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NCT Number: NCT04855448

Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots

Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

About this study

The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • histologically confirmed rectal cancer; ASA score ≤ 3

Exclusion criteria

  • palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery

Treatment and study plan

Micro Hand S robot and da Vinci robot

Device

The surgeries are performed with the Micro Hand S robot and da Vinci robot

da Vinci robot

Device

The surgeries are performed with the da Vinci robot

Primary outcomes

  1. learning curve of console time

    Time frame: up to 1 week after operation

    It was defined the cumulative sum plot of the consloe time in the chronological order.

  2. learning curve of docking time

    Time frame: up to 1 week after operation

    It was defined the cumulative sum plot of the docking time in the chronological order.

  3. learning curve of surgicla failure

    Time frame: up to 1 week after operation

    It was defined the cumulative sum plot of the docking time in the chronological order.

Secondary outcomes

  1. Type of surgical procedure

    Time frame: up to 1 week after operation

    It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection

  2. Operative time (min)

    Time frame: up to 1 week after operation

    It was defined as the duration from skin incision to skin closure

  3. Console time (min)

    Time frame: up to 1 week after operation

    The console time was defined the fime that the surgeon performed the surgeon console.

  4. Docking time (min)

    Time frame: up to 1 week after operation

    The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites

  5. Conversion

    Time frame: up to 1 week after operation

    Conversion was defined as any change in strategy to open surgery

  6. Bloos loss (ml)

    Time frame: up to 1 week after operation

    It was defined as the amount of blood in the whole surgical time

  7. Hospital stay (day)

    Time frame: up to 1 month after operation

    It was defined as the length of hospital stay

  8. Protective ileostomy

    Time frame: up to 1 month after operation

    It was defined as ileostomy which diverted the feces to to ensure anastomotic healing

  9. Retrieved lymph node

    Time frame: up to 1 month after operation

    It was defined as the number of all the lymph nodes for each patient

  10. Surgical failure

    Time frame: up to 1 month after operation

    Surgical failure was defined as the presence of one or more of the following four parameters: conversion, the positive surgical margins, severe postoperative complications, the number of harvested lymph nodes less than 12

  11. pTNM stage

    Time frame: up to 1 month after operation

    It was defined as the pathological stage of the tumor according the TNM classification

  12. Tumor size (cm)

    Time frame: up to 1 month after operation

    It was defined as the longitudinal diameter of the tumor

  13. Length of distal ressction margin (cm)

    Time frame: up to 1 month after operation

    It was defined as the distance betwen the distal resection margin and the low margin of the tumor

  14. Status of the surgical margin

    Time frame: up to 1 month after operation

    It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope

  15. Quality of specimen

    Time frame: up to 1 month after operation

    The quality of the speciman was graded according to the protocol proposed by Quirke

  16. Postoperative complication

    Time frame: up to 1 month after operation

    It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification

  17. Local recurrence

    Time frame: at least 1 years after operation

    It was defined as the tumor was again found in the pelvic cavity

  18. Disease free survival

    Time frame: at least 1 years after operation

    It was defined as the duration between the operation and date of the tumor recurrence

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study title

Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 22, 2021
Registry last updated
Apr 22, 2021

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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