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NCT03215017 Clinical Trial

Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

Low Anterior Resection Syndrome Clinical Trial

Official title:
A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03215017
Other study ID # 2017/551-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date December 1, 2022

Study information
Verified date March 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

Description:

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome. An interim analysis will be made after 40 included patients in the study.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection) - Adult = 18 years old - Have scoring major LARS (according to the Low anterior resection syndrome score) Exclusion Criteria: - stoma - recurrent disease - Another colorectal surgery - Inflammatory bowel disease (IBD)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transanal irrigation
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
Drug:
• Medication
Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)

Locations
Country Name City State
Sweden Danderyd Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Stockholm South General Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Mirna Abraham-Nordling

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M. A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Bowel function Cleveland incontinence questionnaire 1 year
Primary Bowel function, Low anterior resection syndrome (LARS) Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function) 1 year
Secondary Quality of Life (QoL) Assessed using EORTC Quality of life questionnaire (QLQ)-C30 1 year
See also
  Status Clinical Trial Phase
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Recruiting NCT04040842 - International Low Anterior Resection Score Evaluation
Recruiting NCT04023448 - The Effect of Different Reconstruction Methods on Anterior Resection Syndrome N/A
Recruiting NCT03828318 - Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial N/A
Completed NCT05605600 - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
Completed NCT05016583 - Paula Method of Exercises in Patients With LARS Syndrome N/A
Active, not recruiting NCT05042700 - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome Phase 2
Recruiting NCT04612569 - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed NCT04896879 - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Recruiting NCT06162143 - Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
Withdrawn NCT03257332 - Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Completed NCT03916549 - Acupuncture in Low Anterior Resection Syndrome Treatment Phase 1
Completed NCT05020132 - Bowel Dysfunction After Rectal Cancer Treatment
Completed NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome N/A
Recruiting NCT05420870 - Effect of Exercise on Bowel Function in Colorectal Cancer Survivors N/A
Active, not recruiting NCT05319054 - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A
Completed NCT06059170 - Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life N/A