Transanal total mesorectal excision in treatment of mid-low rectal cancer: Double-team or single-team?

Hue Central Hospital Journal of Clinical Medicine - No. 62/2020 25 TRANSANAL TOTAL MESORECTAL EXCISION IN TREATMENT OF MID-LOW RECTAL CANCER: DOUBLE-TEAM OR SINGLE-TEAM? Ho Huu Thien1 DOI: 10.38103/jcmhch.2020.62.5 ABSTRACT Introduction: Transanal total mesorectal (TaTME) is an emerging surgical technique for mid-low rectal cancer. The technique has shown favorable results, but some TaTME related complications have also been published. Besides, the number of reports on the TaTME technique is quite large, but only several reports were done with two surgical teams simultaneously. This study investigated the effectiveness of the double-team TaTME on the short-term morbidity and the quality of mesorectal excision by comparing with the single- team TaTME. Materials and Methods: We included 50 patients (n=32 single-team TaTME, n=18 double-team TaTME) with mid-low rectal cancer. We analyzed the surgical results of patients treated for mid-low rectal cancer with single team TaTME or double team TaTME. The primary endpoints of this study were short-term morbidity and specimen outcome. Results: Patient characteristics and tumor characteristics were not significantly different between the single - team Ta TME and double - team Ta TME groups. Overall, the mean operative time was 204 minutes. The operative time was significantly shorter with a double - team TaTME (160 minutes) than with a single - team TaTME (230 minutes). In addition, there were no intraoperative events recorded in both groups. Three presacral abscesses complications (grade III) in the single-team and none in the double - team were documented. The difference was not significant between the two groups. The proportions of TME grade I, TME grade II, and TME grade III were not significantly different between the single - team and double- team groups. A positive circumferential resection margin (CRM) was not significantly different between the single - team (3, 9.3%) and the double-team groups (1,5.5%). There was not any significant difference in local recurrence and DFS between the two groups. Conclusion: The double-team TaTME in treatment of mid-low rectal cancer is effective with shortness of operative time, none postoperative presacral abscess recorded, and the quality of mesorectal excision guaranteed. Keywords: transanal total mesorectal excision, rectal cancer, double - team. 1. Hue Central Hospital Corresponding author: Ho Huu Thien Email: thientrangduc@hotmail.com Received: 8/5/2020; Revised: 17/5/2020 Accepted: 20/6/2020 I. INTRODUCTION Rectal cancer is one of the most common types of cancer worldwide, with an annual incidence of approximately 40,000 new cases diagnosed in the Bệnh viện Trung ương Huế 26 Journal of Clinical Medicine - No. 62/2020 United States alone [1]. Total mesorectal excision (TME) was first described by Heald et al. in 1982 and since then has been considered the gold standard for the surgical treatment of rectal cancer [2]. However, mid and low rectal cancer is associated with the worse outcome compared to high rectal cancer due to the difficult access of the lower pelvis in both open TME and laparoscopic TME. Mainly, low rectal cancer surgery, relative higher rates of incomplete specimens, and higher rates of CRM involvement have been reported compared to tumors located in the upper rectum [3] [12]. Transanal total mesorectal excision (TaTME) has grown in popularity, reflected by the rising number of scientific publications since its introduction in 2010 by the group of Lacy [13] . Early adaptors of the technique have shown favorable results, but some TaTME related complications have also been published [13] [17]. Also, increased bacterial load, as is observed after TaTME might induce the occurrence of presacral abscesses [18] [19]. Besides, the Ta TME technique can perform two surgical teams simultaneously [20], so the time for the overall procedure, especially the time for the distal rectal stump to remain in the pelvis, may be shortened, theoretically hoping to reduce this complication. Therefore, this study investigated the effectiveness of the double - team TaTME on the short - term morbidity and specimen outcomes by comparing with the single - team TaTME. II. MATERIALS AND METHODS We retrospectively retrieved data from patient’s medical records of Hue Central Hospital, a 3000- bed cancer referral center in the central region of Vietnam. The hospital’s ethics committee approved the study (IRB number HCH-06122019). We analyzed the surgical results of patients treated for mid-low rectal cancer with single team TaTME or double team TaTME. We adopted a single team TaTME technique in our hospital from March 2015, and we changed from a single team into a double