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

Recruiting

• Conditions: Rectal Surgery

• Registration Number: NCT05257746
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-02-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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 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).

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss [mL]	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
Operating time [min]	during surgery	Time from skin incision until placement of last skin staple/suture.
Duration of postoperative hospital stay [days]	At day of discharge, assessed up to 90 days	Postoperative day 1 until day of discharge
Kind of peri-operative morbidity after resection	90 days after surgery	Kind of peri-operative complications after resection
Duration of postoperative intermediate/intensive care unit stay [days]	At day of discharge, assessed up to 90 days	Postoperative day 1 until day of discharge
Frequency of peri-operative morbidity after resection	90 days after surgery	Frequency of peri-operative complications after resection

Trial Locations

Locations (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany