Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.

Eligibility criteria

Qualifiers

patients older than 18 years

patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy

able to give informed consent as documented by signature

Disqualifiers

dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects

impossibility of stoma reversal due to persistent anastomotic leak and/or local recurrence

Trial design

Treatments tested in this trial

  • Intensified follow-up program

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

St. Claraspital AG

Collaborator

Clarunis - Universitäres Bauchzentrum Basel

Collaborator