Anastomotic Bleeding in Colorectal Anastomosis Relating t... | NCT07506005

Studies
Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line

NCT07506005

Sponsor

Kepler University Hospital

Status

Recruiting

Last Update Posted

Apr 1, 2026Actual

Enrollment

102Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Diverticulitis

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2024Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Feb 23, 2026

First Submission Date that Met QC Criteria

Mar 29, 2026

First Posted Date

Apr 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2026

Last Update Posted Date

Apr 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

The aim of this study is to assess the incidence of anastomotic bleeding in double-stapled anastomoses in relation to the position of the trocar relative to the rectal staple line (on the mesenteric side of the rectal staple line versus opposite the mesenteric side).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenteric		Spike comes out on the side of the mesenterium according to to linear staple line
Antimesenteric		Spike comes out not on the side of the mesentery according to to linear staple line

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative intraluminal anastomotic bleeding	Intraoperative intraluminal bleeding of the stapling line	during surgery until getting the patient is out of the OR

Secondary Outcomes

Measure	Description	Time Frame
Postoperative bleeding	Postoperative intraluminal anastomotic bleeding	Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing colonic surgery (leaving the mesentery - TME ist excluded) and receiving primary anastomosis. Benign and maligne indication.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandra Raab, Dr.	Contact	+43 (0)5 7680 83 - 2133		sandra.raab@kepleruniklinikum.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler Universit Hospital, Surgical Department	Recruiting	Linz		4020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D004238	Diverticulitis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided