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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Device: clinical application of robotic technique

• Registration Number: NCT06409403
• Lead Sponsor: general surgery 3

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
da Vinci robotic TME	clinical application of robotic technique	-
Microhands robotic TME	clinical application of robotic technique	-
laparoscopic surgery TME	clinical application of robotic technique	-

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	preoperation，1、3、6、12 months after operation	evaluation of genitourinary function

Secondary Outcome Measures

Name	Time	Method
conversion	perioperative	operative outcomes
complete TME specimens	perioperative	operative outcomes
blood loose	perioperative	operative outcomes
International Index of Erectile Function (IIEF)	preoperation，1、3、6、12 months after operation	evaluation of genitourinary function
Female Sexual Function Index (FSFI)	preoperation，1、3、6、12 months after operation	evaluation of genitourinary function
operative time	perioperative	operative outcomes
retrieved lymph nodes	perioperative	operative outcomes
circumferential resection margins (CRMs)	perioperative	operative outcomes
complication	perioperative	operative outcomes

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China