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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114591
• Other study ID #: S07/18
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: October 2019
• Source: University of Malta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• anterior resection
The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed

Locations

Country	Name	City	State
Malta	Mater Dei Hospital	Valletta

Sponsors (1)

Lead Sponsor	Collaborator
University of Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LARS incidence	Incidence of LARS in patients who had anterior resection	1 year
Primary	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
Primary	Life	The association between LARS and quality of life was assessed.	1 year