Clinical trial NCT05457426: Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision
Official title: Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision: a Retrospective Multicenter Study With Propensity Score Matching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Outcomes
Oncological Outcomes
Keywords: Robot
Right hemicolectomy
Complete mesocolic excision
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: diseasefree survival(months)
timeFrame: until July 2021
measure: overall survival(months)
timeFrame: until July 2021
Secondary outcomes:
measure: conversion rates
timeFrame: during the surgery
measure: operative time
timeFrame: during the surgery
measure: estimated blood loss
timeFrame: during the surgery
measure: oral retake
timeFrame: up to 30 days after surgery
measure: time to return to bowel function
timeFrame: up to 30 days after surgery
measure: length of stay
timeFrame: up to 30 days after surgery
measure: total hospitalization cost
timeFrame: up to 30 days after surgery
measure: complications
timeFrame: up to 30 days after surgery
measure: harvest lymph nodes
timeFrame: up to 7 days after surgery
measure: lymph node metastasis
timeFrame: up to 7 days after surgery
Other outcomes:
Locations:
city: Wanzhou
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Yuzhong
country: China
facility: Army Medical Center
state: Chongqing
city: Lanzhou
country: China
facility: No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army
state: Gansu
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.