Health Condition 1: K639- Disease of intestine, unspecified
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 – 70 Years 2. Both gender 3. Post-operative abdominal surgery undergone intestinal anastomosis 4. Patients can follow instructions and are ready for regular follow up 5. Able to provide informed and written consent 6. Non-trauma elective and emergency cases with small intestine perforation or obstruction. 7. Mesenteric ischemia or strangulation: Small Intestinal obstruction with segmental ischemia or gangrene 8. Tumour: small bowel mass , Small bowel malignancy with adequate negative margin 9. Entero-cutaneous fistula 10. Symptomatic benign disease such as Meckles diverticulum or perforated diverticulitis or intussusception of bowel needing resection and anastomosis 11. Incarcerated hernia 12. Patients with ileostomy for closure
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years and more than 70 years 2. Patients taking immunosuppressive therapy and chemotherapy. 3. Patients with known hematological disorders or malignancy. 4. Patients with known chronic liver or kidney disease 5. Auto-immune disease or immunodeficiency syndrome 6. Pregnant or lactating mother 7. Refusal to consent or participate in the study 8. Proximal diverting ostomy creation at the time of intestinal anastomosis 9. Patients receiving Albumin Supplementation during the period of the study. 10. Abdominal trauma with small intestine perforation or obstruction. 11. Active inflammatory bowel disease (Crohn’s enteritis with complications) 12. Anastomosis involving oesophagus, stomach, duodenum, colon and rectum 13. Patients on immunosuppressive drugs, post-chemotherapy or post-radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy of drain fluid biomarkers in predicting anastomotic leakTimepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of ICU & hospital stay 2. Post-operative morbidity: Clavien- Dindo classification 3. Post-op complications: SSI, IA abscess, obstruction, Burst abdomen, AKI, LRTI, ARDS, DVT 4. Post-operative re-intervention 5. Quality of life 6. Cost-analysis 7. Mortality Timepoint: 1. Days 2. Clavien Dindo classification 3. Yes or No 4. Days 5. questionnaire 6. In rupees 7. Yes or No | — |
Countries
India
Contacts
Public ContactDr Sweta Bhartiya
All India Institute of Medical Sciences New Delhi
Outcome results
None listed