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

Completed

• Conditions: Cancer; Low Anterior Resection Syndrome; Quality of Life
• Interventions: Procedure: anterior resection

• Registration Number: NCT04114591
• Lead Sponsor: University of Malta

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Study First Submitted: 2019-09-25
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-03
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No LARS symptoms	anterior resection	Absence of LARS symptoms
LARS symptoms	anterior resection	Patient suffering from LARS as identified through LARS questionnaire

Primary Outcome Measures

Name	Time	Method
LARS incidence	1 year	Incidence of LARS in patients who had anterior resection
Life	1 year	The association between LARS and quality of life was assessed.
Risk factors	1 year	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

Trial Locations

Locations (1)

Mater Dei Hospital; 🇲🇹 Valletta, Malta