Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

Completed

• Conditions: Oncological Outcomes; Perioperative Outcomes
• Interventions: Procedure: robotic right hemicolectomy with CME

• Registration Number: NCT05457426
• Lead Sponsor: Third Military Medical University

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-22
• Study First Submitted: 2022-06-23
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-14
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
robotic right hemicolectomy with CME	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.

Primary Outcome Measures

Name	Time	Method
overall survival(months)	until July 2021	Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.
diseasefree survival(months)	until July 2021	Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Army Medical Center; 🇨🇳 Yuzhong, Chongqing, China

Chongqing University Three Gorges Hospital; 🇨🇳 Wanzhou, Chongqing, China

No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army; 🇨🇳 Lanzhou, Gansu, China