A Phase 2/3 interventional study of Interrupted sutures and Continuous sutures in Laparotomy and Hernia, sponsored by Heidelberg University. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-27.
Sponsored by Heidelberg University · Phase 2/3, Interventional, and Treatment
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 80 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preoperative Inclusion criteria:
Intraoperative inclusion criteria before closure:
Exclusion Criteria:
Preoperative exclusion criteria:
Intraoperative exclusion criteria before closure:
Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
Procedure: Interrupted sutures
Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)
Procedure: Continuous sutures
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
Incisional hernia or burst abdomen within 12 months
Time frame: 12 months
Quality of Life
Time frame: 12 months
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Heidelberg University