team in March 2018. All patients in this study were operated by a surgical team who had the experience of NOTES technique since 2013 after training at ASIA IRCAD (Institute for Research into Digestive Cancers) in Taiwan. Therefore, the single- team TaTME group included patients treated with the single team TaTME between March 2015 and March 2018 and the double team TaTME between March 2018 and September 2019. The primary endpoints of this study were short- term morbidity and specimen outcome. We analyzed the patient’s demography, intraoperative events, operative duration, postoperative complications, quality of mesorectum specimens, and local and distant recurrence rates after a follow - up of 6 months. All patients were preoperatively diagnosed with low (3 - 6 cm from the anal verge) or mid (6 - 9 cm from the anal verge) rectal cancers based on pathology, MRI, abdominal CT, rectal endoscopic ultrasonography and clinical examination. Patients were treated with neoadjuvant/adjuvant therapy, according to the European Society for Medical Oncology guidelines [21] .The completeness of the mesorectum22 defined the quality of the TME specimen. Postoperative complications were graded according to the Clavien - Dindo classification [23]. Perioperative Management All patients underwent a mechanical bowel preparation the day before surgery and received antibiotics. Single team TaTME technique We started the procedure with abdominal laparoscopy in order to evaluate the peritoneal cavity and exclude distant metastases. Subsequently, with the patient in Trendelenburg’s position, a Lone Star® retractor (Cooper Surgical, Trumbull, Connecticut, USA) followed by a haemorrhoidectomy anal dilator (Covidien, Transanal total mesorectal excision in treatment... Hue Central Hospital Journal of Clinical Medicine - No. 62/2020 27 Minneapolis, Minnesota, USA) were placed, and a rectal wash with 10 percent povidone-iodine solution was performed. A purse - string suture was then used to close the rectal lumen 1 cm below the distal tumor margin using Prolene® 2.0 (Ethicon, Cornelia, Georgia, USA). The rectal lumen was sterilized again with 10 percent povidone-iodine, and the rectal wall was resected full-thickness, 1 cm lateral to the purse-string suture, starting at 6 o’clock, then proceeding to the entire circumference. A multiple - access SILS™ port (Covidien) was placed, and the TME dissection proceeded using traditional instruments and a harmonic scalpel up to the peritoneal fold. One abdominal gauze with 10 percent povidone - iodine was placed in the perineal space. The abdominal stage with the standard four-port technique was used, adding one 10 - mm (right lower quadrant) and two 5 - mm ports (right flank and left lower quadrant). We used a medial to lateral approach for high vessel ligation and splenic flexure mobilization. The abdominal stage finished when abdominal dissection met the transanal dissection. Double team TaTME technique The first step was a full laparoscopic mobilization of the splenic flexure with patients positioned in the reverse Trendelenburg position with the patient on tilted right 45. A standard four-port technique was used, including two 10-mm (umbilical and right lower quadrant) and two 5-mm ports (right flank and left lower quadrant). Subsequently, in the Trendelenburg position with the patient on tilted right 45, a laparoscopic medial to lateral dissection was continued for high ligation of the inferior mesenteric vessels, simultaneously with transanal TME. A Lone Star® retractor (CooperSurgical, Trumbull, Connecticut, USA) followed by a haemorrhoidectomy anal dilator (Covidien, Minneapolis, Minnesota, USA) was placed, and a rectal wash with 10 percent povidone- iodine solution was performed. A purse-string suture was then used to close the rectal lumen 1 cm below the distal tumor margin using Prolene® 2.0 (Ethicon, Cornelia, Georgia, USA). The rectal lumen was sterilized again with 10 percent povidone-iodine, and the rectal wall was resected full-thickness, 1 cm distal to the purse-string suture, starting at 6 o’clock, then proceeding to the entire circumference. Further dissection needed 1-2 Langenbecks retractors and 1-2 abdominal Malleable Spatula held by two assistants to see the dissection plane. Perineal dissection was conducted posteriorly and anteriorly up to the peritoneal fold. When we saw the light from the abdominal cavity, the perineal dissection stopped, and the abdominal team would complete the rectal resection. Laparoscopic TaTME was not used in this group. Specimen management In both groups, specimens with a tumor of 5 cm or less in diameter were usually extracted through the anus. In contrast, the extraction site was generally in the right lower quadrant (planned place of a temporary ileostomy) when the tumor measured more