General Information:
A retrospective analysis was conducted based on data from 6 rectal cancer patients who underwent Ta_tme using a degradable colorectal endoluminal stent with extension sleeve at the general surgery department of our hospital from August 2023 to September 2023. The cohort included 4 males and 2 females, with an average age of 64.0 ± 5.8 years (range: 53-70 years). Preoperative colonoscopy biopsy confirmed rectal cancer in all cases, with tumors located less than 5cm from the anus and deemed suitable for sphincter preservation based on preliminary examinations. Routine chest CT, abdominal CT with contrast enhancement, and liver MRI were performed to exclude distant metastases in the chest and abdomen. All patients were at high risk for anastomotic leakage post-Ta_tme: According to the AJCC guidelines, 4 patients underwent neoadjuvant chemoradiotherapy preoperatively, and 1 patient had comorbidities including hypertension, coronary heart disease, coronary stent implantation, and diabetes. All underwent Ta_tme surgery at our hospital, with intraoperative placement of the biodegradable stent with extension sleeve. No conversion to open abdomen surgery or other fecal diversion methods were used.( We confirm that all methods were performed in accordance with the relevant guidelines and regulations by including a statement in the methods section to this effect.) Clinical data of these patients are shown in Table 1.
Table 1: Clinical Data of the 6 Patients Undergoing Laparoscopic Assisted Radical Resection of Rectal Cancer with Stent Method for Intestinal Diversion
Case No.
|
1
|
2
|
3
|
4
|
5
|
6
|
Gender
|
Female
|
Male
|
Female
|
Male
|
Female
|
Male
|
Age
|
69
|
53
|
64
|
70
|
54
|
60
|
BMI
|
22.2
|
24.7
|
20.2
|
29.2
|
19.2
|
28.4
|
History of diseases
|
None
|
Hypertension
|
None
|
Hypertension, coronary heart disease, coronary stent implantation
|
Hypertension
|
Lung cancer
|
Operative Time (min)
|
215
|
335
|
195
|
280
|
225
|
265
|
Intraoperative Blood Loss (ml)
|
100
|
50
|
200
|
100
|
200
|
400
|
Tumor location and size(cm)
|
Distance from Tumor to Anal Margin (cm)
|
3
|
4
|
6
|
4
|
4
|
4
|
Largest Tumor Diameter (cm)
|
1
|
3
|
3
|
3
|
1.5
|
4
|
Distance from Anastomosis to Anal Margin (cm)
|
1
|
2
|
3
|
2
|
2
|
2
|
Time to Stoma Closure (days)
|
27
|
27
|
19
|
24
|
24
|
24
|
Hospital Stay (days)
|
11
|
18
|
14
|
18
|
15
|
19
|
Postoperative Adjuvant Chemotherapy
|
Done
|
Not done
|
Done
|
Not done
|
Done
|
Done
|
Pathological Stage
|
T2N1M0
|
T1N0M0
|
T2N0M0
|
T1N0M0
|
T0N0M0
|
T2N3M0
|
Study Methods: This study was approved by the Medical Ethics Committee of our hospital (Approval number: Device Clinical Trial 158-02). All patients voluntarily chose Ta_tme surgery with the insertion of the biodegradable stent with extension sleeve.
(I) Indications and Contraindications
1. Indications:
(1) Pathologically confirmed primary solitary rectal cancer without distant metastases;
(2) Planned Ta_tme procedure;
(3) Age between 18-80 years, regardless of gender;
(4) Nutritional risk screening score ≤2 points;
(5) Subjects voluntarily participate in this clinical study and sign an informed consent form for the surgery.
2. Contraindications:
(1) History of rectal surgery;
(2) Familial adenomatous polyposis, hereditary non-polyposis colorectal cancer;
(3) Active Crohn's disease or active ulcerative colitis;
(4) Acute cardiovascular or cerebrovascular events within the past 6 months (e.g., unstable angina, acute myocardial infarction);
(5) Continuous use of corticosteroids within the past month;
(6) Pregnant or planning to become pregnant women, breastfeeding women;
(7) Severe mental disorders;
(8) Severe complications that cannot tolerate surgery or require emergency surgery;
(9) Discovery of multiple rectal tumors, distant metastases, or inability to achieve R0 resection during surgery;
(10) Not undergoing laparoscopic anterior resection of rectal cancer due to conversion to open surgery or other surgical methods.
(II) Surgical Method
The surgeries for all six low rectal cancer patients were completed by the same medical team.
Under general anesthesia with endotracheal intubation, the patients were positioned in the lithotomy position.
