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CompletedNCT04114591Updated Oct 3, 2019

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

An observational study in Low Anterior Resection Syndrome, Cancer and Quality of Life, sponsored by University of Malta. Completed at 1 site in Malta. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by University of Malta · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
179
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Anterior Resection Syndrome
  • Cancer
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • colorectal cancer (>15cm) from anal verge
  • permanent stoma
  • known disseminated or recurrent disease,
  • patient without restitution of bowel continuity after 1 year
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
179 participants (actual)
Patient registry
No

Groups and cohorts

  • LARS symptoms

    Patient suffering from LARS as identified through LARS questionnaire

    Procedure: anterior resection

  • No LARS symptoms

    Absence of LARS symptoms

    Procedure: anterior resection

Interventions

  • Procedureanterior resection

    The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed

    Also known as: radiotherapy +/- chemotherapy

05

What researchers measure

Primary outcomes

  1. LARS incidence

    Incidence of LARS in patients who had anterior resection

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. Life

    The association between LARS and quality of life was assessed.

    Time frame: 1 year

06

Study locations

1 site
  • Mater Dei Hospital
    Valletta, Malta
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04114591
Lead sponsor
University of Malta
Responsible party
Svetlana Doris Brincat (Surgical trainee, University of Malta) — Principal investigator
First posted
Oct 3, 2019
Start date
Jul 1, 2018
Primary completion
Jan 30, 2019
Completion
Jan 30, 2019
Last update
Oct 3, 2019

Study contacts

Svetlana Doris Brincat
principal investigator · Mater Dei Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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