NCT05457426

Brief Summary

the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

June 23, 2022

Last Update Submit

July 18, 2022

Conditions

Perioperative OutcomesOncological Outcomes

Keywords

RobotRight hemicolectomyComplete mesocolic excision

Outcome Measures

Primary Outcomes (2)

  • diseasefree survival(months)

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

    until July 2021

  • overall survival(months)

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

    until July 2021

Secondary Outcomes (10)

  • conversion rates

    during the surgery

  • operative time

    during the surgery

  • estimated blood loss

    during the surgery

  • oral retake

    up to 30 days after surgery

  • time to return to bowel function

    up to 30 days after surgery

  • +5 more secondary outcomes

Study Arms (2)

robotic right hemicolectomy with CME

The robot was set to come and dock from the right shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook/scissors for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R2), and Cadiere's fenestrated forceps in the right lower quadrant port (R3) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transverse mesocolon with the grasp in R3, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R2. All procedures were performed keeping the principle of complete mesocolic excision.

Procedure: robotic right hemicolectomy with CME

laparoscopic right hemicolectomy with CME

In the aparoscopic group, five trocars were used: a periumbilical incision and left upper quadrant for 12-mm trocars, both lower quadrants for 5-mm trocars, and the right quadrant for one more 5-mm trocar. A 30 degrees laparoscope was inserted through the periumbilical trocar site. After insertion of the trocars, the patient was placed in the Trendelenburg position with a 15 degrees rightward tilt. An ultrasonic device was used for dissection. All procedures were performed keeping the principle of complete mesocolic excision.

Interventions

robotic right hemicolectomy with CMEPROCEDURE

The distribution of trocars was placed according to the position of Intuitive Surgical Inc. for robotic colectomy. The robot was set to come and dock from theright shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R3), and Cadiere's fenestrated forceps in the right lower quadrant port (R2) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transversemesocolon with the grasp in R2, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R3.

robotic right hemicolectomy with CME

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing; Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing; Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study

You may qualify if:

  • Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon.
  • Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs.
  • The patient underwent robotic or laparoscopic right hemicolectomy with CME.

You may not qualify if:

  • Multiple primary colorectal tumors
  • Metastasis to abdominal
  • Pelvic or distant organs
  • Accompanied with bowel obstruction or perforation
  • Neuroendocrine tumors
  • Lymphomas
  • Other malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, 404031, China

Location

Army Medical Center

Yuzhong, Chongqing Municipality, 400042, China

Location

No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army

Lanzhou, Gansu, 730050, China

Location

Related Publications (3)

  • Yozgatli TK, Aytac E, Ozben V, Bayram O, Gurbuz B, Baca B, Balik E, Hamzaoglu I, Karahasanoglu T, Bugra D. Robotic Complete Mesocolic Excision Versus Conventional Laparoscopic Hemicolectomy for Right-Sided Colon Cancer. J Laparoendosc Adv Surg Tech A. 2019 May;29(5):671-676. doi: 10.1089/lap.2018.0348. Epub 2019 Feb 26.

    PMID: 30807257RESULT

  • Ferri V, Quijano Y, Nunez J, Caruso R, Duran H, Diaz E, Fabra I, Malave L, Isernia R, d'Ovidio A, Agresott R, Gomez P, Isojo R, Vicente E. Robotic-assisted right colectomy versus laparoscopic approach: case-matched study and cost-effectiveness analysis. J Robot Surg. 2021 Feb;15(1):115-123. doi: 10.1007/s11701-020-01084-5. Epub 2020 May 4.

    PMID: 32367439RESULT

  • Spinoglio G, Bianchi PP, Marano A, Priora F, Lenti LM, Ravazzoni F, Petz W, Borin S, Ribero D, Formisano G, Bertani E. Robotic Versus Laparoscopic Right Colectomy with Complete Mesocolic Excision for the Treatment of Colon Cancer: Perioperative Outcomes and 5-Year Survival in a Consecutive Series of 202 Patients. Ann Surg Oncol. 2018 Nov;25(12):3580-3586. doi: 10.1245/s10434-018-6752-7. Epub 2018 Sep 14.

    PMID: 30218248RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointestinal Surgery

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 14, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 22, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

CN(3)