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NCT Number: NCT04836741

Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

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, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. 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

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

Device

The surgeries are performed with the Micro Hand S robot

Laparoscope

Device

The surgeries are performed with the laparoscope

Primary 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. Conversion

    Time frame: up to 1 week after operation

    Conversion was defined as any change in strategy to open surgery

  4. Bloos loss (ml)

    Time frame: up to 1 week after operation

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

  5. Protective ileostomy

    Time frame: up to 1 month after operation

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

  6. Hospital stay (day)

    Time frame: up to 1 month after operation

    It was defined as the length of hospital stay

  7. Tumor size (cm)

    Time frame: up to 1 month after operation

    It was defined as the longitudinal diameter of the tumor

  8. Retrieved lymph node

    Time frame: up to 1 month after operation

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

  9. pTNM stage

    Time frame: up to 1 month after operation

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

  10. 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

  11. 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

  12. 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

  13. 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

  14. International Prostate Symptom Score

    Time frame: at least12 months after operation

    It assessed the urination with 7 items

  15. International Index of Erectile Function

    Time frame: at least 12 months after operation

    It assessed erectile function with 5 items

  16. Local recurrence

    Time frame: at least 1 years after operation

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

  17. 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

Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 8, 2021
Registry last updated
Apr 8, 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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