To hear about similar clinical trials, please enter your email below
Trial Title:
Single-port Robotic Versus Laparoscopic Transanal Total Mesorectal Excision
NCT ID:
NCT06591572
Condition:
Rectal Cancer Patients
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Single-port robotic
transanal total mesorectal excision
rectal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Single-port robotic transanal total mesorectal excision
Description:
Rectal resection by transanal TME with single-port robotic surgery
Arm group label:
Single-port robotic transanal total mesorectal excision
Intervention type:
Procedure
Intervention name:
Laparoscopic transanal total mesorectal excision
Description:
Rectal resection by transanal TME with Laparoscopic surgery
Arm group label:
Laparoscopic transanal total mesorectal excision
Summary:
This is a phase 2a clinical trial based on the IDEAL framework to evaluate the safety,
feasibility and clinical efficacy of Single-port robotic transanal total mesorectal
excision (SPr-taTME )surgery. The intraoperative complications, postoperative
complications, perioperative recovery effects, quality of surgical specimens,
pathological indexes and oncology effects of SPr-taTME and laparoscopic transanal total
mesorectal excision (L-taTME) in the treatment of middle and low rectal cancer were
compared.
Detailed description:
The intraoperative complications, postoperative complications, perioperative recovery
effects, quality of surgical specimens, pathological indexes and oncology effects of
SPr-taTME and laparoscopic transanal total mesorectal excision (L-taTME) in the treatment
of middle and low rectal cancer were compared.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (1) Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition); (2)
Histological biopsy showing adenocarcinoma; (3) Stage I-III (MRI and abdominal CT),
including the downstaged after neoadjuvant therapy; (4) Intention for primary
anastomosis; (5) Obtain the informed consent of the patient and his family; (6)
Suitable for robotic or laparoscopic surgery. (7) Over 18 years old.
Exclusion Criteria:
1. T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour,
determined by MRI-scan (staged after (chemo)radiotherapy if applicable) ;
2. The anal sphincter complex or levator anal muscle is involved;
3. Previous prostate or rectal surgery (excluding local excision) ;
4. Emergency surgery was performed due to complications of a rectal tumor;
5. Malignancy other than adenocarcinoma at histological examination;
6. Pregnancy;
7. Signs of acute intestinal obstruction;
8. Multiple colorectal tumours;
9. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal
Cancer (HNPCC), active Crohn's disease or active ulcerative colitis;
10. Planned synchronous abdominal organ resections;
11. Other malignancies in medical history, except adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri;
12. Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as
severe cardiovascular or respiratory disease (ASA class > III)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huichao Zheng
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
Huichao Zheng, MD
Phone:
86-18375924232
Email:
625730455@qq.com
Start date:
October 24, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency class:
Other
Source:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06591572
