TECHNICAL NOTE
Robotic-Assisted Laparoscopic Transanal Total Mesorectal Excision for Rectal Cancer: A Prospective Pilot Study Marcos Gómez Ruiz, M.D. • Ignacio Martín Parra, M.D. • Carlos Manuel Palazuelos, M.D. Joaquin Alonso Martín, M.D. • Carmen Cagigas Fernández, M.D., Ph.D. Julio Castillo Diego, M.D., Ph.D., E.S.B.Q • Manuel Gómez Fleitas, M.D., Ph.D. Department of Surgery, Hospital Universitario Marqués de Valdecilla, Secretaría de Cirugía General y Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Santander, Spain
BACKGROUND: We performed a prospective pilot study of robotic-assisted laparoscopic transanal proctectomy with total mesorectal excision for the surgical treatment of rectal cancer. This study was to assess the feasibility and safety of robotic-assisted laparoscopic transanal total mesorectal excision. TECHNIQUE: All patients underwent robotic-assisted laparoscopic left colon mobilization, robotic-assisted laparoscopic transanal total mesorectal excision, ultralow mechanical colorectal or handsewn coloanal anastomosis, and a diverting loop ileostomy. Four patients with stage III disease received long-course preoperative chemoradiation before surgery. MAIN OUTCOME MEASURES: Primary and secondary end points included the assessment of pathological examination and postoperative morbidity. Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.dcrjournal.com). Funding/Support: The pilot study was supported by the Department of Surgery, Hospital Universitario Marqués de Valdecilla. Intuitive Surgical Inc. provided robotic instrumentation instruments for certain procedures.
RESULTS: Between August 2013 and January 2014, 4 men and 1 woman underwent robotic-assisted laparoscopic transanal total mesorectal excision. Patient age and BMI were 57 ± 13.9 years and 25.8 ± 2,7 kg/m2. Tumors were located an average of 5 ± 1 cm from the anal verge and were preoperatively staged as T2N0M0 (1 patient) and T2N1M0 (4 patients). Mean operative time was 398 ± 88 minutes with no intraoperative complications. Mean length of hospital stay was 6 ± 1 days. A Clavien II, grade B anastomotic leakage developed in 1 patient postoperatively. In all cases, pathological examination of the total mesorectal excision specimens showed complete mesorectal excision with negative proximal, distal, and circumferential margins. All patients were disease-free at their initial 3-month follow-up. CONCLUSIONS: Robotic-assisted laparoscopic transanal total mesorectal excision is a feasible and safe option for the surgical management of early-stage rectal cancers. Robotic technology with endowristed instruments and 3-dimensional high-definition imaging are of great help in overcoming the limitations of traditional laparoscopic transanal surgery. Long-term functional and oncological assessments of outcome are needed.
Financial Disclosures: Dr Gómez Ruiz has been a proctor for Intuitive Surgical Inc. since 2013. Dr Alonso Martín has been a proctor for Intuitive Surgical Inc. since 2013. Intuitive Surgical Inc. provided robotic instrumentation used for certain procedures.
KEY WORDS: Rectal cancer; Total mesorectal excision; Robotic surgery; Transanal surgery; Laparoscopy; Natural orifice transluminal endoscopic surgery.
Correspondence: Marcos Gómez Ruiz, M.D., Secretaría de Cirugía General y Aparato Digestivo Pabellón 19 Bajo, Hospital Universitario Marqués de Valdecilla Av. Valdecilla s/n 39008, Santander, Spain. E-mail: [email protected]
ince 1982, total mesorectal excision (TME) combined with perioperative radiotherapy has been shown to be the only curative treatment for locally advanced rectal cancer.1–4 Total mesorectal excision is technically demanding and is usually performed as an open transabdominal operation. Since the introduction of laparoscopic resection techniques, the adoption rate
Dis Colon Rectum 2015; 58: 145–153 DOI: 10.1097/DCR.0000000000000265 © The ASCRS 2014 Diseases of the Colon & Rectum Volume 58: 1 (2015)
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145
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GÓMEZ RUIZ ET AL: ROBOTIC-ASSISTED LAPAROSCOPIC TRANSANAL TME
Figure 1. Abdominal robotic docking diagram.