than 5 cm or for smaller tumors with bulky mesorectum or mesocolon. Finally, a coloanal end-to-end hand-sewn anastomosis and a protective ileostomy were created in all patients. Intestinal continuity was restored at 4 - 6 weeks or after completion of postoperative adjuvant therapy. Statistical analysis For descriptive analysis, the frequency or the mean and standard deviation were calculated for each variable. For other continuous variables, independent sample t-tests were applied to compare the data between the single - team group and the double-team group. Their respective p- values and corresponding confidence intervals were provided by SPSS Version 18.0 (SPSS Inc., Chicago, Illinois, USA). The statistical significance was set at p <0.05. Bệnh viện Trung ương Huế 28 Journal of Clinical Medicine - No. 62/2020 III. RESULTS 3.1. Patient characteristics Among the 50 patients studied (n=32 TaTME single team and n=18 TaTME double team), the male/female ratio was 2.25, the mean age was 59.4 ± years, and the mean BMI was 24.4± kg/m2. Overall, 44 (88%) patients received neoadjuvant treatment, including 30 (93.7%) in single-team TaTME and 14 (77.8%) in double team TaTME. Patient characteristics were not significantly different between the single - team Ta TME and double - team Ta TME groups. (Table1). Table 1: Patient characteristics Patient’s demography All (n=50) Single - team (n= 32) Double - team (n= 18) p - value Age (year) 58.7 ± 15.3 58.4 ± 14.2 59.2 ± 17.2 1.00 BMI (kg/m2) 24.0 ± 2.3 23.8 ± 2.6 24.4 ± 1.8 1.00 Neo-adjuvant 44 (88%) 30(93.7%) 14 (77.8%) 0.10 We found a cTNM stage 1 in two (4%) patients, cTNM stage 2 in 18 (36%) patients, and cTNM stage 3 in 20 (40%) patients, with no significant difference between the groups. We also noted that the tumors’ position of single team TaTME group was comparable with those of the double team TaTME group.The details were in table 2 Table 2: Tumor characteristics Tumor characteristics All (n=50) Single - team (n= 32) Double - team (n= 18) p - value Tumor position Mid 31 (62.0%) 20 (62.5%) 11 (61.1%) 0.92 Low 19 (38.0%) 12 (37.5%) 7 (38.9%) 0.92 cTNM- stage I 2 (4.0%) 2 (6.3%) 0 (0%) 0.28 II 18 (36.0%) 10(31.3%) 8 (44.4%) 0.35 III 30 (60.0%) 20 (62.5%) 10 (55.6%) 0.63 3.2. Peri - operative characteristics Overall, the mean operative time was 204 minutes. The operative time was significantly shorter with a double - team TaTME (160 minutes) than with a single - team TaTME (230 minutes). In addition, there were no intraoperative events recorded in both groups. Postoperative outcomes of the two groups are shown in table 3. Each group had one patient with difficulty in voiding (grade II) with no significant difference. Three presacral abscesses complications (grade III) in the single - team and none in the double - team were documented. The difference was not significant between the two groups. Continence was classified as grade I in all patients at three months after ileostomy closure. Transanal total mesorectal excision in treatment... Hue Central Hospital Journal of Clinical Medicine - No. 62/2020 29 Table 3: Peri-operative characteristics Peri - operative characteristics All (n=50) Single team (n= 32) Double - team (n= 18) p - value Operative time (minutes) 204 ± 51 230 ± 55 160 ± 45 <0.0001 Intraoperative events 0 0 0 Presacral abscess n (%) 3 (6.0%) * 3 (9.4%) 0 (0%) 0.18 Voiding difficulty n (%) 2 (4.0%) ** 1 (3.1%) 1 (5.5%) 0.67 *Clavien-Dindo grade III ** Clavien-Dindo grade II 3.3. Pathological characteristics Of the 50 patients, 45 (90%) had TME grade I, and 5 (10%) had TME grade II. TME grade I was present in 29 (90.6%) in single-team and 16 (88.9%) in double-team. The proportions of TME grade I, TME grade II, and TME grade III were not significantly different between the single-team and double- team groups. A positive circumferential resection margin (CRM) was not significantly different between the single-team (3, 9.3%) and the double-team groups (1, 5.5%) (Table 4). Table 4: Pathology characteristics Pathology characteristics All (n=50) Single team (n= 32) Double team (n= 18) p - value CRM positive 3 (6%) 3 (9.4%) 1 (5.6%) 0.63 DRM positive 0 0 0 TME grade I 45 (90.0%) 29 (90.6%) 16 (88.9%) 0.84 II 05 (10.0%) 03 (9.4%) 02 (11.1%) 0.84 III 0 0 0 3.4. Follow - up The patients with local recurrence were noted one patient in the single-team TaTME group and none in the double-team group. The disease-free survival (DFS) rates with the follow-up of six months were 96.8% and 100% in the single - team and double - team, respectively. There was not any significant difference in local recurrence and DFS between the two groups. VI. DISCUSSION Many reports on the TaTME technique were published, but only about nine reports were done with two surgical teams simultaneously, of which only 2 - 3 reports have all