Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results From the Phase II North American Multicenter Prospective Observational Trial.

OBJECTIVE: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after transanal total mesorectal excision (taTME). BACKGROUND: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter phase II taTME trial demonstrated the safety of taTME in patients with stage I to III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence [Fecal Incontinence Quality of Life (FIQL), Wexner], defecatory function [Colorectal Functional Outcome (COREFO)], urinary function (International Prostate Symptom Score), and sexual function (Female Sexual Function Index-female, International Index of Erectile Function-male) were assessed preoperatively (PQ), 3 to 4 months postileostomy closure (FQ1), and 12 to 18 months post-taTME [postoperative questionnaire 2 (FQ2)]. RESULTS: Among 83 patients who responded at all 3 time points, FIQL, Wexner, and COREFO significantly worsened postileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. International Prostate Symptom Score did not change relative to preoperative scores. For females, Female Sexual Function Index declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, International Index of Erectile Function declined with no change between FQ1 and FQ2. CONCLUSIONS: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.

Transanal total mesorectal excision outcomes for advanced rectal cancer in a complex surgical population.

BACKGROUND: Total mesorectal excision (TME) is the gold standard for oncologic resection in low and mid rectal cancers. However, abdominal approaches to TME can be hampered by poor visibility, inadequate retraction, and distal margin delineation. Transanal TME (taTME) is a promising hybrid technique that was developed to mitigate the difficulties of operating in the low pelvis and to optimize the circumferential resection and distal margins. METHODS: The objective of this study was to characterize our experience implementing taTME at our institution in a technically challenging patient population. We performed a retrospective review of consecutive patients who underwent taTMEs between November 2013 and May 2019 for rectal cancer at a tertiary community cancer center. Outcome measures included pathologic grading of TME specimen, post-operative complications, and oncologic outcomes. RESULTS: Forty-four patients with mid and low rectal cancer underwent low anterior resection via taTME. The most common staging modality was rectal MRI which demonstrated T3 or T4 tumors in 89% of our patients prior to neoadjuvant. Eighty-six percent of patients underwent neoadjuvant chemoradiation. The initial cases were performed sequentially as a single team, but we later transitioned to a synchronous, two-team approach. Ninety-one percent of TME grades were complete or near complete. Only one patient (2.3%) had a positive circumferential margin. Six patients developed anastomotic leaks with an overall anastomotic complication rate of 18.2%. Two patients (4.5%) with primary rectal cancer developed local recurrence, one of which developed multifocal local recurrence. CONCLUSIONS: Using the taTME approach on selected locally advanced low rectal cancers, especially in technically complex irradiated and obese male patients, has yielded comparably safe and effective outcomes to laparoscopic proctectomy.

Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

A natural orifice transrectal approach for oncologic resection of the rectosigmoid: an experimental study and comparison with conventional laparoscopy.

BACKGROUND: A transrectal (TR) approach for natural orifice translumenal endoscopic surgery (NOTES) makes sense for colorectal surgery because the colotomy can be incorporated into subsequent anastomosis. Because cancer is a primary indication for left-sided colon resection, oncologic standards will have to be met by a NOTES procedure. This study aimed to assess whether pure TR rectosigmoidectomy can be performed with strict adherence to oncologic principles compared with a conventional laparoscopically assisted approach (LAP). METHODS: Human male cadavers were allocated to either TR (n = 4) or LAP (n = 2). A simulated sigmoid lesion was created at 25 cm. Transrectal retrograde mobilization of the rectosigmoid was performed using conventional transanal endoscopic microsurgery (TEM) instrumentation. After ligation of the superior hemorrhoidal artery and further mobilization, the specimen was delivered transanally and divided extracorporeally. Using a circular stapler, NOTES colorectal anastomosis was performed. Lymph node yield, adequate resection margins, and operative time were compared with LAP. RESULTS: Transrectal retrograde rectosigmoid dissection was achieved in all attempts (4/4) and showed numbers of lymph nodes (median, 5; range, 3-6) similar to the LAP group (median, 4.5; range, 2-7). One pure TR approach failed to resect the lesion. Three TR procedures required additional mobilization via an abdominal approach to provide adequate margins. The mean length of TR specimens was 16 ± 4 cm compared with 31 ± 9 cm achieved by LAP (p < 0.01). The TR operative time was significantly longer (247 ± 15 vs 110 ± 14 min). CONCLUSION: Lymph node yield during TR rectosigmoidectomy was similar to that achieved by the LAP approach. However, conventional TEM instrumentation alone did not permit adequate colon mobilization. This indicates a need for flexible instrumentation or other technical solutions to perform true NOTES colectomies.

Transanal endoscopic microsurgical platform for natural orifice surgery.

