Anastomotic Leakage in Right Colectomy

NCT06553261 — Unknown, 3446 participants, Barmherzige Brüder Vienna

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Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study

Registry	NCT06553261
Status	Unknown
Study type	Observational
Enrollment	3446 (Estimated)
Sponsor	Barmherzige Brüder Vienna (Other); collaborators: Barmherzige Brüder Salzburg, Kepler University Hospital, University of Salzburg, Hospital Barmherzige Schwestern Vienna, Medical University of Vienna, University Hospital, Saarland, Sigmund Freud PrivatUniversitat
Conditions	Anastomotic Leak
Interventions	suturing of leak, lavage, drainage, Formation of a new anasthomosis, Fecal diversion (Procedure)
Dates	start 2024-08-12 (estimated), primary completion 2024-10-12 (estimated), completion 2024-12-12 (estimated), first posted 2024-08-14, last updated 2024-08-14
Locations	1 site in Austria

-Summary

Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients after laparoscopic right hemicolectomy		Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion	Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.
Patients after open right hemicolectomy		Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion	Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.

suturing of leak, lavage, drainage (Procedure): Operative suturing of the leak, lavage, drainage within a revision surgery.
Formation of a new anasthomosis (Procedure): Operative resection of the old leaking anastomosis and formation of a new one.
Fecal diversion (Procedure): Formation of a deviating stoma.

+Outcome measures

Primary outcomes

Clinical outcome [2010-2019]: Survival or death

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with benign or malignant diseases in the right portion of the colon.
* elective surgery

Exclusion Criteria:

* emergent surgery

+Locations (1)

Facility	City	Country	Status
Krankenhaus der Barmherzigen Brüder	Vienna	Austria	Recruiting

+Investigators

Bernhard Dauser, Assoc. Prof., Principal investigator, Krankenhaus der Barmherzigen Brüder Vienna