of this approach has remained low with high rates of conversion to open laparotomy because of the unique challenges of laparoscopic pelvic dissection.5–7 Recently, several multicenter studies have compared the laparoscopic versus the open approach for rectal cancer treatment finding short-term advantages to laparoscopic surgery but similar oncological results.8,9 Now, some institutions with extensive experience in robotic rectal surgery have published comparative studies between open, laparoscopic, and robotic approaches showing advantages in the robotic group.10 Natural orifice transluminal endoscopic surgery with laparoscopic assistance has been
recently reported in a short series of cases to be feasible with adequate postoperative and anatomopathological results.11–16 Atallah et al17,18 have demonstrated the feasibility of transanal robotic proctectomy. Our group has recently reported on a preclinical cadaveric study19 and a case report20 of robotic-assisted laparoscopic transanal proctectomy with TME, demonstrating that the technique was feasible in a cadaveric model and in a male patient with a BMI of 31 kg/m2. The primary end point of the study was to determine the oncological adequacy of the TME specimen, and secondary end points were to examine short-term perioperative outcomes.
PATIENTS AND METHODS The protocol was approved by the Region of Cantabria (Spain) Research and Ethic Review Board (CEIC Approval code 2013.009). Protocol
Figure 2. Abdominal robotic docking.
Patients attending the outpatient surgery clinic with biopsy-proven adenocarcinoma of the rectum underwent tumor staging with standard protocol (ultrasound, MR of the pelvis, CT, and CEA levels). Eligible patients included men and women 18 years of age and older with clinically staged T2 or T3, N0 or N1, a predicted mesorectal circumferential margin of 5 mm or more on pelvic MRI, and no evidence of metastasis. Patients with T2N1 or T3N0/T3N1 tumors underwent
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Diseases of the Colon & Rectum Volume 58: 1 (2015)
Figure 3. Partial intersphincteric resection and insufflation of pelvic space steps.
standard preoperative chemoradiation (CRT) with 50.4 Gy and capecitabine for 6 weeks, followed by surgical resection 8 weeks later and the completion of 4 months of postoperative chemotherapy with 5-fluorouracil, leucovorin, and oxaliplatin before ileostomy closure. Additional eligibility criteria included tumors located 3 to 10 cm from the anal verge and 1 cm from the anorectal ring as found by proctoscopy. Patients were excluded if they were older than 70 years, clinically staged T4 or N2, had synchronous colorectal adenocarcinomas, previous colorectal malignancy, extensive previous abdominal or pelvic surgery, or fecal incontinence. Patients not suitable for laparoscopy because of cardiovascular or pulmonary diseases were also excluded. High BMI was not considered an exclusion criterion.
Figure 4. Transanal access port.
A CT scan was performed before discharge in all patients to assess fluid collections in the pelvis after this new approach. Procedure (Video)
With the patient under general anesthesia, a urinary catheter was inserted, and the patient was placed in the lithotomy position with the use of stirrups (see Video, Supplemental Digital Content 1, http://links.lww.com/ DCR/A166). Digital examination and rigid proctoscopy were performed to confirm the tumor location. A Veress needle was inserted in the left upper quadrant and the abdomen was insufflated with CO2 to an average pressure of 12 mmHg. Trocars were inserted in the right upper quadrant (12–15 mm and 8 mm), right lower quadrant (two 8-mm trocars), and periumbilical region (12–15 mm). The patient was positioned in a right tilt, and the peritoneal cavity was first inspected through a standard laparoscope. After confirming the absence of significant intra-abdominal adhesions and no evidence of distal tumor extension, a daVinci Si system (Intuitive Surgical Inc, Sunnyvale, CA) with instruments and accessories was docked from the patient’s left side (Figs. 1 and 2). Monopolar curved scissors were placed in arm 1, a fenestrated bipolar grasper was placed in arm 2, and a double-fenestrated grasper was used in arm 3 (see Fig. 2). A 30° 12-mm endoscope was used. The splenic flexure was taken down with dissection and division of the inferior mesenteric vein and artery at their root. The descending and sigmoid colon were mobilized, finishing the dissection at the sacral promontory. The da Vinci system was undocked, and the patient was repositioned
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GÓMEZ RUIZ ET AL: ROBOTIC-ASSISTED LAPAROSCOPIC TRANSANAL TME
Figure 5. Transanal robotic docking diagram.
