ClinicalTrials.gg
Status unknownNCT05970133Updated Sep 20, 2024

Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer

An interventional study of Colectomy with NOSE procedure in Colorectal Cancer, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2023, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.

Read the detailed description

Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the field of colorectal surgery. It has been widely accepted by surgeons and patients in light of the better peri-operative outcomes and analogical long-term effectiveness, compared with open surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery requires an additional abdominal incision for specimen retrieval and sometimes for intestinal reconstruction, which increases the risk of various postoperative complications, including pain, surgical site infection, incisional hernia, and injury to the epigastric artery and abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.

To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the anus, stomach, or vagina, was introduced. One randomized trial reported better short-term surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been found to be feasible, safe, and oncologically sound in selected cases. Several multiport laparoscopic platforms are currently available to complete all NOSE procedures and reestablish intestinal continuity with a single stapled anastomosis, which has been shown to improve short-term results compared with conventional laparoscopic colectomy. However, concerns remain regarding the long-term oncologic safety (tumor cell spillage with local recurrence and long-term survival) when NOSE is used for colorectal malignancy.

A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy. Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the presence of a skilled endoscopist who can snare and pull the specimen endoluminally through the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires a posterior colpotomy, an operative maneuver that is not typically performed by general or colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of standardization of the technique.

The demands for these technical skills are more important in removing right-sided colon pathology, as compared to left-sided pathology. There are inherent anatomic factors that make NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted through the lower gastrointestinal tract via distal colotomy must travel the length of the remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen. This technique is still performed in some centers, though limitations related to the size of the specimen are stricter than for left-sided colon lesions. This approach has little practicality due to its significant technical challenges, hence its limited use.

Bacterial contamination is always a concern during the NOSE procedure. Most researchers strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial contamination with NOSE was not significantly higher than that in conventional laparoscopic surgery. In some studies, patients who had NOSE did not experience significant postoperative morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal wound-related complications or leakage, than the conventional group.

Tumor size is considered before applying the NOSE procedure. Many authors limit indications to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not suitable for transrectal specimen extraction and set the BMI cutoff at > 28-35 kg/m2. Most researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic surgery with severe adhesions were not eligible for NOSE.

It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay, shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site infections and total perioperative complications. In general, the operative time in laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an abdominal incision is beneficial for the prevention of incisional hernia.

Currently, robotic surgical approaches are becoming more popular for treating colorectal cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery, including an unstable camera view and straight laparoscopic instruments. Robotic surgery is advantageous because it provides surgeon-control of the camera, high-definition three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom of angles of instruments, and the ability to simultaneously control the camera and two additional instruments that facilitate traction and countertraction, all of which enable to facilitate the procedures, even in difficult settings.

The unique advantages of the surgical robot make colorectal surgery operations more precise and intelligent, providing more options for minimizing operative stress during colorectal surgery. The proximity between the sigmoid colon and rectum to the anal location provides a favorable predisposition for transanal specimen retrieval without significantly increasing the difficulty of the surgical operation. However, to date, only very few studies compared robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our preliminary data has shown the safety and feasibility of robotic NOSE, as compared with laparoscopic NOSE for the surgery of colorectal cancer.

Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the oncologic concern of tumor spillage at the staple line during tumor retrieval process. In this respect, the introduction of robotic system can overcome the technical difficulties.

In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • Natural orifice specimen extraction
  • Laparoscopic surgery
  • Robotic surgery
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 300 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Primary colon cancers located at the left sided colonic anatomic location, including distal transverse colon, colonic splenic flexure, descending colon, sigm oid descending colonic junction, sigmoid colon and upper rectum that required the mobilization of colonic splenic flexure to facilitate a curative resection and trans anal specimen extraction ;
  2. TNM Stage I III adenocarcinomas;
  3. Curative and elective surgery;
  4. American Society of Anesthesiology (ASA) class I to III patients;
  5. Age >18 years.

Exclusion criteria

Exclusion Criteria:

  1. Cecal, ascending, the proximal and middle transverse colon cancers; and the middle or lower rectal cancers;
  2. Emergency or palliative surgery;
  3. Evidence of disseminated disease or adjacent organ invasion;
  4. Primary tumor mass >8 cm in diameter;
  5. Morbidly obese patients, that is, body mass index (BMI) ≥40 kg/m 2 ;
  6. Previous major surgery of upper abdomen or pelvis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Laparoscopic surgery

    The patients in this group will undergo laparoscopic surgery.

    Procedure: Colectomy with NOSE procedure

  • Active comparator
    Robotic surgery

    The patients in this group will undergo robotic surgery.

    Procedure: Colectomy with NOSE procedure

Interventions

  • ProcedureColectomy with NOSE procedure

    The specimen will be extract from the anus.

06

What researchers measure

Primary outcomes

  1. The surgical efficiency of both NOSE procedures

    The operation time defined as the incision of wound and application of the surgical dressing

    Time frame: Intraoperative hours with an average of 5 hours

Secondary outcomes

  1. Overall disease-free survival

    The duration between surgery and death

    Time frame: 5 years

  2. Overall recurrence-free survival

    The duration between surgery and recurrence

    Time frame: 5 years

  3. Incontinence

    Evaluated by questionnaire

    Time frame: 6 months

  4. Time to return work

    Disability

    Time frame: 1 year

  5. Total fee and equipment fee

    Total Cost

    Time frame: 3 months

  6. Blood loss

    measured by the amount Mof blood in suction bottle and the number of blood soaked gauzes

    Time frame: Intraoperative hours with an average of 5 years

  7. Conversion rate

    Conversion from robotic surgery to laparoscopic surgery or open surgery

    Time frame: Intraoperative hours with an average of 5 years

  8. Complications

    Any complication during or after surgery grading by Calvien -Dindo classification

    Time frame: 30 days

  9. Wound size

    Total length of the wounds

    Time frame: Intraoperative hours with an average of 5 years

  10. Serum C reactive protein (CRP)

    CRP could be an indicator of the severity of surgical stress.

    Time frame: Throughout the admission with an average of 7 days

  11. Erythrocyte sedimentation rate (ESR)

    ESR could be an indicator of the severity of surgical stress.

    Time frame: Throughout the admission with an average of 7 days

  12. Blood lymphocyte counts

    Blood lymphocyte counts could be an indicator of the severity of surgical stress.

    Time frame: Throughout the admission with an average of 7 days

  13. CD4+ to CD8+ ratio

    CD4 to CD8 ratio could be an indicator of the severity of surgical stress.

    Time frame: ESR could be an indicator of the severity of surgical stress.

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Apr 2025, 23 months after the start.

Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 23 months is below that.

Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2023
First posted
Aug 1, 2023
StartActual
Apr 7, 2023
Primary completionEst.
Apr 6, 2025
CompletionEst.
Oct 6, 2025
Last update
Sep 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05970133
Responsible party
Sponsor
First posted
Aug 1, 2023
Start date
Apr 7, 2023
Primary completion
Apr 6, 2025 (estimated)
Completion
Oct 6, 2025 (estimated)
Last update
Sep 20, 2024

Study contacts

Jin-Tung LIANG, MD
Contact
jintung@ntu.edu.tw
886-9-72651432
Jin-Tung LIANG, MD
study chair · National Taiwan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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