Colorectal Anastomotic Leak Management

NCT05000580 | Completed

• 1 other identifier: CALM-V3
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal anastomotic leaks (AL) are associated with high morbidity and mortality. Management of AL and its intra-operative decision making is often difficult. The aim of this multi-centre study is to explore different management strategies, including different surgical options, and analyse rates and patterns of failure of initial management. All consecutive patients who had a confirmed AL after elective colorectal resections from 1st January 2014 to 31st December 2019 were included at seven hospitals across the East of England Region. Morbidity (length of stay, and failures) and mortality were compared across the different management strategies, and survival analyses were performed.

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• failure rate of initial management strategy

  failure rate of initial management strategy

  5 years

Secondary Outcomes (2)

• mortality

  5 years

• length of stay

  5 years

Interventions

Surgical PROCEDURE

Conservative vs surgical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients can be identified and recruited to the study through a variety of ways: * Multi-Disciplinary Teams (MDTs): Most MDTs will record data as to who has had a leak and what treatment they have had or are to have * Colorectal Clinical Nurse Specialists (CNS): In most trusts, the CNS keep records of patients who have had complications * National Bowel Cancer Audit (NBOCAP): Although this will not capture patients who have had benign disease, it will provide data on patients with cancer * Consultants: Many consultants collect their own data, and this can be an excellent source of information

You may qualify if:

• Age ≥18 years old
• Patients undergoing colorectal anastomosis for any pathology (benign or malignant), during an elective or emergency admission, who had an AL.
• Laparoscopic or open surgery

You may not qualify if:

• IBD, Small bowel anastomosis,

Sponsors & Collaborators

• Surgical Trainees East of England Research Collaborative: lead

Study Sites (1)

Watford General Hospital

Watford, WD18 0HB, United Kingdom

Location

Related Publications (1)

• Aker M, Askari A, Rabie M, Aly M, Adegbola S, Patel K, Currow C, Nunn R, Hadjittofi C, Rankin A, Halai S, Elsamani K, Bondje S, Mohamed I, Lee J, Wong J, Robertson-Waters E, Uddin A, Hollingshead J. Management of anastomotic leaks after elective colorectal resections: The East of England experience. A retrospective cohort. Int J Surg. 2021 Dec;96:106167. doi: 10.1016/j.ijsu.2021.106167. Epub 2021 Nov 6.

  PMID: 34752951 DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Medhat Aker, FRCS

  Registrar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR, Prinicipal investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 11, 2021
• Study Start: January 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)