About this trial
The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing rectal resection with total mesorectal excision
Disqualifiers
primary or secondary removal of rectal sphincter apparatus
patients with enterostomy persisting 12 months after initial rectal resection
Trial population
All patients undergoing rectal resection with total mesorectal excision
Trial design
Cohort
Prospective
Treatments tested in this trial
Rectal resection
Procedure/SurgeryOpen or minimally invasive rectal resection with total mesorectal excision
Treatment groups
Trial outcomes
Primary outcomes
Assessment of pelvic function before and after rectal resection
Rectal and urogenital function will be assessed preoperatively and 12-24 months and 5 years postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Assessment of stool continence before and after rectal resection
Stool continence will be assessed preoperatively and 12-24 months and 5 years postoperatively using the LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse stool continence).
Secondary outcomes
Operating time [min]
Time from skin incision until placement of last skin staple/suture.
Intraoperative blood loss [mL]
Intraoperative blood loss presents the amount of blood lost from skin incision until skin closure. Spilling water and ascites will be subtracted. Swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Sponsors and contacts
Click on the lead sponsor to view all of their trials.