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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05457426
Other study ID # 20220623
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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