Trial Outcomes & Findings for An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses (NCT NCT00888849)
NCT ID: NCT00888849
Last Updated: 2011-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
Day 1
Results posted on
2011-12-05
Participant Flow
Participant milestones
| Measure |
Stapling
|
Suturing
4 layered hand-sutured anastomosis
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
138
|
|
Overall Study
COMPLETED
|
137
|
129
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
Stapling
|
Suturing
4 layered hand-sutured anastomosis
|
|---|---|---|
|
Overall Study
Death
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
Baseline characteristics by cohort
| Measure |
Stapling
n=142 Participants
|
Suturing
n=138 Participants
4 layered hand-sutured anastomosis
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
124 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age Continuous
|
43.8 years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 15.87 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 14.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
142 participants
n=5 Participants
|
138 participants
n=7 Participants
|
280 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Intent-to-Treat
Outcome measures
| Measure |
Suturing
n=138 Participants
Hand-sutured anastomosis
|
Stapling
n=142 Participants
Stapled Anastomosis
|
|---|---|---|
|
Time of Surgery (Skin Open to Skin Close)
|
168.4 minutes
Standard Error 47.40
|
172.7 minutes
Standard Error 47.40
|
PRIMARY outcome
Timeframe: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)Outcome measures
| Measure |
Suturing
n=138 Participants
Hand-sutured anastomosis
|
Stapling
n=142 Participants
Stapled Anastomosis
|
|---|---|---|
|
Time of Anastomosis
|
20.6 minutes
Standard Error 1.90
|
17.6 minutes
Standard Error 1.90
|
PRIMARY outcome
Timeframe: Number of days post-surgery to appearance of peristaltic movementOutcome measures
| Measure |
Suturing
n=138 Participants
Hand-sutured anastomosis
|
Stapling
n=142 Participants
Stapled Anastomosis
|
|---|---|---|
|
Return to Bowel Activity
|
4.2 days
Standard Error 0.71
|
4.0 days
Standard Error 0.71
|
Adverse Events
Stapling
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Suturing
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stapling
n=142 participants at risk
|
Suturing
n=138 participants at risk
4 layered hand-sutured anastomosis
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.1%
3/142 • Number of events 3
|
1.4%
2/138 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.70%
1/142 • Number of events 1
|
0.72%
1/138 • Number of events 1
|
|
Cardiac disorders
Intestinal obstruction
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Infections and infestations
Sepsis
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.70%
1/142 • Number of events 1
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Nervous system disorders
Hemiplegia
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Nervous system disorders
Postictal paralysis
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Renal and urinary disorders
Azotaemia
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/142
|
0.72%
1/138 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.70%
1/142 • Number of events 1
|
0.00%
0/138
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.70%
1/142 • Number of events 1
|
0.72%
1/138 • Number of events 1
|
Other adverse events
| Measure |
Stapling
n=142 participants at risk
|
Suturing
n=138 participants at risk
4 layered hand-sutured anastomosis
|
|---|---|---|
|
Infections and infestations
Wound infection
|
13.4%
19/142 • Number of events 19
|
8.0%
11/138 • Number of events 11
|
|
General disorders
Pyrexia
|
2.1%
3/142 • Number of events 3
|
4.3%
6/138 • Number of events 6
|
|
Injury, poisoning and procedural complications
Wound secretion
|
4.2%
6/142 • Number of events 6
|
2.9%
4/138 • Number of events 4
|
Additional Information
Sheryl Helsinger/Clinical Affairs Director
Ethicon Endo Surgery, Inc
Phone: 513-337-3079
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER