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Completed

NCT Number: NCT05457426

Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

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.

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Key information

Conditions

Perioperative Outcomes Oncological Outcomes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing University Three Gorges Hospital, Wanzhou, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon.
  • Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs.
  • The patient underwent robotic or laparoscopic right hemicolectomy with CME.

Exclusion criteria

  • Multiple primary colorectal tumors
  • Metastasis to abdominal
  • Pelvic or distant organs
  • Accompanied with bowel obstruction or perforation
  • Neuroendocrine tumors
  • Lymphomas
  • Other malignant tumors.

Treatment and study plan

robotic right hemicolectomy with CME

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.

Primary outcomes

  1. diseasefree survival(months)

    Time frame: until July 2021

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

  2. overall survival(months)

    Time frame: until July 2021

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

Secondary outcomes

  1. conversion rates

    Time frame: during the surgery

    the incidence of a conversion to open surgery

  2. operative time

    Time frame: during the surgery

    the miniutes of surgery from skin to skin

  3. estimated blood loss

    Time frame: during the surgery

    the mililiter of the blood loss during surgery

  4. oral retake

    Time frame: up to 30 days after surgery

    the patients begin to recover intake

  5. time to return to bowel function

    Time frame: up to 30 days after surgery

    the patients begin to recover bowel function

  6. length of stay

    Time frame: up to 30 days after surgery

    the days of hospital stay

  7. total hospitalization cost

    Time frame: up to 30 days after surgery

    the total cost of this treatment by RMB

  8. complications

    Time frame: 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.

  9. harvest lymph nodes

    Time frame: up to 7 days after surgery

    the number of harvest lymph nodes in postoperative pathological report

  10. lymph node metastasis

    Time frame: up to 7 days after surgery

    the number of patients with lymph node metastasis

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2022
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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