Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (\<120 days after discharge following intestinal bypass reconstruction) with sacral nerve root neuromodulation, compared with another group receiving personalized conservative treatment as performed in routine clinical practice.

Eligibility criteria

Qualifiers

Adult patients (18 years of age or older) who are capable of signing the appropriate informed consent form.

Patients who have undergone an anterior rectal resection for rectal cancer, with an anastomosis, whether or not they have received neoadjuvant therapy, and who have bowel function, either via a direct anastomosis or following reconstruction of a lateral ileostomy.

Patients who experience more than 6 episodes of urgency and/or incontinence in the following two weeks after the screening visit, as recorded in a daily bowel diary.

Patients with a LARS score >21 points (major or minor LARS).

Disqualifiers

Metastatic disease at the time of surgery.

Need for adjuvant chemotherapy at the time of assessment.

Active chemotherapy.

Patients with an ileostomy.

Trial design

Treatments tested in this trial

  • Sacral neuromodulation

Treatment groups

40 Participants
are divided into 2 treatment groups