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.

Phase 4

Completed

• Registration Number: CTRI/2009/091/000311
• Lead Sponsor: Johnson and Johnson Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of surgery <br/ ><br>Time of anastomosis <br/ ><br>Return to bowel activity movement <br/ ><br>Timepoint: The trial will consist of the following visits: <br/ ><br>?Visit 1 ? Screening <br/ ><br>?Visit 2 ? Surgery <br/ ><br>?Visit 3 ? Immediate Post-surgical period until day of suture removal <br/ ><br>?Visit 4 ? Final Visit (approximately Day 25 post surgery) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Days to be fit for resuming normal life<br>Total anesthesia time<br>Return to normal diet<br>Frequency of post-surgical leak confirmed by medical or radiological examination<br>Admission to Intensive Care Unit (ICU) due to post surgical complications related to anastomotic procedure<br>Length of stay in ICU<br>Intra-operative resource utilization: OR, Staff, anesthesia, Medications and medical supplies<br>ICU resource utilization: staff, medications, medical interventions, diagnostic tests, and medical supplies.<br>Post-operative ward stay resource utilization: staff, medications, medical interventions, diagnostic tests, and medical supplies<br>Number of follow-up visits<br> Days to be fit for medical/surgical discharge<br> Days to discharge<br>Timepoint: The trial will consist of the following visits:<br>?Visit 1 ? Screening<br>?Visit 2 ? Surgery<br>?Visit 3 ? Immediate Post-surgical period until day of suture removal<br>?Visit 4 ? Final Visit (approximately Day 25 post surgery)<br>