Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

NCT ID: NCT05457426

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 382 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-06-22

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.

Conditions

Perioperative Outcomes; Oncological Outcomes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

robotic right hemicolectomy with CME

Intervention Type: PROCEDURE

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weidong Tong

Director of Gastrointestinal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, China

Army Medical Center

Yuzhong, Chongqing Municipality, China

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

Lanzhou, Gansu, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 30807257 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32367439 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30218248 (View on PubMed)

Other Identifiers

20220623

Identifier Type: -

Identifier Source: org_study_id