Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection

Condition(s) studied

Investigational drug(s) / intervention(s)

Rectal resection: Open or minimally invasive rectal resection with total mesorectal excision

Study summary

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

Primary outcome measure(s)

• Assessment of pelvic function before and after rectal resection — 5 years
  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 — 5 years
  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 — 5 years
  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).

Trial sites (1)

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