Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKepler University Hospital
About this trial
Each colorectal anastomosis is routinely evaluated intraoperatively by sigmoidoscopy and, in the presence of signs of bleeding, also postoperatively (persistent rectal bleeding within 24 hours after surgery).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Colorectal surgery with primary colorectal anastomosis using the double-stapling technique, including side-to-end or end-to-end anastomosis
Documented anastomotic orientation (mesenteric vs. antimesenteric)
Disqualifiers
TME
Trial population
Patients undergoing colonic surgery (leaving the mesentery - TME ist excluded) and receiving primary anastomosis. Benign and maligne indication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
102 Participants
are grouped into 2 trial groupsGroup A: Mesenteric
Group B: Antimesenteric
Trial outcomes
Primary outcomes
1
Intraoperative intraluminal anastomotic bleeding
Intraoperative intraluminal bleeding of the stapling line
Time frame
during surgery until getting the patient is out of the ORSecondary outcomes
1
Postoperative bleeding
Postoperative intraluminal anastomotic bleeding
Time frame
PostoperativeSponsors and contacts
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Source ClinicalTrials.gov