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

NCT06409403 | Recruiting FDA Device

• 1 other identifier: YB2017
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS)

  evaluation of genitourinary function

  preoperation，1、3、6、12 months after operation

Secondary Outcomes (9)

• International Index of Erectile Function (IIEF)

  preoperation，1、3、6、12 months after operation

• Female Sexual Function Index (FSFI)

  preoperation，1、3、6、12 months after operation

• operative time

  perioperative

• blood loose

  perioperative

• conversion

  perioperative

Study Arms (3)

da Vinci robotic TME

EXPERIMENTAL

Device: clinical application of robotic technique

Microhands robotic TME

EXPERIMENTAL

Device: clinical application of robotic technique

laparoscopic surgery TME

ACTIVE COMPARATOR

Device: clinical application of robotic technique

Interventions

clinical application of robotic technique DEVICE

effect of various surgical technique on clinical efficacy of TME

Microhands robotic TME; da Vinci robotic TME; laparoscopic surgery TME

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• general surgery 3: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Bo Yi, MD

CONTACT

13786179533; yibo2018pro@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastrointestinal Surgery

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: January 1, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)