Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06409403

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

Led by general surgery 3 · Updated on 2024-05-10

164

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Lesions confirmed by histopathological examination and staged preoperatively with pelvic MRI and CT scans
  • Patients aged 18 to 75 years
  • American Society of Anesthesiology (ASA) class 3 or lower
Not Eligible

You will not qualify if you...

  • Benign prostate hyperplasia
  • Previous bladder or prostate surgery
  • Severe sexual dysfunction (International Index of Erectile Function score less than 10 or Female Sexual Function Index score 26.55 or lower)
  • Urgent operation requirement
  • Simultaneous or heterochronous multiple primary rectal tumors
  • Presence of distant metastasis
  • Severe cardiopulmonary complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Actively Recruiting

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Research Team

B

Bo Yi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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