Abdominal operation:
Five trocars are placed above the umbilicus, to the left and right of the umbilicus, in the left upper abdomen, and in the right lower abdomen. Under laparoscopy, following the TME principle, the peritoneum on the right side of the inferior mesenteric vessel root was incised, the inferior mesenteric artery and vein were mobilized, ligated with absorbable clips, and divided with an ultrasonic scalpel. The rectum was mobilized to the peritoneal reflection and adequately freed to the plane of the levator ani muscle.
Transanal operation:
Depending on the tumor's location, the following steps were taken: A port was implanted transanally, and the abdomen was insufflated to a pressure of 12mmHg using an insufflator (manufacturer: ConMed, USA, model: AS-iFS2). A, for tumors 3-5cm from the dentate line, purse-string sutures were placed under direct vision, followed by the placement of the operating platform; B, for tumors 1-3cm from the dentate line, purse-string sutures were first placed under direct vision, then 1cm distal to the purse-string, the anal canal was then incised, the intersphincteric space was dissected, and finally, the operating platform was placed. Withe the help of laparoscopy, the resection margin was circumferentially marked 1cm proximal to the purse-string suture site, and the mucosal layer, submucosal layer, and muscular layers (inner circular and outer longitudinal) were sequentially incised using an electrotome or ultrasonic scalpel. The Ta_tme procedure progresses upwards through four anatomical spaces: A, the intersphincteric space; B, the suprapubic space; C, Denonvilliers' fascia space; D, the presacral space. Finally, the abdominal and transanal teams converged, completely mobilizing the rectum and tumor.
Specimen Extraction:
After adequately mobilizing the mesentery of the sigmoid colon and the proximal colon, the transanal operating platform was retracted. A protective sleeve was inserted into the incision, and the mobilized bowel was pulled out through the anus. Whether the specimen is extracted transanally or transabdominally, it is essential to trim the mesentery according to the principles of radical rectal cancer surgery, transecting the bowel at least 10cm proximal to the tumor lesion, and cleaning the pelvic and abdominal cavity.
Implantation of the Stent with Extension Sleeved :
Biodegradable Stent (Batch number: Device Clinical Trial 20190903-15)
The inner diameter of the proximal bowel was measured with a columnar ruler (as shown in Figure 1). A suitable-sized stent was chosen and connected to a sterile extension sleeve (as shown in Figure 2). The biodegradable stent was placed inside the proximal bowel 5cm from the cut edge (as shown in Figure 3). Using absorbable sutures, the stent was fixed at the predetermined position in the bowel through the mesorectum from outside the bowel lumen (as shown in Figure 4), ensuring proper tension. The proximal bowel was then pushed back into the pelvis through the anus.
Reconstruction of Digestive Tract :
If the distal rectal incision is more than 2cm from the dentate line, the digestive tract can be reconstructed using a stapler. The procedures is as follows. The anvil head is placed in the proximal bowel, and after completing a full-thickness purse-string suture at the anal side, the purse-string is tightened around the central rod of the anvil head, which has been reintroduced into the pelvis. After ensuring there is no torsion in the bowel, the stapler is docked with the external central rod to complete an end-to-end anastomosis, and the incision should be inspected. If the anastomosis is within 2cm of the dentate line, a continuous full-thickness end-to-end manual anastomosis is performed under direct vision using 3/0 absorbable suture (as shown in Figure 5).
Sterile Plastic Sleeve Extraction:
The sterile protective sleeve was passed around the anastomosis and extracted through the anus (as shown in Figure 6). The distal end of the sterile protective sleeve was then cut (as shown in Figure 7), and the surgery was completed.
(III) Postoperative Care and Follow-up Methods
Postoperatively, patients were fed a semi-liquid, low-residue diet. The quantity and nature of the output from the diversion tube were monitored daily, along with the patient's temperature, abdominal signs, and routine blood tests. Follow-ups were scheduled for the 14th, 21st, 28th days postoperatively and one month after tube removal. In addition to routine blood and biochemical parameters, the drainage tube was removed between 7-9 days postoperatively if there are no abnormal findings such as anastomotic leakage. No patients experienced complications such as anastomotic stricture or leakage. If postoperative pathological examination reveals lymph node metastasis or high-risk factors for recurrence, adjuvant chemotherapy is administered. Postoperative anastomotic status was checked monthly, with regular follow-ups every three months for postoperative rectal cancer.
III. Statistical Methods
Quantitative data with a normal distribution are presented as mean ± standard deviation (x±s), and categorical data are expressed as frequency and percentage.