 21 | Clinical Investigation Site #13 | Plymouth | United Kingdom | PL68DH | |
| 22 | Clinical Investigation Site #14 | Sheffield | United Kingdom | S57AU |
Sponsors and Collaborators
- Ethicon, Inc.
Investigators
- Study Director: Richard Kocharian, MD, Ethicon, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01589822
Other Study ID Numbers:
- 400-11-002
First Posted:
May 2, 2012
Last Update Posted:
Feb 25, 2015
Last Verified:
Feb 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized |
|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative | Standard surgical technique for GI anastomosis. | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative |
| Period Title: Overall Study | |||
| STARTED | 84 | 89 | 41 |
| COMPLETED | 80 | 86 | 40 |
| NOT COMPLETED | 4 | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | Total |
|---|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative | Standard surgical technique for GI anastomosis. | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative | Total of all reporting groups |
| Overall Participants | 84 | 89 | 41 | 214 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
61.1
(11.1)
|
62.5
(10.8)
|
62.0
(12.2)
|
61.8
(11.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
41
48.8%
|
33
37.1%
|
21
51.2%
|
95
44.4%
|
| Male |
43
51.2%
|
56
62.9%
|
20
48.8%
|
119
55.6%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
21
25%
|
21
23.6%
|
8
19.5%
|
50
23.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
2.4%
|
1
0.5%
|
| White |
61
72.6%
|
65
73%
|
31
75.6%
|
157
73.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
2.4%
|
3
3.4%
|
1
2.4%
|
6
2.8%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
15
17.9%
|
17
19.1%
|
13
31.7%
|
45
21%
|
| Canada |
2
2.4%
|
2
2.2%
|
4
9.8%
|
8
3.7%
|
| Belgium |
17
20.2%
|
17
19.1%
|
3
7.3%
|
37
17.3%
|
| Australia |
10
11.9%
|
9
10.1%
|
6
14.6%
|
25
11.7%
|
| New Zealand |
10
11.9%
|
10
11.2%
|
1
2.4%
|
21
9.8%
|
| United Kingdom |
10
11.9%
|
14
15.7%
|
7
17.1%
|
31
14.5%
|
| Korea, Republic of |
20
23.8%
|
20
22.5%
|
7
17.1%
|
47
22%
|
Outcome Measures
| Title | Absence of Gastrointestinal (GI) Leak |
|---|---|
| Description | |
| Time Frame | 40 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized |
|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (IIT) | Standard surgical technique for GI anastomosis. (IIT) | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative (Safety Set) |
| Measure Participants | 84 | 89 | 41 |
| Number [participants] |
72
85.7%
|
81
91%
|
38
92.7%
|
| Title | Incidence of Adverse Events |
|---|---|
| Description | |
| Time Frame | up to Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized |
|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set) | Standard surgical technique for GI anastomosis. (Safety Set) | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative (Safety Set) |
| Measure Participants | 84 | 89 | 41 |
| Number [number of adverse events] |
633
|
735
|
347
|
| Title | Incidence of GI Leak |
|---|---|
| Description | |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks. |
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized |
|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set) | Standard surgical technique for GI anastomosis. (Safety Set) | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative (Safety Set) |
| Measure Participants | 84 | 89 | 41 |
| Number [participants] |
9
10.7%
|
6
6.7%
|
3
7.3%
|
| Title | Incidence of Stricture |
|---|---|
| Description | |
| Time Frame | up to Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized |
|---|---|---|---|
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set) | Standard surgical technique for GI anastomosis. (Safety Set) | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative (Safety Set) |
| Measure Participants | 84 | 89 | 41 |
| Number [participants] |
2
2.4%
|
3
3.4%
|
1
2.4%
|
Adverse Events
| Time Frame | AEs occurring up to study Day-90 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | |||
| Arm/Group Description | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set) | Standard surgical technique for GI anastomosis. (Safety Set) | EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen EVICEL Fibrin Sealant: Intraoperative (Safety Set) | |||
