Gastrointestinal DiseaseTigerNCT00888849

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

A study testing Advant 55 Linear Cutter/Stapler and Suturing in people with Gastrointestinal Disease and Colorectal Disease, run by Ethicon Endo-Surgery at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastrointestinal Disease, Colorectal Disease
What is being tested?: Advant 55 Linear Cutter/Stapler and Suturing
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 3 sitesIndia
Study dates: Apr 2009to Feb 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

3 sites in 1 country.

India3 sites

Govt General Hospital and Madras Medical College
Chennai, 600003
Indira Gandhi Government Medical College
Nagpur, 440018
GB Pant Hospital
New Delhi, 110002

Other trials in India

About this study

This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.

Conditions: Gastrointestinal Disease, Colorectal Disease
Being tested: Advant 55 Linear Cutter/Stapler, Suturing
Keywords: Stapling, hand sutured anastamosis, colorectal disease
Medical subject headings: Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Advant 55 Linear Cutter/StaplerProcedure or surgery
Advant 55 Linear Cutter/Stapler
SuturingProcedure or surgery
Suturing

Study groups in NCT00888849
Study group	Role	What they receive
Stapling	Experimental	Not described Receives: Procedure: Advant 55 Linear Cutter/Stapler
Suturing	Active comparator	4 layered hand-sutured anastomosis Receives: Procedure: Suturing

What is being measured

The primary outcome is the main question the study is designed to answer.

Time of Surgery (Skin Open to Skin Close)
Measured: Day 1
Time of Anastomosis
Measured: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
Return to Bowel Activity
Measured: Number of days post-surgery to appearance of peristaltic movement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Feb 2011

First posted28 Apr 2009 (estimated)
Study startApr 2009
Primary completionOct 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00888849
Sponsor's protocol ID: CI-07-0008
Acronym: Tiger
Status last verified: Nov 2011
First submitted: 20 Apr 2009
Last updated: 5 Dec 2011
Results posted: Yes, on ClinicalTrials.gov

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. doi: 10.1002/14651858.CD004320.pub2.
PubMed 17636751

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00888849
Acronym / sponsor ID: Tiger / CI-07-0008
Conditions: Gastrointestinal Disease, Colorectal Disease
Keywords: Stapling, hand sutured anastamosis, colorectal disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Oct 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 28 Apr 2009 (estimated)
Results: Posted 24 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stapling	Experimental	Procedure: Advant 55 Linear Cutter/Stapler
Suturing	Active comparator	Procedure: Suturing4 layered hand-sutured anastomosis

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advant 55 Linear Cutter/StaplerAdvant 55 Linear Cutter/Stapler	Procedure or surgery	Stapling
SuturingSuturing	Procedure or surgery	Suturing

Primary outcome

Time of Surgery (Skin Open to Skin Close)
Time frame: Day 1
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)
Return to Bowel Activity
Time frame: Number of days post-surgery to appearance of peristaltic movement

Results and safety

Results posted to the registry on 24 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stapling	142	137
Suturing	138	129

Primary outcome: Time of Surgery (Skin Open to Skin Close)

Time frame: Day 1. Mean (Standard Error). Unit: minutes

Measure	Suturing n = 138	Stapling n = 142
Value	168.4 (47.40)	172.7 (47.40)

Suturing vs Stapling: Mean Difference (Final Values): -4.3 (95% CI -19.4 to 10.9), p = 0.7774, ANOVA

Population analysed: Intent-to-Treat

Primary outcome: 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). Mean (Standard Error). Unit: minutes

Measure	Suturing n = 138	Stapling n = 142
Value	20.6 (1.90)	17.6 (1.90)

Suturing vs Stapling: Mean Difference (Final Values): 2.9 (95% CI 1.4 to 4.5), p = 0.0008, ANOVA

Primary outcome: Return to Bowel Activity

Time frame: Number of days post-surgery to appearance of peristaltic movement. Mean (Standard Error). Unit: days

Measure	Suturing n = 138	Stapling n = 142
Value	4.2 (0.71)	4.0 (0.71)

Suturing vs Stapling: Mean Difference (Final Values): 0.2 (95% CI -0.2 to 0.6), p = 0.7774, ANOVA

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stapling	9 of 142 (6.3%)	26 of 142 (18.3%)	Not reported
Suturing	8 of 138 (5.8%)	21 of 138 (15.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17636751Choy 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. doi: 10.1002/14651858.CD004320.pub2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Advant 55 Linear Cutter/Stapler and Suturing in people with Gastrointestinal Disease and Colorectal Disease, run by Ethicon Endo-Surgery at 3 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of Surgery (Skin Open to Skin Close) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00888849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.