Natural Orifice Specimen Extraction SurgeryNCT06906952
A Prospective Single-center Randomized Controlled Trial of Robotic Surgery With Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon 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 Robotic Surgery, run by Nanchang University at 1 site in China.
Trial summary
This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon 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, Robotic Surgery, Short-term Outcomes
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1) The age is more than 18 years old and less than or equal to 85 years old 2) Eastern Cooperative Oncology Group score ≤2 3) Preoperative pathological diagnosis of rectal adenocarcinoma 4) cT1-3NxM0 rectal cancer defined by preoperative contrast-enhanced MRI 5) The maximum diameter of tumor ≤5cm on preoperative enhanced MRI 6) The body can tolerate the operation and sign the informed consent
Who cannot join
- 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) BMI≥30kg/m2 7) severe mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330000
Nanchang
About this study
This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.
- 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 |
|---|---|---|
| NOSES-IV Group | Experimental | 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 |
| non-NOSES Group | 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
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 posted2 Apr 2025
- Study start1 Oct 2024
- Primary completion31 May 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taiyuan Li, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906952
- Sponsor's protocol ID
- ZL078
- Status last verified
- Oct 2025
- First submitted
- 26 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Prospective Single-center Randomized Controlled Trial of Robotic Surgery With Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer
- ClinicalTrials.gov ID
- NCT06906952
- Acronym / sponsor ID
- ZL078
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Apr 2025 (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.
This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOSES-IV Group | Experimental | 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. |
| non-NOSES Group | 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 (1 listed)
- 1) The age is more than 18 years old and less than or equal to 85 years old 2) Eastern Cooperative Oncology Group score ≤2 3) Preoperative pathological diagnosis of rectal adenocarcinoma 4) cT1-3NxM0 rectal cancer defined by preoperative contrast-enhanced MRI 5) The maximum diameter of tumor ≤5cm on preoperative enhanced MRI 6) The body can tolerate the operation and sign the informed consent
Key exclusion criteria (1 listed)
- 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) BMI≥30kg/m2 7) severe mental illness
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 | NOSES-IV Group |
| 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 | non-NOSES Group |
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
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Robotic Surgery, 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 1 inclusion and 1 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: enrolling by invitation, 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?
This study is still under way. Results are not available in the source record yet.
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 2 primary outcomes in all. 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 30 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.