All Cause Mortality |
||||||
| EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/84 (29.8%) | 22/89 (24.7%) | 10/41 (24.4%) | |||
| Cardiac disorders | ||||||
| ACUTE MYOCARDIAL INFARCTION | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| ANGINA UNSTABLE | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| ATRIOVENTRICULAR BLOCK COMPLETE | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| CARDIAC ARREST | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| Gastrointestinal disorders | ||||||
| ABDOMINAL PAIN | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| COLITIS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| CONSTIPATION | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| DIARRHOEA | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| ENTEROCUTANEOUS FISTULA | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| ILEUS | 3/84 (3.6%) | 2/89 (2.2%) | 0/41 (0%) | |||
| ILEUS PARALYTIC | 1/84 (1.2%) | 1/89 (1.1%) | 0/41 (0%) | |||
| INTESTINAL OBSTRUCTION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| INTESTINAL PERFORATION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| RECTAL HAEMORRHAGE | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| SMALL INTESTINAL OBSTRUCTION | 0/84 (0%) | 2/89 (2.2%) | 0/41 (0%) | |||
| SMALL INTESTINAL PERFORATION | 0/84 (0%) | 1/89 (1.1%) | 1/41 (2.4%) | |||
| General disorders | ||||||
| CHEST PAIN | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| PYREXIA | 2/84 (2.4%) | 0/89 (0%) | 0/41 (0%) | |||
| Hepatobiliary disorders | ||||||
| PORTAL VEIN THROMBOSIS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Infections and infestations | ||||||
| ABDOMINAL INFECTION | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| ABDOMINAL SEPSIS | 2/84 (2.4%) | 2/89 (2.2%) | 1/41 (2.4%) | |||
| ABSCESS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| CELLULITIS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| ENDOCARDITIS | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| GASTROENTERITIS | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| HAEMATOMA INFECTION | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| INFECTIOUS PERITONITIS | 2/84 (2.4%) | 0/89 (0%) | 0/41 (0%) | |||
| LIVER ABSCESS | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| NECROTISING FASCIITIS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| PELVIC ABSCESS | 2/84 (2.4%) | 2/89 (2.2%) | 0/41 (0%) | |||
| PERITONITIS | 2/84 (2.4%) | 3/89 (3.4%) | 0/41 (0%) | |||
| PYELONEPHRITIS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| PYELONEPHRITIS ACUTE | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| URINARY TRACT INFECTION | 0/84 (0%) | 3/89 (3.4%) | 0/41 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| ANASTOMOTIC HAEMORRHAGE | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| ANASTOMOTIC LEAK | 9/84 (10.7%) | 6/89 (6.7%) | 3/41 (7.3%) | |||
| ANASTOMOTIC STENOSIS | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| INTESTINAL ANASTOMOSIS COMPLICATION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| POSTOPERATIVE ILEUS | 0/84 (0%) | 3/89 (3.4%) | 0/41 (0%) | |||
| WOUND COMPLICATION | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| WOUND DEHISCENCE | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| WOUND EVISCERATION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Investigations | ||||||
| BLOOD MAGNESIUM DECREASED | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| DEHYDRATION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| BREAST CANCER | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| URETHRAL CANCER | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Nervous system disorders | ||||||
| CRITICAL ILLNESS POLYNEUROPATHY | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Psychiatric disorders | ||||||
| CONFUSIONAL STATE | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| DEPRESSION | 1/84 (1.2%) | 0/89 (0%) | 1/41 (2.4%) | |||
| Renal and urinary disorders | ||||||
| RENAL FAILURE ACUTE | 1/84 (1.2%) | 1/89 (1.1%) | 0/41 (0%) | |||
| URETERIC STENOSIS | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| URETHRAL STENOSIS | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| Reproductive system and breast disorders | ||||||
