| CTRI Number |
CTRI/2009/091/000311 [Registered on: 15/06/2009] |
| Last Modified On: |
29/09/2014 |
| Post Graduate Thesis |
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| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to see the effect of stapled anastamosis and Hand sutured anastamosis in patients undergoing gastrointestinal end to end and side to side anastamosis. |
Scientific Title of Study
Modification(s)
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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 |
| Trial Acronym |
|
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CI-07-0008 |
Protocol Number |
| NCT00888849 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Kulwant S Saini |
| Designation |
|
| Affiliation |
Johnson and Johnson Ltd |
| Address |
4th Floor, Building No. 9B, Cyber City, DLF Phase III, Gurgaon-122002 (Haryana), INDIA
Gurgaon
HARYANA
122002
India |
| Phone |
+91 124 4285854 or 4781720 |
| Fax |
+91 124 4285855 |
| Email |
KSAINI @its.jnj.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Charlotte Rodrigues |
| Designation |
Manager Corporate Communication |
| Affiliation |
|
| Address |
Johnson and Johnson Ltd. 30,Forjett Street,Mumbai-400036
Mumbai
MAHARASHTRA
400036
India |
| Phone |
02266646464 |
| Fax |
|
| Email |
CRodrig8@ITS.JNJ.COM |
|
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Source of Monetary or Material Support
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Primary Sponsor
Modification(s)
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| Name |
Johnson and Johnson Ltd |
| Address |
Johnson & Johnson Ltd
501 Arena Space, Off Jogeshwari – Vikroli Link Road (JVLR),
Behind Majas Bus Depot, Jogeshwari (East), Mumbai - 400060
|
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Anil Agarwal |
Department of GI Surgery,G.B.Pant Hospital |
G. B. Pant Hospital, J. L. Nehru Marg,-110 002
New Delhi
DELHI |
011 -23235702 / 23234242
aka.gis@gmail.com |
| Dr. Raj Gajbhiye |
Department of Surgery, Indira Gandhi Government Medical College |
Department of Surgery, Indira Gandhi Government Medical College, Nagpur - 440018,-440018
Nagpur
MAHARASHTRA |
9422101440
rajgajbhiye@hotmail.com |
| Dr.Chandramohan |
Government General Hospital |
Surgical Gastroenterology,,-600003
Chennai
TAMIL NADU |
09841031888
smchandra@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethical Commitee of Indiara Gandhi Government Medical College,Institutional Ethics Commitee,Department of Medicine,IGGMC,Central Avenue Road,Nagpur-440018. |
Approved |
| Govt.General hospital & madras medical college |
Approved |
| Maulana azad medical college and associated Lok Nayak,govind ballabh pant hospital,guru nanak eye centre, New delhi-110002 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Adults (18-75 years of age) undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand sutured anastamosis |
|
| Intervention |
stapled anastamosis |
|
|
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Inclusion Criteria
|
| Age From |
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| Age To |
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| Gender |
|
| Details |
a. Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document;
b. 18 years to 75 years (inclusive);
c. Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis;
d. Willing to adhere to standard postoperative care, including ventilator support if required;
e. Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilizilation, with appropriate documentation);
f. 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; and
g. 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.
|
|
| ExclusionCriteria |
| Details |
a. Women of childbearing potential who are pregnant at the time of screening or at the time of surgery;
b. 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;
c. Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of > 3mg/dL;
d. Subject has liver failure as evidenced by CP category C;
e. 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;
f. Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment;
g. Any subject that the investigator determines is not likely to be compliant during the study period;
h. 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;
i. 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; and
j. Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
Time of surgery
Time of anastomosis
Return to bowel activity movement
|
The trial will consist of the following visits:
? Visit 1 ? Screening
? Visit 2 ? Surgery
? Visit 3 ? Immediate Post-surgical period until day of suture removal
? Visit 4 ? Final Visit (approximately Day 25 post surgery)
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Secondary Outcome
|
| Outcome |
TimePoints |
| Days to be fit for resuming normal life
Total anesthesia time
Return to normal diet
Frequency of post-surgical leak confirmed by medical or radiological examination
Admission to Intensive Care Unit (ICU) due to post surgical complications related to anastomotic procedure
Length of stay in ICU
Intra-operative resource utilization: OR, Staff, anesthesia, Medications and medical supplies
ICU resource utilization: staff, medications, medical interventions, diagnostic tests, and medical supplies.
Post-operative ward stay resource utilization: staff, medications, medical interventions, diagnostic tests, and medical supplies
Number of follow-up visits
Days to be fit for medical/surgical discharge
Days to discharge
|
The trial will consist of the following visits:
? Visit 1 ? Screening
? Visit 2 ? Surgery
? Visit 3 ? Immediate Post-surgical period until day of suture removal
? Visit 4 ? Final Visit (approximately Day 25 post surgery)
|
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Target Sample Size
|
Total Sample Size="300"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
07/04/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
In process |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
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This will be a prospective, randomized, interventional, parallel, controlled trial to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups. At least 300 patients, male and female, admitted on emergency or elective admissions will be enrolled in the study. Subjects enrolled in the study will be randomly assigned to one of two treatment groups i.e Group I - Hand Sutured and Group II - Stapled. |