Natural Orifice Specimen Extraction SurgeryNCT06454201
Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer
A study testing robotic natural orifice specimen extraction surgery and robotic transabdominal specimen extraction surgery in people with Natural Orifice Specimen Extraction Surgery and Middle Rectal Cancer, run by Nanchang University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the short-term outcomes of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery in the treatment of median rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Natural Orifice Specimen Extraction Surgery, Middle Rectal Cancer, Robotic
- What is being tested?
- robotic natural orifice specimen extraction surgery and robotic transabdominal specimen extraction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is more than 18 years old and less than or equal to 85 years old
- Eastern Cooperative Oncology Group score ≤2
- Preoperative pathological diagnosis of rectal adenocarcinoma
- cT1-3NxM0 median rectal cancer defined by preoperative contrast-enhanced MRI
- The maximum diameter of tumor ≤5cm on preoperative enhanced MRI
- The body can tolerate the operation and sign the informed consent
Who cannot join
- multiple primary colorectal cancer
- recurrent rectal cancer
- preoperative neoadjuvant chemoradiotherapy
- complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery
- previous anal surgery history
- BMI≥30kg/m2
- severe mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: the First Affiliated Hospital of Nanchang University
The purpose of this study is to evaluate the short-term outcomes of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery in the treatment of median rectal cancer. The main question it aims to answer is: is it safe and feasible to perform roboric natural orifice specimen extraction surgery (NOSES-II) for median rectal cancer? What are the advantages of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery for median rectal cancer.
Read the detailed description
A major concern to the safety of the public's health is the prevalence of colorectal cancer, which is the third most prevalent cancer and has a very high fatality rate. There are multiple treatments for rectal cancer, and surgery remains one of the most important ways. Laparoscopic surgery as a minimally invasive technique for the treatment of colorectal has been confirmed by many studies to ensure its safety and reliability. Laparoscopic surgery has also been widely used in clinical. So far, NOSES, as an emerging minimally invasive technology, has caused heated discussions in the minimally invasive surgical community, especially in rectal surgery, the emergence of NOSES, which solves the problems caused by incisions in traditional surgery, improves the mental health of patients, and has good short-term efficacy. In recent years, the popularity of robotic colorectal cancer surgery has been rising, and the concepts of radical treatment, precision, and minimally invasive have been continuously refined, and NOSES surgery, as an emerging minimally invasive technology, has further reduced the impact of surgical trauma on the body, eliminated abdominal scar incision, and avoided complications related to abdominal wall incision, and has been widely used and carried out. In addition to the benefits of patients, the high-definition lens of the robotic surgery system and the flexible robotic arm greatly remove the trembling of the operator's hand, improve the flexibility and accuracy of the operator's operation, and are more conducive to challenging operations in narrow spaces. Compared with laparoscopy, the robotic surgical system has great advantages in some aspects, such as postoperative patient urination function, sexual function, surgical complications. Robotic surgical systems, combined with NOSES, may bring greater benefits to patients.
- Conditions
- Natural Orifice Specimen Extraction Surgery, Middle Rectal Cancer, Robotic, Short-term Outcomes
- Being tested
- robotic natural orifice specimen extraction surgery, robotic transabdominal specimen extraction surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic natural orifice specimen extraction surgeryProcedure or surgery
After the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Then the rectal stump was incised and disinfected with iodophor, the protective sleeve was placed into the abdominal cavity through the assistant hole. An assistant delivered oval forceps into the pelvic cavity through the anus and used oval forceps to grip one end of the protective sleeve. Then slowly pulled out the protective sleeve. Eventually, one end of the protective sleeve was placed inside the abdominal cavity and the other outside the anus, completely covering the rectal stump and the perianal area. Tumor was pulled out of the rectal stump, then the colon was then disconnected at 10 cm above the tumor. The anvil was placed into the stump of the sigmoid colon and disinfected with iodophor, and then the anvil was delivered into the abdominal cavity. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon.
