NCT01313026

Brief Summary

A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 7, 2018

Status Verified

June 1, 2018

Enrollment Period

7.1 years

First QC Date

January 7, 2011

Last Update Submit

December 6, 2018

Conditions

Rectal Cancer

Keywords

Percutaneous nerve evaluationTransanal irrigationLow anterior resection syndrome

Outcome Measures

Primary Outcomes (1)

  • changes in LARS score

    A symptom score ranging from 0 to 42 points calculated on the basis of bowel function

    baseline, 12, 16, 20, 24 and 28 weeks

Secondary Outcomes (4)

  • Sexual function

    baseline, 12, 16, 20, 24 and 28 weeks

  • Bladder function

    baseline, 12, 16, 20, 24 and 28 weeks

  • Incontinence

    baseline, 12, 16, 20, 24 and 28 weeks

  • Patient Satisfaction

    baseline, 12, 16, 20, 24 and 28 weeks

Study Arms (2)

PNE first

ACTIVE COMPARATOR

patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation

Procedure: Percutaneous nerve evaluation

TAI first

ACTIVE COMPARATOR

Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator

Procedure: Percutaneous nerve evaluation

Interventions

Percutaneous nerve evaluationPROCEDURE

Implantation of a nerve stimulator to stimulate the sacral nerve plexus

Also known as: The Peristeen Anal Irrigation System, Medtronic nerve stimulators
PNE firstTAI first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low anterior resection for rectal cancer between May 2001 and May 2011

You may not qualify if:

  • Non-radical resection
  • metastatic disease
  • Chemotherapy
  • Radiotherapy
  • Previously treated for another cancer
  • Dementia or other mental retardation/severe mental disease
  • Inability to read and understand the Danish language
  • Recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorectal Surgical Department P, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Rectal NeoplasmsLow Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katrine J. Emmertsen, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

March 11, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2018

Study Completion

September 1, 2018

Last Updated

December 7, 2018

Record last verified: 2018-06

Locations

DK(1)