NCT07506005

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2024Dec 2028

Study Start

First participant enrolled

December 18, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 23, 2026

Last Update Submit

March 29, 2026

Conditions

Colorectal CancerDiverticulitis

Keywords

Colorectal anastomosisDouble StaplingAnastomotic Bleeding

Outcome Measures

Primary Outcomes (1)

  • Intraoperative intraluminal anastomotic bleeding

    Intraoperative intraluminal bleeding of the stapling line

    during surgery until getting the patient is out of the OR

Secondary Outcomes (1)

  • Postoperative bleeding

    Postoperative

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • TME

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler Universit Hospital, Surgical Department

Linz, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsDiverticulitis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritis

Central Study Contacts

Sandra Raab, Dr.

CONTACT

+43 (0)5 7680 83 - 2133sandra.raab@kepleruniklinikum.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

April 1, 2026

Study Start

December 18, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

AU(1)