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

Rectal Surgery Clinical Trial

— PERIFUNC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257746
• Other study ID #: VTG-10
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: June 30, 2030

Study information

• Verified date: June 2024
• Source: Technische Universität Dresden
• Contact: Johannes Fritzmann, Dr.
• Phone: +49 351 458 19477
• Email: johannes.fritzmann[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Surgery

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	5 years
Primary	Rectal sphincter function before and after rectal resection	Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively	5 years
Primary	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).	5 years
Secondary	Operating time [min]	Time from skin incision until placement of last skin staple/suture.	during surgery
Secondary	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	during surgery
Secondary	Duration of postoperative hospital stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 90 days
Secondary	Duration of postoperative intermediate/intensive care unit stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 90 days
Secondary	Frequency of peri-operative morbidity after resection	Frequency of peri-operative complications after resection	90 days after surgery
Secondary	Kind of peri-operative morbidity after resection	Kind of peri-operative complications after resection	90 days after surgery