robotic transabdominal specimen extraction surgeryProcedure or surgery
After the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Take a 6cm incision through the rectus abdominis muscle in the lower left abdomen and place an incision protective cover. Cut off the intestinal tube 10cm from the upper edge of the tumor and place a stapler base. The rectal stump was sutured with purse-string suture. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon. After completion of digestive tract reconstruction. The pelvic and abdominal cavities were washed repeatedly with normal saline until there were no blood remained. Close the abdominal cavity layer by layer.
| Study group | Role | What they receive |
|---|---|---|
| robotic natural orifice specimen extraction surgery for middle rectal cancer | Active comparator | After the body is free, the tumor segment of the bowel is pulled out through the anus. Excise the tumor segment of the colon outside the anus. Receives: Procedure: robotic natural orifice specimen extraction surgery |
| robotic transabdominal specimen extraction surgery for middle rectal cancer | Sham comparator | After internal mobilization, the tumor segment of the bowel was removed through an abdominal incision. Excise the tumor segment of the bowel outside the incision. Receives: Procedure: robotic transabdominal specimen extraction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of all complications
incidence rate
Measured: 1 months after surgery
The rate of all complications (Clavien-Dindo grade ≥ III )
incidence rate
Measured: 1 months after surgery
The rate of anastomotic complications
Anastomotic leakage and anastomotic bleeding
Measured: 1 months after surgery
Secondary outcomes (4)
operative time
minutes
Measured: Intraoperative
estimation of blood loss
milliliters
Measured: Intraoperative
postoperative hospital stay
days
Measured: 1 day after operation
visual analogue pain score
score
Measured: 1 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Natural Orifice Specimen Extraction SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taiyuan Li, Nanchang University
- Investigators
- shanping Ye, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454201
- Sponsor's protocol ID
- IIT2024013
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li TY, Min FZ, Yu T, Luo AL, Ye SP. A randomized controlled trial comparing robotic NOSES versus robotic TME for Mid-rectal cancer: short-term oncological and perioperative outcomes. J Robot Surg. 2026 May 21;20(1):516. doi: 10.1007/s11701-026-03494-3.
PubMed 42162355
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the First Affiliated Hospital of Nanchang University
- ClinicalTrials.gov ID
- NCT06454201
- Acronym / sponsor ID
- IIT2024013
- Conditions
- Natural Orifice Specimen Extraction Surgery, Middle Rectal Cancer, Robotic, Short-term Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Jun 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.
The purpose of this study is to evaluate the short-term outcomes of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery in the treatment of median rectal cancer. The main question it aims to answer is: is it safe and feasible to perform roboric natural orifice specimen extraction surgery (NOSES-II) for median rectal cancer? What are the advantages of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery for median rectal cancer.
Detailed description
A major concern to the safety of the public's health is the prevalence of colorectal cancer, which is the third most prevalent cancer and has a very high fatality rate. There are multiple treatments for rectal cancer, and surgery remains one of the most important ways. Laparoscopic surgery as a minimally invasive technique for the treatment of colorectal has been confirmed by many studies to ensure its safety and reliability. Laparoscopic surgery has also been widely used in clinical. So far, NOSES, as an emerging minimally invasive technology, has caused heated discussions in the minimally invasive surgical community, especially in rectal surgery, the emergence of NOSES, which solves the problems caused by incisions in traditional surgery, improves the mental health of patients, and has good short-term efficacy. In recent years, the popularity of robotic colorectal cancer surgery has been rising, and the concepts of radical treatment, precision, and minimally invasive have been continuously refined, and NOSES surgery, as an emerging minimally invasive technology, has further reduced the impact of surgical trauma on the body, eliminated abdominal scar incision, and avoided complications related to abdominal wall incision, and has been widely used and carried out. In addition to the benefits of patients, the high-definition lens of the robotic surgery system and the flexible robotic arm greatly remove the trembling of the operator's hand, improve the flexibility and accuracy of the operator's operation, and are more conducive to challenging operations in narrow spaces. Compared with laparoscopy, the robotic surgical system has great advantages in some aspects, such as postoperative patient urination function, sexual function, surgical complications. Robotic surgical systems, combined with NOSES, may bring greater benefits to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic natural orifice specimen extraction surgery for middle rectal cancer | Active comparator | Procedure: robotic natural orifice specimen extraction surgeryAfter the body is free, the tumor segment of the bowel is pulled out through the anus. Excise the tumor segment of the colon outside the anus. |