in the Trendelenburg position with a slight right tilt for the next phase of the operation. Partial intersphincteric resection was performed for tumors located at 3 cm from the anal verge. A Lone Star retractor (Lone Star Medical Products Inc, Houston, TX) or a PPH anoscope (Ethicon Endosurgery, Cincinnati, OH) was positioned, and the mucosa and internal sphincter muscle were dissected circumferentially beginning at least 1 cm below the distal margin of the tumor. Intersphincteric dissection was extended
Figure 6. Transanal robotic docking.
cephalad for a distance of 1 to 2 cm, and a pursestring suture was placed to occlude the rectum below the tumor (Fig. 3). Following rectal occlusion, a “Transanal Access Port” proctoscope (PAT, Developia-HUMV, Santander, Spain) (Fig. 4) was inserted transanally, and a GelPoint (Applied Medical Inc, Rancho Santa Margarita, CA) was used to occlude the proctoscope and for trocar placement. A 12-mm or an 8.5-mm trocar was used for the optical port. Two 8-mm trocar ports were inserted with a distance of at least 4 cm for robotic instruments, and an accessory 12-mm trocar was inserted for the assistant port. The da Vinci Patient Cart was then docked over the left hip of the patient (Figs. 5 and 6). The fenestrated bipolar grasper was placed in arm 1 on the left, monopolar scissors were placed in arm 2 on the right, and a 30° endoscope was placed through the 12-mm trocar. The assistant trocar was used primarily to aid in tissue countertraction or to apply suction or irrigation. When partial intersphincteric resection had not previously been done (patients with tumors located higher than 3 cm from anal verge), the rectum was insufflated with CO2 to a pressure of 8 to 10 mmHg. The rectal mucosa was then scored circumferentially with monopolar cautery beginning distal to the pursestring and followed by full-thickness rectal dissection. After rectal wall division, the pelvic space around the remnant anal canal was insufflated to facilitate pelvic dissection and TME (Fig. 3). Anteriorly, the rectum was dissected from the posterior vagina or prostate following Denonvilliers fascia until the peritoneal reflection was reached and divided. Posterior and lateral mesorectal dissection was performed by using a transanal approach with laparoscopic assistance.
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Diseases of the Colon & Rectum Volume 58: 1 (2015)
Table 1. Patient demographics
Sex
Age, y
BMI, kg/m2
Male Male Female Male Male
55 57 38 67 46
26 31 25 26 22
Patient P01 P02 P03 P04 P05
Comorbidities
Previous abdominal surgeries
ASA
No BPH, Diab, DLP, OSAS No BPH, prostate tumor No
No No No No No
I II II II I
Wexner score 0 1 0 0 0
Soiling No No No No No
Charlson score POSSUM P-POSSUM CR-POSSUM 3.5 5.7 1.7 5.7 2.6
17 17 16 14 12
12 13 12 12 12
12 12 12 8 8
BPH = benign prostatic hypertrophy; Diab = diabetes mellitus; DLP = dyslipidemia; OSAS = obstructive sleep apnea syndrome.
Following adequate colonic mobilization, the rectum was grasped and exteriorized transanally under laparoscopic visualization through a small Alexis Wound Retractor (Applied Medical Inc, Rancho Santa Margarita, CA). A handsewn end-to-end coloanal anastomosis or mechanical end-to-end colorectal anastomosis was performed. A diverting loop ileostomy was created, and a pelvic drain was placed intra-abdominally in all cases. Postoperatively, patients were discharged home when they could tolerate a soft solid diet with a functioning stoma. All vital signs were stable during the hospital stay. All catheters and drains were removed before discharge.
