NCT Number: NCT05257746
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Dresden, Saxony, 01307, Germany
Location status: Recruiting
Fiona Kolbinger, Dr.
SUB_INVESTIGATOR
Johannes Fritzmann, Dr.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Open or minimally invasive rectal resection with total mesorectal excision
Time frame: 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).
Time frame: 5 years
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Time frame: 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).
Time frame: during surgery
Time from skin incision until placement of last skin staple/suture.
Time frame: during surgery
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
Time frame: At day of discharge, assessed up to 90 days
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 90 days
Postoperative day 1 until day of discharge
Time frame: 90 days after surgery
Frequency of peri-operative complications after resection
Time frame: 90 days after surgery
Kind of peri-operative complications after resection
Contact information is provided by the study sponsor or research team.
Technische Universität Dresden
Other
Acronym: PERIFUNC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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