Efficiency of transanal irrigation and stimulation of a nerve of the ankle to improve symptoms and quality of life after radical surgery of rectal cancer

• Register: ISRCTN
• Last refreshed on: 29 October 2019
• Main ID: ISRCTN18237643
• Date of registration: 14/03/2017
• Prospective Registration: Yes
• Primary sponsor: Hospital Universitario Donostia
• Public title: Efficiency of transanal irrigation and stimulation of a nerve of the ankle to improve symptoms and quality of life after radical surgery of rectal cancer
• Scientific title: Transanal irrigation and percutaneous tibial nerve stimulation in the treatment of anterior resection syndrome after rectal cancer resection
• Date of first enrolment: 01/04/2017
• Target sample size: 28
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18237643
• Study type: Interventional
• Study design: Open categorized interventional parallel assignment 1:1 multicentre randomized clinical trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Spain

Contacts

• Name: Jose M Enriquez-Navascues

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients operated on for rectal cancer with sphincter preservation and functional anastomosis at least one year before study
2. Aged 20 to 80

Exclusion criteria:
1. IBD
2. IBS
3. Pregnancy
4. Other intestinal resection segments different from the rectum
5. Metastatic disease
6. Previous history of SNS or PTNS
7. Severe postflebitic syndrome
8. Pacemaker or defibrillator
9. Neurological disorders


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients operated for rectal cancer with sphincter preservation and poor postoperative intestinal function
Surgery

Intervention(s)

The randomization sequence will be performed by a computerized randomization algorithm integrated in the program (R v2.9). Patients are randomized to:
1. Transanal irrigation (TAI) with a device (Peristeen, Coloplast DK). Transanal irrigation is performed using the Peristeen system. This consists of a bag that is filled with up to 1000 cc of lukewarm tap water, a coated rectal catheter with a retaining balloon which is inserted in the neorectum, a control unit for the regulation of air and water and a pump for inflating the balloon and for irrigating the rectum. Patients are instructed by a trained stoma nurse for 3-4 weeks; once the patient is familiar with the procedure, he or she can do it independently at home. Test scores are recorded at baseline, 12, 18 and 24 weeks.
2. Posterior tibial nerve stimulation (PTNS) (Urgent PC, Uroplasty, Nl). PTNS consists of the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface is placed under the arch of the foot. Both electrodes are connected to the neurostimuator that generates electricity. A neuromodulation session last 30 minutes. The treatment plan includes 12 weekly sessions, followed by two sessions at two weeks’ intervals. Test scores are recorded at baseline, 12, 18 and 24 weeks.

Primary Outcome(s)

Severity of LARS, measured using the Low Anterior Resection Syndrome scale (LARS) at baseline, 12, 18 and 24 weeks

Secondary Outcome(s)

Measured at baseline, 12, 18 and 24 weeks:
1. Fecal incontinence, measured using Vaizey’s score
2. Dysfunctional defecation, measured using Altomare’s score
3. Quality of life, measured using the QLQ-C30 Score
4. Patient satisfaction, measured using the VAS

Secondary ID(s)

JME-DON-2017-03

Source(s) of Monetary Support

Hospital Universitario Donostia

Ethics review

Status:
Approval date:
Contact:

Hospital Donostia Ethics Committee, 21/03/2017

Results

• Results available: Yes
• Date Completed: 01/04/2018