Health Condition 1: K251- Acute gastric ulcer with perforation Health Condition 2: K252- Acute gastric ulcer with both hemorrhage and perforation Health Condition 3: K255- Chronic or unspecified gastric ulcer with perforation Health Condition 4: K256- Chronic or unspecified gastric ulcer with both hemorrhage and perforation Health Condition 5: K261- Acute duodenal ulcer with perforation Health Condition 6: K262- Acute duodenal ulcer with both hemorrhage and perforation Health Condition 7: K265-
Conditions
Interventions
Intervention1: RTL Closure: Midline will be closed with the running suture loop PDS II (Ethicon), one from cranial end and another from caudal end at the distance of 5 mm with of fascia bilaterally 5
Sponsors
Dr Ravi Gupta
Eligibility
Inclusion criteria
Inclusion criteria: Patients who need to undergo a high risk primary midline laparotomy, age 18 years or more who will complete 1 year s follow-up will be included. Patients included in high risk laparotomy cases will be those who need to undergo an emergency major abdominal operation OR elective major abdominal operation for malignant or inflammatory intra-abdominal diseases OR they had at least one of the following risk factors for postoperative wound failure coexisting respiratory disease, intraabdominal infection, long-term use of steroids (more than 3 months), obesity, malnutrition, chemotherapy, diabetes, renal insufficiency
Exclusion criteria
Exclusion criteria: Pregnant female, patients with serious psychiatric disorder and lack of compliance, poor control of septic source and poor intraperitoneal lavage before closure of abdomen, unable to follow-up 1 year, not giving consent. Patients who undergo re-laparotomy within 30 days of index surgery or died, patients who have had previous abdominal surgery will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed. Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect.Timepoint: Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed. Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect. | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical site infection will be defined by using CDC guideline within 30 days of index surgeryTimepoint: 3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks;Wound complication will be defined by using Southampton Scoring Systems within the 30 days of index surgery.Timepoint: 3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks;Post operative pain will be assessed with VAS (visual analogue scale) on day 1, 3, 7 ,14.Timepoint: post-operative day 1,3,7 and 14;Postoperative complication will be assessed with Clavien Dindo classificationTimepoint: 3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks | — |
Countries
India
Contacts
Public ContactDr Ravi Gupta
All India Institute of Medical Sciences Gorakhpur
Outcome results
None listed