Health Condition 1: K638- Other specified diseases of intestine Health Condition 2: K631- Perforation of intestine (nontraumatic)
Conditions
Interventions
Intervention1: Group ‘A’ Stapled alone: Involves creation of enterotomy one in the proximal part of the small intestine and another in the distal part of the healthy bowel followed by application of s
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age both male and female 2. Patients can follow instructions and are ready for regular follow up 3. Able to provide informed and written consent 4. Indications for resection and anastomosis a) Non-trauma elective and emergency cases with small intestine perforation or obstruction. b) Mesenteric ischemia or strangulation: Small Intestinal obstruction with segmental ischemia or gangrene c) Tumour: small bowel mass, Small bowel malignancy with adequate negative margin d) Inflammatory bowel disease (Crohn’s enteritis with complications) refractory to conservative treatment or stricture not amenable to stricturoplasty e) Entero-cutaneous fistula not amenable to closure or conservative treatment f) Symptomatic benign disease such as Meckles diverticulum or perforated diverticulitis or intussusception of bowel needing resection and anastomosis g) Incarcerated hernia h) Patients with ileostomy for closure
Exclusion criteria
Exclusion criteria: 1. Age 2. Pregnancy 3. Refusal to consent or participate in the study 4. Proximal diverting ostomy creation at the time of intestinal anastomosis 5. Over-sewing of anastomotic edge or anastomotic site omentoplasty was performed 6. Anastomosis involving oesophagus, stomach, duodenum, colon and rectum 7. Not amenable for resection and anastomosis surgery based on surgeons judgement: a) Anatomical difficulties in applying stapler b) Active Inflammatory bowel disease where stricturoplasty was considered c) Bowel with doubtful viability or questionable blood supply d) Inadequate tumour margin e) Patients on immunosuppressive drugs, post-chemotherapy or post-radiotherapy f) Hypotension (blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety: means the technical ability to provide air and water tight closure of anastomosis when procedure is performed by trained residents. • Efficacy: efficacy means the ability to prevent anastomotic failure. 1.Dehiscence / leak: verified by reoperation and visualization or radiologically contrast extravasation 2.Intra-abdominal abscess: identified by reoperation or radiologically present along with anastomotic dehiscence 3.Entero-cutaneous fistula Timepoint: Safety: Immediately after completion of anastomoses Efficacy: within 30 post-operative days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anastomotic time 2. Total Operative time 3. Intraoperative blood loss 4. Intraoperative blood transfusion (number of units: PRBC/FFP/Platelets) 5. Surgical site infection 6. Abdominal wall dehiscence 7. In-hospital mortality 8. Duration of postoperative hospital stay 9. Duration of postoperative ICU stay 10. Cost-effectivenessTimepoint: Anastomotic time: More than or equal to 1 minutes Total Operative time: More than or equal to 1 hours Intraoperative blood transfusion: More than or equal to 1 units Surgical site infection: Less than or equal to 30 days Abdominal wall dehiscence: Less than or equal to 30 days In-hospital mortality: Less than or equal to 30 days Duration of postoperative hospital stay: Less than or equal to 30 days Duration of postoperative ICU stay: Less than or equal to 30 days | — |
Countries
India
Contacts
Public ContactManjunath Maruti Pol
All India Institute of Medical Science Delhi
Outcome results
None listed