Trial Title:
Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer
NCT ID:
NCT05970133
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Natural orifice specimen extraction
Laparoscopic surgery
Robotic surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Colectomy with NOSE procedure
Description:
The specimen will be extract from the anus.
Arm group label:
Laparoscopic surgery
Arm group label:
Robotic surgery
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.
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.
Criteria for eligibility:
Criteria:
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jin-Tung LIANG, MD
Phone:
886-9-72651432
Email:
jintung@ntu.edu.tw
Start date:
April 7, 2023
Completion date:
October 6, 2025
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970133