| robotic transabdominal specimen extraction surgery for middle rectal cancer | Sham comparator | Procedure: robotic transabdominal specimen extraction surgeryAfter internal mobilization, the tumor segment of the bowel was removed through an abdominal incision. Excise the tumor segment of the bowel outside the incision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age is more than 18 years old and less than or equal to 85 years old
- Eastern Cooperative Oncology Group score ≤2
- Preoperative pathological diagnosis of rectal adenocarcinoma
- cT1-3NxM0 median rectal cancer defined by preoperative contrast-enhanced MRI
- The maximum diameter of tumor ≤5cm on preoperative enhanced MRI
Key exclusion criteria (7 listed)
- multiple primary colorectal cancer
- recurrent rectal cancer
- preoperative neoadjuvant chemoradiotherapy
- complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery
- previous anal surgery history
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 |
|---|---|---|
| robotic natural orifice specimen extraction surgeryAfter the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Then the rectal stump was incised and disinfected with iodophor, the protective sleeve was placed into the abdominal cavity through the assistant hole. An assistant delivered oval forceps into the pelvic cavity through the anus and used oval forceps to grip one end of the protective sleeve. Then slowly pulled out the protective sleeve. Eventually, one end of the protective sleeve was placed inside the abdominal cavity and the other outside the anus, completely covering the rectal stump and the perianal area. Tumor was pulled out of the rectal stump, then the colon was then disconnected at 10 cm above the tumor. The anvil was placed into the stump of the sigmoid colon and disinfected with iodophor, and then the anvil was delivered into the abdominal cavity. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon. | Procedure or surgery | robotic natural orifice specimen extraction surgery for middle rectal cancer |
| robotic transabdominal specimen extraction surgeryAfter the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Take a 6cm incision through the rectus abdominis muscle in the lower left abdomen and place an incision protective cover. Cut off the intestinal tube 10cm from the upper edge of the tumor and place a stapler base. The rectal stump was sutured with purse-string suture. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon. After completion of digestive tract reconstruction. The pelvic and abdominal cavities were washed repeatedly with normal saline until there were no blood remained. Close the abdominal cavity layer by layer. | Procedure or surgery | robotic transabdominal specimen extraction surgery for middle rectal cancer |
Primary outcome
The rate of all complications
Time frame: 1 months after surgery
incidence rate
The rate of all complications (Clavien-Dindo grade ≥ III )
Time frame: 1 months after surgery
incidence rate
The rate of anastomotic complications
Time frame: 1 months after surgery
Anastomotic leakage and anastomotic bleeding
4 secondary outcomes
operative time
Time frame: Intraoperative
estimation of blood loss
Time frame: Intraoperative
postoperative hospital stay
Time frame: 1 day after operation
visual analogue pain score
Time frame: 1 weeks 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 30 Jan 2026.
- Derived from this study: PubMed 42162355Li TY, Min FZ, Yu T, Luo AL, Ye SP. A randomized controlled trial comparing robotic NOSES versus robotic TME for Mid-rectal cancer: short-term oncological and perioperative outcomes. J Robot Surg. 2026 May 21;20(1):516. doi: 10.1007/s11701-026-03494-3.
- Individual participant dataSharing planned: No
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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.
shanping Ye study chair
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic natural orifice specimen extraction surgery and robotic transabdominal specimen extraction surgery in people with Natural Orifice Specimen Extraction Surgery and Middle Rectal Cancer, run by Nanchang University at 1 site 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 6 inclusion and 7 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The rate of all complications (time frame: 1 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454201, which also lists 1 linked publication.
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 30 Jan 2026.