patients underwent by this technique [24] [25]. This fact suggests that the majority of authors are afraid of this method due to its complexity [26]. Indeed, TaTME is usually performed in patients with low-middle rectal cancer, which always requires the release of the splenic flexure [27]. The convenient position for this phase is the reverse Trendelenburg, with the patient inclined to the right. With the double team technique, the patient is required to be in a convenient position for both the abdominal and the perineal team, usually the Trendelenburg position, with the patient inclined to the right and placed in modified lithotomy. In this position, the perineal team is at a disadvantage because the patient’s axis Bệnh viện Trung ương Huế 30 Journal of Clinical Medicine - No. 62/2020 is no longer horizontal, but to the right about 45. In addition, the insufflation of both the epithelium and perineum simultaneously makes the dissections affected, especially the perineal phase. To overcome the postural obstacle, we firstly left the patient in a reverse Trendelenburg position to conduct the release told ligament and splenic flexure. The patient was then reset to the right inclined Trendelenburg position. The abdominal and perineal phases are carried out simultaneously from this time. We used the open TaTME technique for the perineal phase. This technique helps avoid the perineal insufflation making it does not interfere with the abdominal phase. Also, the duration of the open Ta TME was short because it does not take time to place the endoscopic instrument. Two surgical teams usually Rendez-Vous a little below the peritoneal fold. With the open Ta TME technique, the mesorectum is considered almost complete when it reaches this level [26]. Besides, the open perineal TaTME technique gives us a chance to use the fingers to identify the urethra or vagina wall that helps avoid TaTME related complications [13] [17]. A disadvantage for the open perineal TME phase is that the patient’s axis is no longer horizontal but tilted to about 45, and the patient’s anus is relatively low, thus requiring the perineal team to have experience in this phase. We always sectioned the mesentery along the inferior mesenteric artery to the wall of the colon, ensuring the removal of lymph nodes along the inferior mesenteric artery if the tumor is pulled through the anus. With this tactic, our operative time was significantly reduced from 230 minutes to 160 minutes. The shortness of operative time was also reported in the study of Cassinoti E [27] and Fernández - Hevia M [28]. when TaTME was performed using a two-team approach simultaneously. Besides, in a systemic review of Deijen, for studies reporting on TaTME with two teams, the weighted mean for the operative time was 209.8 min (range 166 - 369) compared to 264.5 min (range 204 - 360) with one operating team [25]. Does double - team TaTME affect the quality of mesorectal excision? The studies of the authors performing double team TaTME all showed that the quality of TME is guaranteed [20] [28] [30]. Our research with open perineal TME technique also showed that the quality of TME was guaranteed to be the same as two separate phases (Table 4). We routinely carried out a rectal washout with povidone-iodine just before and after the rectal purse - string, but we still had three presacral abscess in single - team group. Otherwise, we did not record any presacral abscess in the double-team group. However, the difference was not significant between the two groups (p=0.18) (Table 3). A rectal incision can theoretically create a contaminated field that raised initial concerns for higher pelvic abscess rates. Indeed, Velthuis et al. found a positive pelvic culture in 39% of patients using the TaTME technique18. Also, Deijen et al. reported a pelvic abscess in 18 of 794 patients (2.3%) [24], and Wolthuis et al. reported a rate of 3.4%, including 20 studies and 323 patients [25] in their systematic review. A nearly similar rate of 2.4% (17/720) was reported from the international TaTME registry [31]. Our follow - up is far from ideal, but the early results of this method suggest that this is an effective method regarding the oncologic aspect. The recurrence rate in the double - team group is similar to that of the single - team group. The disease-free survival (DFS) rates of six-month follow-up were 96.8% and 100% in the single - and double - team, respectively. In the most recent systematic review by Deijen et al., only 5 of 33 studies (including 302 patients) reported a follow-up of more than 12 months. The overall time of follow - up was 18.9 months. The local and distant recurrence rates were 4% and 8.1%, respectively [25]. 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Transanal total mesorectal excision in treatment...