Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Rectal sphincter function before and after rectal resection
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing rectal resection with total mesorectal excision
Exclusion Criteria
- •primary or secondary removal of rectal sphincter apparatus
- •patients with enterostomy persisting 12 months after initial rectal resection
Outcomes
Primary Outcomes
Rectal sphincter function before and after rectal resection
Time Frame: 5 years
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Assessment of pelvic function before and after rectal resection
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).
Assessment of stool continence before and after rectal resection
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).
Secondary Outcomes
- Operating time [min](during surgery)
- Duration of postoperative hospital stay [days](At day of discharge, assessed up to 90 days)
- Kind of peri-operative morbidity after resection(90 days after surgery)
- Intraoperative blood loss [mL](during surgery)
- Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 90 days)
- Frequency of peri-operative morbidity after resection(90 days after surgery)