Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
1 other identifier
observational
179
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedOctober 3, 2019
October 1, 2019
7 months
September 25, 2019
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
LARS symptoms
Patient suffering from LARS as identified through LARS questionnaire
No LARS symptoms
Absence of LARS symptoms
Interventions
The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- colorectal cancer (\>15cm) from anal verge
- permanent stoma
- known disseminated or recurrent disease,
- patient without restitution of bowel continuity after 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mater Dei Hospital
Valletta, Malta
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Svetlana Doris Brincat
Mater Dei Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgical trainee
Study Record Dates
First Submitted
September 25, 2019
First Posted
October 3, 2019
Study Start
July 1, 2018
Primary Completion
January 30, 2019
Study Completion
January 30, 2019
Last Updated
October 3, 2019
Record last verified: 2019-10