The Chang Gung Medical Foundation Institutional Review Board approved this study (IRB No. 202301006B0). We collected and analyzed the data of 1162 rectal cancer patients who underwent surgery at the Division of Colorectal Surgery, Chang Gung Memorial Hospital, Linkou, from January 1, 2016, to December 31, 2020 (Fig. 1). Before the surgery, we performed preoperative evaluations such as colonoscopy, chest-pelvis computed tomography, pelvic magnetic resonance imaging (MRI), rectal sonography (if needed), and essential laboratory tests (including serum carcinoembryonic antigen). We also prospectively recorded each patient’s clinical characteristics, such as age, sex, comorbidities (cardiovascular disease, cirrhosis, etc.), tumor location, and the neoadjuvant chemoradiation regimens.
The surgeon decided whether to use neoadjuvant concurrent chemoradiation (CCRT) or short-course radiotherapy for patients with locally advanced rectal cancer (cT3, cT4, or positive cN stage). Patients receiving neoadjuvant CCRT had a 5-fluoropyrimidine-based regimen (5-fluorouracil, capecitabine, or tegafur) and 50.4 Gy of radiotherapy in 28 fractions. They had surgery 6 to 8 weeks after finishing the therapy. Patients with short-course radiotherapy got a dose of 25 Gy in 5 fractions to the pelvis and tumor. They had surgery 8 to 10 days after radiotherapy or additional 5-fluoropyrimidine-based neoadjuvant chemotherapy before the surgery. The surgeon chose a 5-fluoropyrimidine-based regimen (5-fluorouracil, capecitabine, or tegafur) for the adjuvant chemotherapy. Whether to give oxaliplatin to the patient is based on each surgeon’s decision.
All of the robotic device used in this study was the Da Vinci® Xi surgical system (Intuitive Surgical, Sunnyvale, CA, USA), and we used 4 robotic arms and one assistant arm in all of the robotics-assisted surgery. The anastomotic methods in this study were the ILS curved 29-mm intraluminal stapler (CDH 29, Ethicon Endo-Surgery) with or without hand-sewn reinforcement or coloanal hand-sewn anastomosis, each surgeon determined the choice of anastomosis during the surgery. The cartridges were used for transactions on the distal side of the rectum. Additional firing would be applied if the transaction was incomplete with one cartridge. The common reasons for multiple firings were the narrow pelvis, inability to visualize the cartridge application, limited angle for applying the cartridges, and the number of cartridge firings strongly associated with anastomotic leakage.[9] We used ECHELON FLEX™ ENDOPATH® Staplers (Ethicon, Johnson & Johnson, New Brunswick, NJ) with 60 mm or 45 mm green cartridges in both the robotic-assisted and laparoscopy groups. Each surgeon determined the size of the cartridge intraoperatively. After the anastomosis, we routinely performed air-leak tests. If air leakage was detected, we would add an additional suture and re-perform the test. A re-anastomosis and preventive stoma would be performed if the air leakage was still persisted. The surgeons in our center usually create a preventive stoma in patients with lower rectal cancer, narrow pelvic cavity, those who received neoadjuvant radiotherapy, and malnutrition status.[10–13] However, the final decision depended on each surgeon during the surgery.
The anastomotic leakage was diagnosed clinically and radiologically as one of the following: diffuse peritoneal signs, gross fecal content from the wound or the drainage tube, pelvic abscess with fever and sepsis, pus-like discharge from anus and rectovaginal fistula. Although most patients had radiological tests when leakage was suspected, some patients with diffuse peritonitis after intestinal resection with anastomosis underwent immediate exploratory laparotomy. Once the leakage occurred, our first attempt was laparoscopic exploration for fecal diversion and drainage. However, we would opt for laparotomy exploration in patients with unstable hemodynamic status, which made them unsuitable for laparoscopic exploration. We also recorded other complications, such as surgical wound infections, postoperative ileus, and genitourinary system involvement. Postoperative ileus was defined after ruling out anastomotic leakage clinically and radiologically.
After the surgery, we documented the pathological stage, cancer histology, length of hospital stay, stoma status, and complications. We followed a standardized protocol to arrange postoperative follow-up. "Local recurrence" refers to the reappearance of cancer in the pelvic region following surgery. On the other hand, "distal metastasis" is characterized by the recurrence of cancer beyond the pelvic area, such as in the liver, lungs, or other lymph nodes. Before closing the stoma, a digital rectal examination was conducted to assess the connection between the two ends of the intestine and to examine for any infection near the anus. An extra colonoscopy or lower gastrointestinal series was performed when the digital rectal examination results were inconclusive.
We compared patients who had laparoscopy anterior resection and robot-assisted anterior resection. We did not include patients with Transanal Total Mesorectal Excision or laparotomy surgery. We also excluded patients with a non-curative resection, metastatic disease, recurrent cancer, emergency surgery, or non-adenocarcinoma types such as sarcoma, melanoma, and gastrointestinal stromal tumor. We excluded patients with upper rectal cancer (> 10 cm from the anal verge) because they had a low chance of anastomosis leakage and stoma creation. We also omitted patients who had abdominoperineal resection or Hartmann’s procedure because they did not have anastomosis and had immediate permanent stoma after the surgery. The permanent stomas included stomas that were not closed or reopened. The stomas that were not closed were those that did not have a reversal procedure until the end of the follow-up period. Stomas reopened, had a recreation procedure after a previous closure, and remained open until the end of the follow-up.
We performed statistical analysis using SPSS statistics software (version 24.0; SPSS Inc., Chicago, IL, USA). We compared continuous variables between the groups using an independent samples t-test and categorical variables using a chi-square or Fisher’s exact test. We calculated the survival curve between the groups by Kaplan–Meier analysis and used the log-rank test to compare it. We used multivariate logistic regression to identify the independent factors predicting permanent stoma. The p-value < 0.05 is considered statistically significant.