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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011328
Enrollment
100
Registered
2016-11-23
Start date
2016-11-29
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C21.8

Interventions

Group 1: Retal resection, Robot-assisted: One 12 mm camera port, one 12 mm assistant port, four 8 mm ports for the robotic arms are placed at specifically defined localizations. First, small bowel wil

Sponsors

Chirurgische UniversitätsklinikKlinik für Allgemeine-, Viszerale- und Transplantationschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Functional outcome 6 and 12 months after surgery. Stool, urinary and sexual function as assessed by Wexner-score, EORTC QLQ-CR29 and EORTC QLQ-C30.

Secondary

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

Countries

Germany

Contacts

Public ContactYakup Kulu

Chirurgische Universitätsklinik HeidelbergKlinik für Allgemeine-, Viszerale- und Transplantationschirurgie

yakup.kulu@med.uni-heidelberg.de06221/566250

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026