Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer

NCT ID: NCT06405308

Last Updated: 2024-05-13

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

Total Enrollment

636 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-15

Brief Summary

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A retrospective cohort study, conducted nationwide(China) and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES (robotic natural orifice specimen extraction surgery)with R-TSES (robotic transabdominal specimen extraction surgery) for early-stage rectal cancer.

Detailed Description

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In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.

Conditions

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Rectal Cancer Robotic Surgery Natural Orifice Specimen Extraction Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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R-NOSES group

Participants in this group underwent robotic natural orifice specimen extraction surgery

R-NOSES group

Intervention Type PROCEDURE

robotic natural orifice specimen extraction surgery

R-TSES group

Participants in this group underwent robotic transabdominal specimen extraction surgery

R-TSES group

Intervention Type PROCEDURE

robotic transabdominal specimen extraction surgery

Interventions

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R-NOSES group

robotic natural orifice specimen extraction surgery

Intervention Type PROCEDURE

R-TSES group

robotic transabdominal specimen extraction surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. histologically confirmed rectal adenocarcinoma
2. robotic TME for rectal adenocarcinoma
3. postoperative pathological staging of T1-2N0M0
4. complete surgical and postoperative follow-up information

Exclusion Criteria

1. body mass index (BMI) ≥ 35 kg/m2
2. history of abdominal surgery
3. history of pelvic surgery
4. presence of another primary cancer
5. previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
6. anal or vaginal disease
7. ileostomy or transverse colostomy
8. conversion to open operation
9. tumor distant metastasis
Minimum Eligible Age

20 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiyuan Li

OTHER

Sponsor Role lead

Responsible Party

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Taiyuan Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Three Gorges Hospital Affiliated to Chongqing University

Chongqing, , China

Site Status

Fujian Cancer Hospital

Fuzhou, , China

Site Status

The Second Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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NOSES-2024

Identifier Type: -

Identifier Source: org_study_id

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