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

general surgery 3

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Device: clinical application of robotic technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06409403

YB2017

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 3 patient groups

da Vinci robotic TME

Experimental group

Treatment:

Device: clinical application of robotic technique

Microhands robotic TME

Experimental group

Treatment:

Device: clinical application of robotic technique

laparoscopic surgery TME

Active Comparator group

Treatment:

Device: clinical application of robotic technique