NCT06824688

Brief Summary

Single-port versus multi-port robotic surgery for rectal cancer

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2025

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

December 25, 2024

Last Update Submit

September 15, 2025

Conditions

Rectal Cancer PatientsRobotic Surgical Procedures

Outcome Measures

Primary Outcomes (2)

  • Incidence of perioperative complications

    Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days.

    Intraoperative and postoperative 30 days

  • Number of participants with conversion procedures

    The number of patients converted from robotic to open or laparoscopic surgery

    Date of surgery (Day 1)

Secondary Outcomes (3)

  • Pain scores

    Postoperative days 1-3

  • Quality of specimen

    Date of surgery (Day 1)

  • Total length of incisions

    Date of surgery (Day 1)

Study Arms (2)

Single-port robotic total mesorectal excision

EXPERIMENTAL

Single-port robotic total mesorectal excision

Procedure: Single-port robotic total mesorectal excision

Multi-port robotic total mesorectal excision

ACTIVE COMPARATOR

Multi-port robotic total mesorectal excision

Procedure: Multi-port robotic total mesorectal excision

Interventions

Single-port robotic total mesorectal excisionPROCEDURE

Single-port robotic total mesorectal excision

Single-port robotic total mesorectal excision
Multi-port robotic total mesorectal excisionPROCEDURE

Multi-port robotic total mesorectal excision

Multi-port robotic total mesorectal excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huichao Zheng

Chongqing, China

RECRUITING

Study Officials

  • Fan Li

    Army Medical Center (Daping Hospital), Army Medical University

    STUDY DIRECTOR

Central Study Contacts

Huichao Zheng, MD

CONTACT

68757350625730455@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2024

First Posted

February 13, 2025

Study Start

October 23, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2025

Record last verified: 2024-10

Locations

CN(1)