| BENIGN PROSTATIC HYPERPLASIA | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| PELVIC HAEMATOMA | 0/84 (0%) | 0/89 (0%) | 1/41 (2.4%) | |||
| BRONCHIAL SECRETION RETENTION | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| HICCUPS | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| PLEURAL EFFUSION | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| RESPIRATORY ARREST | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
| RESPIRATORY FAILURE | 1/84 (1.2%) | 1/89 (1.1%) | 0/41 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| RASH MACULO-PAPULAR | 1/84 (1.2%) | 0/89 (0%) | 0/41 (0%) | |||
| Surgical and medical procedures | ||||||
| ABSCESS DRAINAGE | 0/84 (0%) | 1/89 (1.1%) | 0/41 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 81/84 (96.4%) | 83/89 (93.3%) | 41/41 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 3/84 (3.6%) | 5/89 (5.6%) | 4/41 (9.8%) | |||
| Cardiac disorders | ||||||
| TACHYCARDIA | 6/84 (7.1%) | 12/89 (13.5%) | 4/41 (9.8%) | |||
| ILEUS | 6/84 (7.1%) | 5/89 (5.6%) | 1/41 (2.4%) | |||
| Gastrointestinal disorders | ||||||
| ABDOMINAL DISTENSION | 12/84 (14.3%) | 17/89 (19.1%) | 5/41 (12.2%) | |||
| ABDOMINAL PAIN | 17/84 (20.2%) | 17/89 (19.1%) | 8/41 (19.5%) | |||
| CONSTIPATION | 14/84 (16.7%) | 17/89 (19.1%) | 11/41 (26.8%) | |||
| DIARRHOEA | 11/84 (13.1%) | 15/89 (16.9%) | 8/41 (19.5%) | |||
| NAUSEA | 42/84 (50%) | 47/89 (52.8%) | 22/41 (53.7%) | |||
| PROCTALGIA | 3/84 (3.6%) | 5/89 (5.6%) | 1/41 (2.4%) | |||
| RECTAL HAEMORRHAGE | 3/84 (3.6%) | 5/89 (5.6%) | 4/41 (9.8%) | |||
| VOMITING | 20/84 (23.8%) | 22/89 (24.7%) | 11/41 (26.8%) | |||
| General disorders | ||||||
| FATIGUE | 7/84 (8.3%) | 3/89 (3.4%) | 4/41 (9.8%) | |||
| PAIN | 5/84 (6%) | 10/89 (11.2%) | 5/41 (12.2%) | |||
| PYREXIA | 15/84 (17.9%) | 17/89 (19.1%) | 9/41 (22%) | |||
| Infections and infestations | ||||||
| URINARY TRACT INFECTION | 5/84 (6%) | 11/89 (12.4%) | 1/41 (2.4%) | |||
| WOUND INFECTION | 2/84 (2.4%) | 5/89 (5.6%) | 4/41 (9.8%) | |||
| Injury, poisoning and procedural complications | ||||||
| ANASTOMOTIC LEAK | 9/84 (10.7%) | 6/89 (6.7%) | 3/41 (7.3%) | |||
| INCISION SITE PAIN | 3/84 (3.6%) | 3/89 (3.4%) | 6/41 (14.6%) | |||
| PROCEDURAL PAINii | 19/84 (22.6%) | 17/89 (19.1%) | 6/41 (14.6%) | |||
| WOUND COMPLICATION | 5/84 (6%) | 2/89 (2.2%) | 0/41 (0%) | |||
| Investigations | ||||||
| C-REACTIVE PROTEIN INCREASED | 4/84 (4.8%) | 6/89 (6.7%) | 0/41 (0%) | |||
| OXYGEN SATURATION DECREASED | 6/84 (7.1%) | 1/89 (1.1%) | 1/41 (2.4%) | |||
| URINE OUTPUT DECREASED | 7/84 (8.3%) | 10/89 (11.2%) | 2/41 (4.9%) | |||
| WHITE BLOOD CELL COUNT INCREASED | 5/84 (6%) | 2/89 (2.2%) | 1/41 (2.4%) | |||
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 8/84 (9.5%) | 6/89 (6.7%) | 2/41 (4.9%) | |||
| HYPOKALAEMIA | 5/84 (6%) | 9/89 (10.1%) | 5/41 (12.2%) | |||
| Nervous system disorders | ||||||
| DIZZINESS | 5/84 (6%) | 9/89 (10.1%) | 4/41 (9.8%) | |||
| PERIPHERAL SENSORY NEUROPATHY | 3/84 (3.6%) | 5/89 (5.6%) | 2/41 (4.9%) | |||
| Psychiatric disorders | ||||||
| ANXIETY | 5/84 (6%) | 3/89 (3.4%) | 2/41 (4.9%) | |||
| INSOMNIA | 7/84 (8.3%) | 7/89 (7.9%) | 6/41 (14.6%) | |||
| Renal and urinary disorders | ||||||
| DYSURIA | 3/84 (3.6%) | 5/89 (5.6%) | 2/41 (4.9%) | |||
| URINARY RETENTION | 3/84 (3.6%) | 5/89 (5.6%) | 0/41 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 5/84 (6%) | 3/89 (3.4%) | 1/41 (2.4%) | |||
| PLEURAL EFFUSION | 1/84 (1.2%) | 5/89 (5.6%) | 2/41 (4.9%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| PRURITUS | 9/84 (10.7%) | 8/89 (9%) | 6/41 (14.6%) | |||
| Vascular disorders | ||||||
| HYPERTENSION | 4/84 (4.8%) | 9/89 (10.1%) | 3/41 (7.3%) | |||
| HYPOTENSION | 13/84 (15.5%) | 16/89 (18%) | 5/41 (12.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Director of Clinical Development |
|---|---|
| Organization | Ethicon |
| Phone | 1 908 218-2492 |
| JBatill2@its.jnj.com |
Responsible Party:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01589822
Other Study ID Numbers:
- 400-11-002
First Posted:
May 2, 2012
Last Update Posted:
Feb 25, 2015
Last Verified:
Feb 1, 2015