An observational study in Rectal Surgery, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Technische Universität Dresden · Observational
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.
Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
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All patients undergoing rectal resection with total mesorectal excision
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Exclusion Criteria:
Open or minimally invasive rectal resection with total mesorectal excision
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).
Time frame: 5 years
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Time frame: 5 years
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).
Time frame: 5 years
Operating time [min]
Time from skin incision until placement of last skin staple/suture.
Time frame: during surgery
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
Time frame: during surgery
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 90 days
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 90 days
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after resection
Time frame: 90 days after surgery
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after resection
Time frame: 90 days after surgery
Plan to share: No — Following publication of study results, de-identified patient data will be made available upon reasonable request
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Jun 2030, 111 months after the start.
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