emergency/urgency operated gastrointestinal conditions prophylactic mesh retrorectus mesh incisional hernia
Conditions
Interventions
Light-
weight polypropylene mesh will be placed in retrorectus plane to augment fascia closure,closure will be performed with small tissue bites,
continuous monofilament suture
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
retrorectus mesh augmentation,primary suture closure
Sponsors
Vajira Hospital, Navamindradhiraj University
Ramathibodi hospital,
Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults age ≥ 18 years 2. Surgery within 24 hours after admission or consultation with suspected GI pathology 3. Receipt of midline abdominal incision with an incision length of at least 1/4 of the distance from the xiphoid process to the pubic symphysis 4. Have an American Society of Anesthesiologist (ASA) physical status class 1-4
Exclusion criteria
Exclusion criteria: 1. Any of following conditions: 1.1. Septic shock (hemodynamic instability) 1.2. Metastatic cancer (stage IV) at before or during operation 1.3. Dirty surgical wound with severe contamination from fecal material and frank pus (surgical wound class IV) 1.4. Massive devitalized bowel ischemia 2. potential second-look operation or planned revisionary surgery via a midline incision 3. secondary fascial closure 4. existence of midline incisional hernia and/or history of midline incisional hernia repair 5. pregnancy or plan for pregnancy after surgery 6. connective tissue disorders 7. current or planned immunosuppressive use 8. allergy to polypropylene
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incisional hernia at 3, 6, 12, 18, and 24 months detected by clinical examination and/or radiologic study | — |
Secondary
| Measure | Time frame |
|---|---|
| surgical site infection at 1, 3, 6, and 12 months superficial and deep surgical site infection according to CDC criteria,burst abdomen at 1 months fascial wound defect combined with internal organ evisceration,Seroma at 1 and 3 months fluid collection in the area of incision or serous leakage through the wound,hematoma at 1 week a collection of a blood clot which needed evacuation,enterocutaneous fistula/ chronic wound sinus at 1, 3, 6, and 12 months abnormal opening at incision producing discharge with/without connecting to GI tract,acute postoperative pain day 1 and 3 pain score (from 0 to 10),chronic pain at 3, 6, 12, 18 and 24 months pain in any degree, persisting at the incisional scar,length of hospital stay at the beginning of the study a number of days spent on admission after the index operation,abdominal wall closure time at the beginning of the study time spend from the starting of abdominal wall closure to completing of skin approximation,mesh removal rate at 1, 3, 6, 12, 18, and 24 months removal from any reason ,cost at the beginning of study, 1, 3, 6, 12, 18, and 24 months All cost data, including direct medical, direct non-medical, and indirect costs, will be retrieved i | — |
Countries
Thailand
Contacts
Public ContactAmarit Tansawet
Navamindradhiraj University
Outcome results
None listed