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Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer

Study on Clinical Application of Robotic Technique

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06409403
Enrollment
164
Registered
2024-05-10
Start date
2017-01-01
Completion date
2025-12-31
Last updated
2024-05-10

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

Conditions

Colorectal Cancer

Brief summary

Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.

Interventions

DEVICEclinical application of robotic technique

effect of various surgical technique on clinical efficacy of TME

Sponsors

general surgery 3
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

(i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3

Exclusion criteria

Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score \<10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.

Design outcomes

Primary

MeasureTime frameDescription
International Prostate Symptom Score (IPSS)preoperation,1、3、6、12 months after operationevaluation of genitourinary function

Secondary

MeasureTime frameDescription
Female Sexual Function Index (FSFI)preoperation,1、3、6、12 months after operationevaluation of genitourinary function
operative timeperioperativeoperative outcomes
blood looseperioperativeoperative outcomes
conversionperioperativeoperative outcomes
International Index of Erectile Function (IIEF)preoperation,1、3、6、12 months after operationevaluation of genitourinary function
complete TME specimensperioperativeoperative outcomes
circumferential resection margins (CRMs)perioperativeoperative outcomes
complicationperioperativeoperative outcomes
retrieved lymph nodesperioperativeoperative outcomes

Countries

China

Contacts

Primary ContactBo Yi, MD
yibo2018pro@126.com13786179533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026