Tiger: 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

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00888849
• Collaborator: (none)
• Enrollment: 280
• Locations: 3
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 93.3
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

This study is being conducted to compare surgical and patient outcomes across stapled (Group

1. versus hand-sutured (Group I) groups.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Disease; Colorectal Disease	Procedure: Advant 55 Linear Cutter/Stapler; Procedure: Suturing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stapling	Procedure: Advant 55 Linear Cutter/Stapler; Advant 55 Linear Cutter/Stapler
Active Comparator: Suturing 4 layered hand-sutured anastomosis	Procedure: Suturing; Suturing

Outcome Measures

Primary Outcome Measures

1. Time of Surgery (Skin Open to Skin Close) [Day 1]

2. Time of Anastomosis [Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)]

3. Return to Bowel Activity [Number of days post-surgery to appearance of peristaltic movement]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Govt General Hospital and Madras Medical College	Chennai		India	600003
2	Indira Gandhi Government Medical College	Nagpur		India	440018
3	GB Pant Hospital	New Delhi		India	110002

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie AE. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004320. Review. Update in: Cochrane Database Syst Rev. 2011;(9):CD004320.

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT00888849
• Other Study ID Numbers: CI-07-0008
• First Posted: Apr 28, 2009
• Last Update Posted: Dec 5, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Ethicon Endo-Surgery: Stapling; hand sutured anastamosis; colorectal disease
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases

Study Results

Participant Flow

Arm/Group Title	Stapling	Suturing
Arm/Group Description	4 layered hand-sutured anastomosis
Period Title: Overall Study
STARTED	142	138
COMPLETED	137	129
NOT COMPLETED	5	9

Baseline Characteristics

Arm/Group Title	Stapling	Suturing	Total
Arm/Group Description	4 layered hand-sutured anastomosis	Total of all reporting groups
Overall Participants	142	138	280
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	124 87.3%	128 92.8%	252 90%
>=65 years	18 12.7%	10 7.2%	28 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (13.81)	43.7 (15.87)	43.8 (14.86)
Sex: Female, Male (Count of Participants)
Female	64 45.1%	56 40.6%	120 42.9%
Male	78 54.9%	82 59.4%	160 57.1%
Region of Enrollment (participants) [Number]
India	142 100%	138 100%	280 100%

Outcome Measures

1. Primary Outcome

Title	Time of Surgery (Skin Open to Skin Close)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Suturing	Stapling
Arm/Group Description	Hand-sutured anastomosis	Stapled Anastomosis
Measure Participants	138	142
Mean (Standard Error) [minutes]	168.4 (47.40)	172.7 (47.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Suturing, Stapling
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7774
	Comments	Adjusted for multiplicity via the Bonferroni-Holm method
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.3
	Confidence Interval	(2-Sided) 95%; -19.4 to 10.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.69
	Estimation Comments

2. Primary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suturing	Stapling
Arm/Group Description	Hand-sutured anastomosis	Stapled Anastomosis
Measure Participants	138	142
Mean (Standard Error) [minutes]	20.6 (1.90)	17.6 (1.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Suturing, Stapling
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments	Adjusted for multiplicity via Bonferroni-Holm procedure
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 1.4 to 4.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.80
	Estimation Comments

3. Primary Outcome

Title	Return to Bowel Activity
Time Frame	Number of days post-surgery to appearance of peristaltic movement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suturing	Stapling
Arm/Group Description	Hand-sutured anastomosis	Stapled Anastomosis
Measure Participants	138	142
Mean (Standard Error) [days]	4.2 (0.71)	4.0 (0.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Suturing, Stapling
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7774
	Comments	Adjusted for multiplicity via Bonferroni-Holm procedure
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments

Adverse Events

Arm/Group Title	Stapling		Suturing
Arm/Group Description	4 layered hand-sutured anastomosis
All Cause Mortality
	Stapling		Suturing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stapling		Suturing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/142 (6.3%)		8/138 (5.8%)
Blood and lymphatic system disorders
Bone marrow failure	3/142 (2.1%)	3	2/138 (1.4%)	2
Cardiac disorders
Acute myocardial infarction	1/142 (0.7%)	1	1/138 (0.7%)	1
Intestinal obstruction	1/142 (0.7%)	1	0/138 (0%)	0
Infections and infestations
Sepsis	0/142 (0%)	0	1/138 (0.7%)	1
Wound sepsis	0/142 (0%)	0	1/138 (0.7%)	1
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/142 (0.7%)	1	1/138 (0.7%)	1
Anastomotic fistula	1/142 (0.7%)	1	0/138 (0%)	0
Anastomotic leak	0/142 (0%)	0	1/138 (0.7%)	1
Failure to anastomose	0/142 (0%)	0	1/138 (0.7%)	1
Post procedural hemorrhage	0/142 (0%)	0	1/138 (0.7%)	1
Metabolism and nutrition disorders
Metabolic acidosis	1/142 (0.7%)	1	0/138 (0%)	0
Nervous system disorders
Hemiplegia	1/142 (0.7%)	1	0/138 (0%)	0
Postictal paralysis	1/142 (0.7%)	1	0/138 (0%)	0
Renal and urinary disorders
Azotaemia	1/142 (0.7%)	1	0/138 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/142 (0%)	0	1/138 (0.7%)	1
Acute respiratory failure	0/142 (0%)	0	1/138 (0.7%)	1
Pneumothorax	1/142 (0.7%)	1	0/138 (0%)	0
Pulmonary embolism	1/142 (0.7%)	1	1/138 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Stapling		Suturing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/142 (18.3%)		21/138 (15.2%)
General disorders
Pyrexia	3/142 (2.1%)	3	6/138 (4.3%)	6
Infections and infestations
Wound infection	19/142 (13.4%)	19	11/138 (8%)	11
Injury, poisoning and procedural complications
Wound secretion	6/142 (4.2%)	6	4/138 (2.9%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.