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Trial Title:
Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer
NCT ID:
NCT06409403
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
clinical application of robotic technique
Description:
effect of various surgical technique on clinical efficacy of TME
Arm group label:
Microhands robotic TME
Arm group label:
da Vinci robotic TME
Arm group label:
laparoscopic surgery TME
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Yi, MD
Phone:
13786179533
Email:
1459082987@qq.com
Contact backup:
Last name:
Bo Yi, MD
Phone:
13786179533
Email:
yibo2018pro@126.com
Investigator:
Last name:
Bo Yi, md
Email:
Principal Investigator
Start date:
January 1, 2017
Completion date:
December 31, 2025
Lead sponsor:
Agency:
general surgery 3
Agency class:
Other
Source:
The Third Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06409403
