Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study

This study adds to the understanding of the contributing factors leading to LARS, the long term effects of this syndrome post-operatively and its impact on quality of life.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Low Anterior Resection Syndrome
• Intervention / Treatment: Procedure: anterior resection

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Malta
  • Valletta, Malta
    • Mater Dei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients >18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Description

Inclusion Criteria:

• All adult patients >18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Exclusion Criteria:

• colorectal cancer (>15cm) from anal verge
• permanent stoma
• known disseminated or recurrent disease,
• patient without restitution of bowel continuity after 1 year

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LARS symptoms; Patient suffering from LARS as identified through LARS questionnaire	Procedure: anterior resection; The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed; Other Names: radiotherapy +/- chemotherapy
No LARS symptoms; Absence of LARS symptoms	Procedure: anterior resection; The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed; Other Names: radiotherapy +/- chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS incidence	Incidence of LARS in patients who had anterior resection	1 year
Risk factors	Variable factors which might have contributed to LARS were the following: Age; Gender; Diabetes mellitus; Pathological stage; MRI stage; Distance from anal verge; Surgical technique; Preoperative radiotherapy; Preoperative chemotherapy; Postoperative radio/chemotherapy; Type of anastomosis; Presence of stoma; Interval from stoma reversal; Duration of follow-up	1 year
Life	The association between LARS and quality of life was assessed.	1 year

Collaborators and Investigators

• Sponsor: University of Malta
• Investigators: Principal Investigator: Svetlana Doris Brincat, Mater Dei Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: S07/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No