RESULTS From August 2013 to January 2014, 5 patients (4 male and 1 female) underwent robotic-assisted laparoscopic transanal TME. Patient demographics and tumor characteristics are summarized in Tables 1 and 2. Mean patient age and BMI were 57 ± 13.9 years and 25.8 ± 2.7 kg/m2. The mean Charlson Score was 4.25 ± 1.9. The mean POSSUM Score was 16.3 ± 3. Tumors were located in the lower rectum in all patients (
Robotic-Assisted Laparoscopic Transanal Total Mesorectal Excision for Rectal Cancer: A Prospective Pilot Study Marcos Gómez Ruiz, M.D. • Ignacio Martín Parra, M.D. • Carlos Manuel Palazuelos, M.D. Joaquin Alonso Martín, M.D. • Carmen Cagigas Fernández, M.D., Ph.D. Julio Castillo Diego, M.D., Ph.D., E.S.B.Q • Manuel Gómez Fleitas, M.D., Ph.D. Department of Surgery, Hospital Universitario Marqués de Valdecilla, Secretaría de Cirugía General y Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Santander, Spain
BACKGROUND: We performed a prospective pilot study of robotic-assisted laparoscopic transanal proctectomy with total mesorectal excision for the surgical treatment of rectal cancer. This study was to assess the feasibility and safety of robotic-assisted laparoscopic transanal total mesorectal excision. TECHNIQUE: All patients underwent robotic-assisted laparoscopic left colon mobilization, robotic-assisted laparoscopic transanal total mesorectal excision, ultralow mechanical colorectal or handsewn coloanal anastomosis, and a diverting loop ileostomy. Four patients with stage III disease received long-course preoperative chemoradiation before surgery. MAIN OUTCOME MEASURES: Primary and secondary end points included the assessment of pathological examination and postoperative morbidity. Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.dcrjournal.com). Funding/Support: The pilot study was supported by the Department of Surgery, Hospital Universitario Marqués de Valdecilla. Intuitive Surgical Inc. provided robotic instrumentation instruments for certain procedures.
RESULTS: Between August 2013 and January 2014, 4 men and 1 woman underwent robotic-assisted laparoscopic transanal total mesorectal excision. Patient age and BMI were 57 ± 13.9 years and 25.8 ± 2,7 kg/m2. Tumors were located an average of 5 ± 1 cm from the anal verge and were preoperatively staged as T2N0M0 (1 patient) and T2N1M0 (4 patients). Mean operative time was 398 ± 88 minutes with no intraoperative complications. Mean length of hospital stay was 6 ± 1 days. A Clavien II, grade B anastomotic leakage developed in 1 patient postoperatively. In all cases, pathological examination of the total mesorectal excision specimens showed complete mesorectal excision with negative proximal, distal, and circumferential margins. All patients were disease-free at their initial 3-month follow-up. CONCLUSIONS: Robotic-assisted laparoscopic transanal total mesorectal excision is a feasible and safe option for the surgical management of early-stage rectal cancers. Robotic technology with endowristed instruments and 3-dimensional high-definition imaging are of great help in overcoming the limitations of traditional laparoscopic transanal surgery. Long-term functional and oncological assessments of outcome are needed.
Financial Disclosures: Dr Gómez Ruiz has been a proctor for Intuitive Surgical Inc. since 2013. Dr Alonso Martín has been a proctor for Intuitive Surgical Inc. since 2013. Intuitive Surgical Inc. provided robotic instrumentation used for certain procedures.
KEY WORDS: Rectal cancer; Total mesorectal excision; Robotic surgery; Transanal surgery; Laparoscopy; Natural orifice transluminal endoscopic surgery.
Correspondence: Marcos Gómez Ruiz, M.D., Secretaría de Cirugía General y Aparato Digestivo Pabellón 19 Bajo, Hospital Universitario Marqués de Valdecilla Av. Valdecilla s/n 39008, Santander, Spain. E-mail: [email protected]
ince 1982, total mesorectal excision (TME) combined with perioperative radiotherapy has been shown to be the only curative treatment for locally advanced rectal cancer.1–4 Total mesorectal excision is technically demanding and is usually performed as an open transabdominal operation. Since the introduction of laparoscopic resection techniques, the adoption rate
Dis Colon Rectum 2015; 58: 145–153 DOI: 10.1097/DCR.0000000000000265 © The ASCRS 2014 Diseases of the Colon & Rectum Volume 58: 1 (2015)
S
145
146
GÓMEZ RUIZ ET AL: ROBOTIC-ASSISTED LAPAROSCOPIC TRANSANAL TME
Figure 1. Abdominal robotic docking diagram.
