Rectal CancerNCT06405308
Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer
An observational study of Rectal Cancer and Robotic Surgery, run by Taiyuan Li at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 86 years
- Conditions the study is for
- Rectal Cancer, Robotic Surgery, Natural Orifice Specimen Extraction Surgery
- What is being tested?
- R-NOSES group and R-TSES group
- Type of treatment
- Surgery or procedure
- How many people
- 636 participants
- Where
- 8 sitesChina
- Study dates
- 1 Oct 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023.
Who may be able to join
- histologically confirmed rectal adenocarcinoma
- robotic TME for rectal adenocarcinoma
- postoperative pathological staging of T1-2N0M0
- complete surgical and postoperative follow-up information
Who cannot join
- body mass index (BMI) ≥ 35 kg/m2
- history of abdominal surgery
- history of pelvic surgery
- presence of another primary cancer
- previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
- anal or vaginal disease
Show all 9Show fewer
- ileostomy or transverse colostomy
- conversion to open operation
- tumor distant metastasis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Three Gorges Hospital Affiliated to Chongqing University
Chongqing
Fujian Cancer Hospital
Fuzhou
The Second Affiliated Hospital of Harbin Medical University
Harbin
The First Affiliated Hospital of Nanchang University
Nanchang
Zhongshan Hospital, Fudan University
Shanghai
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis
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.
Read the detailed description
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.
- Being tested
- R-NOSES group, R-TSES group
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-NOSES groupProcedure or surgery
robotic natural orifice specimen extraction surgery
R-TSES groupProcedure or surgery
robotic transabdominal specimen extraction surgery
| Study group | Role | What they receive |
|---|---|---|
| R-NOSES group | Participants in this group underwent robotic natural orifice specimen extraction surgery Receives: Procedure: R-NOSES group | |
| R-TSES group | Participants in this group underwent robotic transabdominal specimen extraction surgery Receives: Procedure: R-TSES group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
Measured: Up to 30 days postoperatively
Secondary outcomes (9)
Operative time
Measured: Intraoperative
Estimated blood loss
Measured: Intraoperative
Postoperative recovery composite
Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours) and time to first oral feeding.
Measured: Up to 2 weeks
Postoperative hospital stay
From surgery to discharge
Measured: Up to 4 weeks
Pain assessment
Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.
Measured: 1, 3, 5 days postoperatively
C-reactive protein (CRP)
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Measured: 1, 3, 5 days postoperatively
Postoperative white blood
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Measured: 1, 3, 5 days postoperatively
EORTC QLQ-C30
The EORTC QLQ-C30 includes functional score, symptom score, and Global Health Status. All project scores range from 0 to 100. The Functional score includes physical functioning, role functioning, emotion functioning, social functioning and cognitive functioning. The higher the functional score, the better the functional status of the patient. Symptom score includes nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation, diarrhea, financial impact. A higher symptom score is associated with more severe symptoms and worse outcomes. The higher the Global Health Status, the better the health of the patient.
Measured: Three months after surgery
BIQ
The BIQ is an eight-item questionnaire incorporating body image and cosmetic subscales, The body image scale measures patients' perception and satisfaction with their bodies after surgery. it ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars for a score range of 3-24, with a higher score indicating greater cosmetic satisfaction.
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Oct 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiyuan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taiyuan Li, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405308
- Sponsor's protocol ID
- NOSES-2024
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis
- ClinicalTrials.gov ID
- NCT06405308
- Acronym / sponsor ID
- NOSES-2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Taiyuan LiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-NOSES group | – | Procedure: R-NOSES groupParticipants in this group underwent robotic natural orifice specimen extraction surgery |
| R-TSES group | – | Procedure: R-TSES groupParticipants in this group underwent robotic transabdominal specimen extraction surgery |
Who may qualify
- Ages
- 20 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023.
Key inclusion criteria (4 listed)
- histologically confirmed rectal adenocarcinoma
- robotic TME for rectal adenocarcinoma
- postoperative pathological staging of T1-2N0M0
- complete surgical and postoperative follow-up information
Key exclusion criteria (9 listed)
- body mass index (BMI) ≥ 35 kg/m2
- history of abdominal surgery
- history of pelvic surgery
- presence of another primary cancer
- previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-NOSES grouprobotic natural orifice specimen extraction surgery | Procedure or surgery | R-NOSES group |
| R-TSES grouprobotic transabdominal specimen extraction surgery | Procedure or surgery | R-TSES group |
Primary outcome
Complication rate
Time frame: Up to 30 days postoperatively
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
9 secondary outcomes
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Postoperative recovery composite
Time frame: Up to 2 weeks
Postoperative hospital stay
Time frame: Up to 4 weeks
Pain assessment
Time frame: 1, 3, 5 days postoperatively
C-reactive protein (CRP)
Time frame: 1, 3, 5 days postoperatively
Postoperative white blood
Time frame: 1, 3, 5 days postoperatively
EORTC QLQ-C30
Time frame: Three months after surgery
BIQ
Time frame: Three months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Robotic Surgery, run by Taiyuan Li at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: Up to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.