An interventional study of prophylactic drainage and no prophylactic drainage in Crohn's Disease, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Prevention
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.
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.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 100 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Jinling Hospital, China is the lead sponsor of 130 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Place prophylactic drainage after surgery.
Device: prophylactic drainage
Not place prophylactic drainage after surgery.
Device: no prophylactic drainage
place prophylactic drainage after surgery
Not place prophylactic drainage after surgery
incidence of prolonged postoperative ileus
incidence of prolonged postoperative ileus
Time frame: postoperative 30 days
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.
Time frame: postoperative 30 days and 1 year after surgery for endoscopic recurrence.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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