Crohn's Disease
Conditions
Brief summary
For patients with Crohn's diseases，whether prophylactic abdominal drainage is necessary need further exploration. the present study is focusing on the necessity of prophylactic abdominal drainage in CD patients after surgery.
Detailed description
In the past decades, surgical dogma meant the correct placement of a prophylactic drain, with the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation and avoiding potential postoperative ascites. However, recent randomized controlled trials (RCTs) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits on postoperative outcomes. Crohn's disease (CD), which is definitely different from CRC, is a chronic inflammatory disease with unknown pathogenesis. CD itself was the independent risk factor of multiple postoperative complications, including anastomotic leakage, intraperitoneal abscess and catheter-associated bloodstream infection. In the present RCT, we hypothesize that non-prophylactic peritoneal drainage is associated with increased incidence of postoperative non-septic complications.
Interventions
DEVICEprophylactic drainage
place prophylactic drainage after surgery
DEVICEno prophylactic drainage
Not place prophylactic drainage after surgery
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Investigators, surgical team and patients were not blinded to the assignment. In the the drain group, a 28 G latex tube was placed in the pelvic cavity intraoperatively and in the no-drain group, no drain was positioned. 30-day postoperative complications were assessed.
Intervention model description
A Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.
Exclusion criteria
* Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose \>126 mg/dL), as well as chronic systemic disease of cardiovascular, respiratory et al. * Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of prolonged postoperative ileus | postoperative 30 days | incidence of prolonged postoperative ileus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | postoperative 30 days and 1 year after surgery for endoscopic recurrence. | time to first passage of flatus and stool, pain relief, postoperative length of stay (LOS), postoperative complications (defined as Clavien-Dindo) within 30 days after surgery, incisional SSIs, readmission rates, medical costs,blood markers,endoscopic recurrence at the anastomosis. |
Countries
China
Outcome results
None listed