Risk Factors Associated With Anastomotic Leak and Perioperative Mortality in Elderly

Risk Factors Associated With Anastomotic Leak and Perioperative Mortality in Elderly Patients Undergoing Colorectal Surgery.

This is a retrospective cohort study of all consecutive patients who underwent colon or rectal resection, between the years 2012-2017 at Rabin Medical Center, a tertiary referral center in Israel. Data were obtained from patients' electronic medical files. The study was approved by the Institutional Review Board (IRB) of Rabin Medical Center (RMC). The study met the guidelines outlined in the Declaration of Helsinki. Due to the minimal risk nature of this study, the need for informed consent was waived by the IRB.

Patient population:

All patients aged 70 years and above who underwent large bowel resection were included in the analysis. Inclusion criteria were: age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach Exclusion criteria were: age<70; colon resection without anastomoses; re-operations during the same admission .

Data retrieved included demographic data (age, gender, Charlson comorbidity score, place of residency, functional capacity, BMI), surgical data (indication for surgery, elective vs urgent surgery, surgical approach, length of surgery, peri-operative morbidity and mortality.All surgeries were performed by at least one senior surgeon. The surgical approach (laparoscopic or laparotomy) was at the senior surgeon's discretion and deemed most appropriate for the patient's problem, physiological status and underlying illnesses. The extent of the resection was according to oncological guidelines when relevant

Endpoints:

Primary endpoint was the occurrence of postoperative anastomotic leak. Secondary end-point was postoperative mortality Statistical Analysis The statistical analysis for this paper was generated using SAS Software. Continuous variables were presented by Mean±Std, Categorical variables were presented by (N, %). T-Test was used to compare the value of continuous variables between study groups and Fisher's exact test (for two groups) or Chi-square (for more than two groups) were used to compare the value of categorical variables between study groups. Two-sided p values less than .05 were considered statistically significant

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak
• Intervention / Treatment: Procedure: colon or rectum resection

Detailed Description

This is a retrospective cohort study of all consecutive patients who underwent colon or rectal resection, between the years 2012-2017 at Rabin Medical Center, a tertiary referral center in Israel. Data were obtained from patients' electronic medical files. The study was approved by the Institutional Review Board (IRB) of Rabin Medical Center (RMC). The study met the guidelines outlined in the Declaration of Helsinki. Due to the minimal risk nature of this study, the need for informed consent was waived by the IRB.

Patient population:

All patients aged 70 years and above who underwent large bowel resection were included in the analysis. Inclusion criteria were: age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach Exclusion criteria were: age<70; colon resection without anastomoses; re-operations during the same admission .

Data retrieved included demographic data (age, gender, Charlson comorbidity score, place of residency, functional capacity, BMI), surgical data (indication for surgery, elective vs urgent surgery, surgical approach, length of surgery, peri-operative morbidity and mortality.All surgeries were performed by at least one senior surgeon. The surgical approach (laparoscopic or laparotomy) was at the senior surgeon's discretion and deemed most appropriate for the patient's problem, physiological status and underlying illnesses. The extent of the resection was according to oncological guidelines when relevant.

Endpoints:

Primary endpoint was the occurrence of postoperative anastomotic leak. Secondary end-point was postoperative mortality Statistical Analysis The statistical analysis for this paper was generated using SAS Software. Continuous variables were presented by Mean±Std, Categorical variables were presented by (N, %). T-Test was used to compare the value of continuous variables between study groups and Fisher's exact test (for two groups) or Chi-square (for more than two groups) were used to compare the value of categorical variables between study groups. Two-sided p values less than .05 were considered statistically significant

• Study Type: Observational
• Enrollment (Actual): 536

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach

Description

Inclusion Criteria:

age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach -

Exclusion Criteria:

- age<70; colon resection without anastomoses; re-operations during the same admission .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
anastamotic leak	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	untill 8.2020

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: ilan schrier, MD, TAU

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2017
• Primary Completion (ACTUAL): May 19, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (ACTUAL): August 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: 0441-17-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No