Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

NCT ID: NCT04836741

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Micro Hand S robot-assisted surgery

This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer

Group Type EXPERIMENTAL

Micro Hand S robot

Intervention Type DEVICE

The surgeries are performed with the Micro Hand S robot

Laparoscopic surgery

This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer

Group Type ACTIVE_COMPARATOR

Laparoscope

Intervention Type DEVICE

The surgeries are performed with the laparoscope

Interventions

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Micro Hand S robot

The surgeries are performed with the Micro Hand S robot

Intervention Type DEVICE

Laparoscope

The surgeries are performed with the laparoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

References

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Wang Y, Wang G, Li Z, Ling H, Yi B, Zhu S. Comparison of the operative outcomes and learning curves between laparoscopic and "Micro Hand S" robot-assisted total mesorectal excision for rectal cancer: a retrospective study. BMC Gastroenterol. 2021 Jun 7;21(1):251. doi: 10.1186/s12876-021-01834-1.

Reference Type DERIVED
PMID: 34098897 (View on PubMed)

Other Identifiers

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XY3-DSRCS1507A02

Identifier Type: -

Identifier Source: org_study_id

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