Anastomotic Leakage in Right Colectomy

NCT06553261 | Recruiting

• 1 other identifier: LEAK1
• Study Type: observational
• Target: 3,446
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Clinical outcome

  Survival or death

  2010-2019

Study Arms (2)

Patients after laparoscopic right hemicolectomy

Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.

Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion

Patients after open right hemicolectomy

Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.

Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion

Interventions

suturing of leak, lavage, drainage PROCEDURE

Operative suturing of the leak, lavage, drainage within a revision surgery.

Patients after laparoscopic right hemicolectomy; Patients after open right hemicolectomy

Formation of a new anasthomosis PROCEDURE

Operative resection of the old leaking anastomosis and formation of a new one.

Patients after laparoscopic right hemicolectomy; Patients after open right hemicolectomy

Fecal diversion PROCEDURE

Formation of a deviating stoma.

Patients after laparoscopic right hemicolectomy; Patients after open right hemicolectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with benign or malignant diseases in the right colon.

You may qualify if:

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

You may not qualify if:

• emergent surgery

Sponsors & Collaborators

• Barmherzige Brüder Vienna: lead
• Barmherzige Brüder Salzburg: collaborator
• Kepler University Hospital: collaborator
• University of Salzburg: collaborator
• Hospital Barmherzige Schwestern Vienna: collaborator
• Medical University of Vienna: collaborator
• University Hospital, Saarland: collaborator
• Sigmund Freud PrivatUniversitat: collaborator

Study Sites (1)

Krankenhaus der Barmherzigen Brüder

Vienna, 1020, Austria

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Therapeutic Irrigation; Drainage

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Surgical Procedures, Operative

Study Officials

• Bernhard Dauser, Assoc. Prof.

  Krankenhaus der Barmherzigen Brüder Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Dauser, Assoc. Prof.

CONTACT

0043 1 211210; bernhard.dauser@gmail.com

ILIYAN ILIEV, MD

CONTACT

0043 6607435277; iliyaniliev18s@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: August 12, 2024
• Primary Completion: October 12, 2024
• Study Completion: December 12, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

AU (1)