of this approach has remained low with high rates of conversion to open laparotomy because of the unique challenges of laparoscopic pelvic dissection.5–7 Recently, several multicenter studies have compared the laparoscopic versus the open approach for rectal cancer treatment finding short-term advantages to laparoscopic surgery but similar oncological results.8,9 Now, some institutions with extensive experience in robotic rectal surgery have published comparative studies between open, laparoscopic, and robotic approaches showing advantages in the robotic group.10 Natural orifice transluminal endoscopic surgery with laparoscopic assistance has been
recently reported in a short series of cases to be feasible with adequate postoperative and anatomopathological results.11–16 Atallah et al17,18 have demonstrated the feasibility of transanal robotic proctectomy. Our group has recently reported on a preclinical cadaveric study19 and a case report20 of robotic-assisted laparoscopic transanal proctectomy with TME, demonstrating that the technique was feasible in a cadaveric model and in a male patient with a BMI of 31 kg/m2. The primary end point of the study was to determine the oncological adequacy of the TME specimen, and secondary end points were to examine short-term perioperative outcomes.
PATIENTS AND METHODS The protocol was approved by the Region of Cantabria (Spain) Research and Ethic Review Board (CEIC Approval code 2013.009). Protocol
Figure 2. Abdominal robotic docking.
Patients attending the outpatient surgery clinic with biopsy-proven adenocarcinoma of the rectum underwent tumor staging with standard protocol (ultrasound, MR of the pelvis, CT, and CEA levels). Eligible patients included men and women 18 years of age and older with clinically staged T2 or T3, N0 or N1, a predicted mesorectal circumferential margin of 5 mm or more on pelvic MRI, and no evidence of metastasis. Patients with T2N1 or T3N0/T3N1 tumors underwent
147
Diseases of the Colon & Rectum Volume 58: 1 (2015)
Figure 3. Partial intersphincteric resection and insufflation of pelvic space steps.
standard preoperative chemoradiation (CRT) with 50.4 Gy and capecitabine for 6 weeks, followed by surgical resection 8 weeks later and the completion of 4 months of postoperative chemotherapy with 5-fluorouracil, leucovorin, and oxaliplatin before ileostomy closure. Additional eligibility criteria included tumors located 3 to 10 cm from the anal verge and 1 cm from the anorectal ring as found by proctoscopy. Patients were excluded if they were older than 70 years, clinically staged T4 or N2, had synchronous colorectal adenocarcinomas, previous colorectal malignancy, extensive previous abdominal or pelvic surgery, or fecal incontinence. Patients not suitable for laparoscopy because of cardiovascular or pulmonary diseases were also excluded. High BMI was not considered an exclusion criterion.
Figure 4. Transanal access port.
A CT scan was performed before discharge in all patients to assess fluid collections in the pelvis after this new approach. Procedure (Video)
With the patient under general anesthesia, a urinary catheter was inserted, and the patient was placed in the lithotomy position with the use of stirrups (see Video, Supplemental Digital Content 1, http://links.lww.com/ DCR/A166). Digital examination and rigid proctoscopy were performed to confirm the tumor location. A Veress needle was inserted in the left upper quadrant and the abdomen was insufflated with CO2 to an average pressure of 12 mmHg. Trocars were inserted in the right upper quadrant (12–15 mm and 8 mm), right lower quadrant (two 8-mm trocars), and periumbilical region (12–15 mm). The patient was positioned in a right tilt, and the peritoneal cavity was first inspected through a standard laparoscope. After confirming the absence of significant intra-abdominal adhesions and no evidence of distal tumor extension, a daVinci Si system (Intuitive Surgical Inc, Sunnyvale, CA) with instruments and accessories was docked from the patient’s left side (Figs. 1 and 2). Monopolar curved scissors were placed in arm 1, a fenestrated bipolar grasper was placed in arm 2, and a double-fenestrated grasper was used in arm 3 (see Fig. 2). A 30° 12-mm endoscope was used. The splenic flexure was taken down with dissection and division of the inferior mesenteric vein and artery at their root. The descending and sigmoid colon were mobilized, finishing the dissection at the sacral promontory. The da Vinci system was undocked, and the patient was repositioned
148
GÓMEZ RUIZ ET AL: ROBOTIC-ASSISTED LAPAROSCOPIC TRANSANAL TME
Figure 5. Transanal robotic docking diagram.
