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

Colorectal Cancer Clinical Trial

Official title:

Study on Clinical Application of Robotic Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409403
• Other study ID #: YB2017
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: The Third Xiangya Hospital of Central South University
• Contact: Bo Yi, MD
• Phone: 13786179533
• Email: yibo2018pro[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• clinical application of robotic technique
effect of various surgical technique on clinical efficacy of TME

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
general surgery 3

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS)	evaluation of genitourinary function	preoperation,1?3?6?12 months after operation
Secondary	International Index of Erectile Function (IIEF)	evaluation of genitourinary function	preoperation,1?3?6?12 months after operation
Secondary	Female Sexual Function Index (FSFI)	evaluation of genitourinary function	preoperation,1?3?6?12 months after operation
Secondary	operative time	operative outcomes	perioperative
Secondary	blood loose	operative outcomes	perioperative
Secondary	conversion	operative outcomes	perioperative
Secondary	retrieved lymph nodes	operative outcomes	perioperative
Secondary	complete TME specimens	operative outcomes	perioperative
Secondary	circumferential resection margins (CRMs)	operative outcomes	perioperative
Secondary	complication	operative outcomes	perioperative