Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision: a Retrospective Multicenter Study With Propensity Score Matching

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Outcomes; Oncological Outcomes
• Intervention / Treatment: Procedure: robotic right hemicolectomy with CME

Detailed Description

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. A retrospective review of multicenter institutional database was conducted. The Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has been employed since 2016 in three centers. From July 2016 to July 2021, an initial cohort of 412 consecutive patients underwent robotic or laparoscopic right hemicolectomy with CME in three departments. With 30 cases meeting the exclusion criteria, 382 cases, including 204 males and 178 females, were available for inclusion. Of these, 149 cases by robotic right hemicolectomy with CME were classified as the robotic group, while the other 233 cases by laparoscopic right hemicolectomy with CME as the laparoscopic group.

• Study Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Wanzhou, Chongqing, China, 404031
      • Chongqing University Three Gorges Hospital
    • Yuzhong, Chongqing, China, 400042
      • Army Medical Center
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Multiple primary colorectal tumors
2. Metastasis to abdominal
3. Pelvic or distant organs
4. Accompanied with bowel obstruction or perforation
5. Neuroendocrine tumors
6. Lymphomas
7. Other malignant tumors.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion rates	the incidence of a conversion to open surgery	during the surgery
operative time	the miniutes of surgery from skin to skin	during the surgery
estimated blood loss	the mililiter of the blood loss during surgery	during the surgery
oral retake	the patients begin to recover intake	up to 30 days after surgery
time to return to bowel function	the patients begin to recover bowel function	up to 30 days after surgery
length of stay	the days of hospital stay	up to 30 days after surgery
total hospitalization cost	the total cost of this treatment by RMB	up to 30 days after surgery
complications	Postoperative complications, such as ileus, anastomotic leak, small intestinal obstruction, bleeding and so on. Number of Participants with complications will be recorded.	up to 30 days after surgery
harvest lymph nodes	the number of harvest lymph nodes in postoperative pathological report	up to 7 days after surgery
lymph node metastasis	the number of patients with lymph node metastasis	up to 7 days after surgery

Collaborators and Investigators

• Sponsor: Third Military Medical University

Publications and helpful links

General Publications

• 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.
• Ferri V, Quijano Y, Nuñez 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.
• 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. Erratum in: Ann Surg Oncol. 2019 Dec;26(Suppl 3):884.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Robot; Complete mesocolic excision; Right hemicolectomy
• Other Study ID Numbers: 20220623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No