in the Trendelenburg position with a slight right tilt for the next phase of the operation. Partial intersphincteric resection was performed for tumors located at 3 cm from the anal verge. A Lone Star retractor (Lone Star Medical Products Inc, Houston, TX) or a PPH anoscope (Ethicon Endosurgery, Cincinnati, OH) was positioned, and the mucosa and internal sphincter muscle were dissected circumferentially beginning at least 1 cm below the distal margin of the tumor. Intersphincteric dissection was extended
Figure 6. Transanal robotic docking.
cephalad for a distance of 1 to 2 cm, and a pursestring suture was placed to occlude the rectum below the tumor (Fig. 3). Following rectal occlusion, a “Transanal Access Port” proctoscope (PAT, Developia-HUMV, Santander, Spain) (Fig. 4) was inserted transanally, and a GelPoint (Applied Medical Inc, Rancho Santa Margarita, CA) was used to occlude the proctoscope and for trocar placement. A 12-mm or an 8.5-mm trocar was used for the optical port. Two 8-mm trocar ports were inserted with a distance of at least 4 cm for robotic instruments, and an accessory 12-mm trocar was inserted for the assistant port. The da Vinci Patient Cart was then docked over the left hip of the patient (Figs. 5 and 6). The fenestrated bipolar grasper was placed in arm 1 on the left, monopolar scissors were placed in arm 2 on the right, and a 30° endoscope was placed through the 12-mm trocar. The assistant trocar was used primarily to aid in tissue countertraction or to apply suction or irrigation. When partial intersphincteric resection had not previously been done (patients with tumors located higher than 3 cm from anal verge), the rectum was insufflated with CO2 to a pressure of 8 to 10 mmHg. The rectal mucosa was then scored circumferentially with monopolar cautery beginning distal to the pursestring and followed by full-thickness rectal dissection. After rectal wall division, the pelvic space around the remnant anal canal was insufflated to facilitate pelvic dissection and TME (Fig. 3). Anteriorly, the rectum was dissected from the posterior vagina or prostate following Denonvilliers fascia until the peritoneal reflection was reached and divided. Posterior and lateral mesorectal dissection was performed by using a transanal approach with laparoscopic assistance.
149
Diseases of the Colon & Rectum Volume 58: 1 (2015)
Table 1. Patient demographics
Sex
Age, y
BMI, kg/m2
Male Male Female Male Male
55 57 38 67 46
26 31 25 26 22
Patient P01 P02 P03 P04 P05
Comorbidities
Previous abdominal surgeries
ASA
No BPH, Diab, DLP, OSAS No BPH, prostate tumor No
No No No No No
I II II II I
Wexner score 0 1 0 0 0
Soiling No No No No No
Charlson score POSSUM P-POSSUM CR-POSSUM 3.5 5.7 1.7 5.7 2.6
17 17 16 14 12
12 13 12 12 12
12 12 12 8 8
BPH = benign prostatic hypertrophy; Diab = diabetes mellitus; DLP = dyslipidemia; OSAS = obstructive sleep apnea syndrome.
Following adequate colonic mobilization, the rectum was grasped and exteriorized transanally under laparoscopic visualization through a small Alexis Wound Retractor (Applied Medical Inc, Rancho Santa Margarita, CA). A handsewn end-to-end coloanal anastomosis or mechanical end-to-end colorectal anastomosis was performed. A diverting loop ileostomy was created, and a pelvic drain was placed intra-abdominally in all cases. Postoperatively, patients were discharged home when they could tolerate a soft solid diet with a functioning stoma. All vital signs were stable during the hospital stay. All catheters and drains were removed before discharge.
RESULTS From August 2013 to January 2014, 5 patients (4 male and 1 female) underwent robotic-assisted laparoscopic transanal TME. Patient demographics and tumor characteristics are summarized in Tables 1 and 2. Mean patient age and BMI were 57 ± 13.9 years and 25.8 ± 2.7 kg/m2. The mean Charlson Score was 4.25 ± 1.9. The mean POSSUM Score was 16.3 ± 3. Tumors were located in the lower rectum in all patients (
