Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114591
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Svetlana Doris Brincat, 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.

Condition or disease Intervention/treatment
Low Anterior Resection Syndrome Cancer Quality of Life Procedure: anterior resection

Layout table for study information
Study Type : Observational
Actual Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

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 Name: 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 Name: radiotherapy +/- chemotherapy




Primary Outcome Measures :
  1. LARS incidence [ Time Frame: 1 year ]
    Incidence of LARS in patients who had anterior resection

  2. Risk factors [ Time Frame: 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

  3. Life [ Time Frame: 1 year ]
    The association between LARS and quality of life was assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114591


Locations
Layout table for location information
Malta
Mater Dei Hospital
Valletta, Malta
Sponsors and Collaborators
University of Malta
Investigators
Layout table for investigator information
Principal Investigator: Svetlana Doris Brincat Mater Dei Hospital

Layout table for additonal information
Responsible Party: Svetlana Doris Brincat, Surgical trainee, University of Malta
ClinicalTrials.gov Identifier: NCT04114591    
Other Study ID Numbers: S07/18
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Disease
Pathologic Processes