Robot-assisted surgery to improve functional results following sphincter-preserving rectal cancer resection.

Phase 1

Recruiting

• Conditions: C21.8; Overlapping lesion of rectum, anus and anal canal

• Registration Number: DRKS00011328
• Lead Sponsor: Chirurgische UniversitätsklinikKlinik für Allgemeine-, Viszerale- und Transplantationschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with a rectal cancer, scheduled for sphincter-preservation rectal cancer surgery in the
University Hospital Heidelberg.
2. Able to give written informed consent.
3. BMI<=30kg/m2
4. No medical contraindications that exclude laparoscopy.
5. Preoperatively normal stool/sexual/bladder functioning.

Exclusion Criteria

1. Preoperatively evident stool/sexual/bladder dysfunction.
2. Technical inoperable.
3. Lacking capacity to consent.
4. Locally advanced Tumor with infiltration of pelvic nerves.
5. BMI>30kg/m2
6. Medical contraindications that prohibit laparoscopy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome 6 and 12 months after surgery. Stool, urinary and sexual function as assessed by Wexner-score, EORTC<br>QLQ-CR29 and EORTC QLQ-C30.

Secondary Outcome Measures

Name	Time	Method
1. Completness of resection (R-Status, CRM).<br>2. Time from surgery to Hospital discharge.<br>3. Proportion and time to uptake of adjuvant Treatment.<br>4. Overall and disease-free survival after 1 year.