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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: clinical application of robotic technique

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Yi, MD; Phone Number: 13786179533; Email: yibo2018pro@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Bo Yi, MD; Phone Number: 13786179533; Email: yibo2018pro@126.com
      • Contact: Bo Yi, MD; Phone Number: 13786179533; Email: 1459082987@qq.com
      • Principal Investigator: Bo Yi, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: da Vinci robotic TME	Device: clinical application of robotic technique; effect of various surgical technique on clinical efficacy of TME
Experimental: Microhands robotic TME	Device: clinical application of robotic technique; effect of various surgical technique on clinical efficacy of TME
Active Comparator: laparoscopic surgery TME	Device: clinical application of robotic technique; effect of various surgical technique on clinical efficacy of TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	evaluation of genitourinary function	preoperation，1、3、6、12 months after operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: general surgery 3

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: YB2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes