Health Condition 1: K940- Colostomy complications
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Basavatarakam Indo American Cancer Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects aged above 18 years 2.The Subject must be treated with staplers or suture. 3.Subjects who will undergo an anastomotic procedure throughout the colon and rectal. 4.The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form. 5.If the Subject is not able to understand fill out the informed consent form on behalf of the Subject, the Subjects LAR will fill in the informed consent form. 6.The Subject is willing and able to comply with postoperative scheduled clinical evaluations. 7. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Exclusion criteria
Exclusion criteria: 1.Subject aged below 18 years. 2.Pregnant women must be excluded from the study 3.Subject having any previous anal surgery. 4.Subject with any other anal pathology like fissure, anal stenosis, rectal prolapse, etc. 5.Subject with anti-coagulant treatment. 6.Subjects with complications such as intestinal perforation and peritonitis and instability of vital signs must be excluded. 7.The Subject with intestinal chronic inflammatory disease must be excluded. 8.The Subject is not eligible for the study without informed consent. 9.Tissues that can be compressed to less than 1 mm in thickness are not suitable for the application of the staplers, as inadequate staple tightness may compromise hemostasis. 10.Tissues that cannot be comfortably compressed to 2.5 mm in thickness are ineligible for the application of the staplers. 11.The use of the staplers is not recommended for the Subject, where visual verification of hemostasis adequacy cannot be confirmed after firing. 12.The staplers should not be utilized for stapling tissues presenting features such as necrosis, friability, or compromised integrity, such as features such as necrosis, friability, or compromised integrity, such as ischemic or edematous conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Completion time for anastomosis 2.Technical success 3.Intra-operative complications/Adverse event/ SAETimepoint: 1.Time Frame: Intraoperative 2.Time Frame: Intraoperative, 7 days 2 days, 30 days 5 days, 3 months 7 days, 6 months 15 days 3. Time Frame: Intra-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Stapling misfunction rate 2.Imaging / radiographic imaging 3.Device-related early complications [ 4.Re-operation 5.Adverse Events 6.Evaluation of Quality of Life 7.Length of hospital stayTimepoint: 1.Time Frame: Intra-operative 2.Time Frame: postoperative, 7 days 2 days, 30 days 5 days, 3 months 7 days, 6 months 15 days, or prior to death, whichever came first 3.Time Frame: 7 days 2 days, 30 days 5 days 4.Time Frame: 7 days 2 days, 30 days 5 days, 3 months 7 days, 6 months 15 days, or prior to death, whichever came first 5.Time Frame: 7 days 2 days, 30 days 5 days, 3 months 7 days, 6 months 15 days, or prior to death, whichever came first 6.Time Frame: Baseline, 7 days 2 days, 30 days 5 days, 3 months 7 days, 6 months 15 days, and or prior to death, whichever came first 7.Time Frame: From Admission to discharge | — |
Countries
India
Contacts
Public ContactDr Srijan Shukla
Basavatarakam Indo American Cancer Hospital
Outcome results
None listed