Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

Perioperative Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457426
• Other study ID #: 20220623
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: June 22, 2022

Study information

• Verified date: July 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: June 22, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perioperative Outcomes

Intervention

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.

Locations

Country	Name	City	State
China	No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army	Lanzhou	Gansu
China	Chongqing University Three Gorges Hospital	Wanzhou	Chongqing
China	Army Medical Center	Yuzhong	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View 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 a — View 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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diseasefree survival(months)	Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.	until July 2021
Primary	overall survival(months)	Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.	until July 2021
Secondary	conversion rates	the incidence of a conversion to open surgery	during the surgery
Secondary	operative time	the miniutes of surgery from skin to skin	during the surgery
Secondary	estimated blood loss	the mililiter of the blood loss during surgery	during the surgery
Secondary	oral retake	the patients begin to recover intake	up to 30 days after surgery
Secondary	time to return to bowel function	the patients begin to recover bowel function	up to 30 days after surgery
Secondary	length of stay	the days of hospital stay	up to 30 days after surgery
Secondary	total hospitalization cost	the total cost of this treatment by RMB	up to 30 days after surgery
Secondary	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
Secondary	harvest lymph nodes	the number of harvest lymph nodes in postoperative pathological report	up to 7 days after surgery
Secondary	lymph node metastasis	the number of patients with lymph node metastasis	up to 7 days after surgery