BACKGROUND: The excitement surrounding natural orifice transluminal endoscopic surgery (NOTES) remains tempered by concerns over safe access and closure of transvisceral enterotomies. Research in NOTES has commonly been described as using an oral transgastric access point. Transanal endoscopic microsurgery (TEM) is a minimally invasive technique for a full-thickness resection of rectal tumors and with suture closure of the resultant defect with highly specialized instruments. This technique has been used clinically in human beings for more than 2 decades. Entry into the peritoneal cavity during a resection of rectosigmoid lesions has been described, and safe closure can be obtained. OBJECTIVE: To assess the feasibility of transrectal NOTES procedures by using TEM instrumentation. DESIGN: Three porcine and 3 human cadaver models were studied by using standard TEM instrumentation and flexible endoscopes. NOTES peritoneal access, a peritoneoscopy, a liver biopsy, and colorectal resections were performed. RESULTS: True NOTES procedures facilitated with TEM instrumentation were successfully completed. LIMITATIONS: This was a preclinical study, and several challenges to bridging to human clinical use exist: TEM instruments are currently designed for intraluminal tasks low in the pelvis, with 5-mm to 10-mm port sizes; the cost of the TEM instruments and insufflation system; and the learning curve to perform TEM closure. CONCLUSIONS: Our preclinical study demonstrated the feasibility of several transrectal NOTES procedures, colorectal resection, and anastomosis when using TEM instrumentation. We, therefore, suggest TEM as a portal for NOTES.

Transanal endoscopic microsurgery (TEM) resection of rectal tumors.

Local excision of rectal cancer is an attractive alternative to avoid the morbidity associated with radical rectal surgery. Oncologic concerns, specifically the inability to fully assess the status of the perirectal lymph nodes and the risk of local recurrence after local excision remain significant barriers to widespread adoption of this technique. Transanal endoscopic microsurgery is an alternative minimally invasive technique used for transanal excision of rectal polyps and tumors. It offers the advantage of better exposure, magnified stereoscopic view, and greater reach into the middle and upper rectum. This technique, combined with careful patient selection, has demonstrated optimistic results compared to standard transanal techniques and even total mesorectal excision when utilized for certain early rectal cancers.

Full-thickness intraperitoneal excision by transanal endoscopic microsurgery does not increase short-term complications.

PURPOSE: Transanal endoscopic microsurgery (TEM) is a minimally invasive technique for full-thickness excision of benign and malignant rectal neoplasms located 4 to 24 cm above the anal verge. Entrance into the peritoneal cavity during TEM has been regarded as a complication that mandates conversion to open laparotomy for adequate repair of the defect. This study compares the rate of complications arising from TEM with and without intraperitoneal entry. METHODS: Patients undergoing peritoneal entry were compared to those who did not. RESULTS: No perioperative deaths occurred. There was no significant difference in the incidence of postoperative complications. No major complications occurred with peritoneal entry, and all peritoneal entries were closed transanally via endoscope. CONCLUSIONS: Entry into the peritoneum during TEM is not associated with an increased incidence of complication. Entry into the peritoneum during TEM excision does not mandate conversion to open laparotomy but may be safely repaired endoscopically. Lesions likely to be above the peritoneal reflection and within reach of the endoscope (4 to 24 cm) should be considered for TEM excision.

The rational use of computed tomography scans in the diagnosis of appendicitis.

BACKGROUND: Recently, limited abdominal computed tomography (CT) scans have been reported (Rao, New England Journal of Medicine, 1998) to have accuracy as high as 98%. We compare our hospital's CT accuracy ordered by emergency room (ER) physicians with that of experienced surgeons provided only with the ER history and physical examination in the evaluation of appendicitis. METHODS: All charts of patients 16 years or older with limited CT scans ordered by ER from January 1, 1996, through February 28, 1998, were reviewed. CT scans ordered when appendicitis was not in the differential were excluded from analysis. Pathology and clinical follow-up were criterion standards. Four surgeons reviewed ER history and physical and placed them into one of three categories: appendectomy, observe to rule out appendicitis, or discharge with follow-up (included admitting to another service or treating for another disorder). RESULTS: A total of 526 charts were reviewed; 129 met the criteria for the study. The accuracy of CT scans as used by our ER was not as high as reported in the literature. In addition, surgeon accuracy approached that of the CT scan even without the ability to evaluate the patients in person. Noncontrast CTs were ordered before surgical evaluation in contrast to the Rao protocol, likely reducing their accuracy. CONCLUSIONS: Ordering CT scans to evaluate for appendicitis prior to surgical evaluation is of limited value.

Prospective study of colorectal enhanced recovery after surgery in a community hospital.

IMPORTANCE: Enhanced recovery after surgery (ERAS) colorectal programs have shown to be successful at reducing length of stay in many international and academic centers; however, their efficacy in a community hospital setting remains unclear. OBJECTIVE: To determine if favorable results could be reproduced in a community hospital setting using our ERAS program, which was developed using core ERAS guidelines with the goal of accelerated recovery while also addressing other important outcomes affecting patient experience and safety. DESIGN, SETTING, AND PARTICIPANTS: Prospective study of ERAS program, a multidisciplinary effort involving anesthesia, preadmission staff, nursing, and surgery staff at a community hospital. The program was initiated in 2010 and was in full practice by 2011. We assessed practice patterns and patient outcomes for all elective colon and rectal resection cases performed in 2009 (prior to ERAS implementation), 2011, and 2012. MAIN OUTCOMES AND MEASURES: Laparoscopic approach, narcotic use, length of stay, 30-day readmission, ileus (defined as reinsertion of nasogastric tube), and intra-abdominal infection and association between colorectal cancer (CRC) diagnosis and these outcomes. RESULTS: From 2009 to 2012, the use of laparoscopy increased from 57.4% to 88.8% (P < .001). Length of stay decreased significantly (6.7 days vs 3.7 days, P < .001), without an increase in 30-day readmission rate (17.6% vs 12.5%, P = .49). Use of patient-controlled narcotic analgesia and duration of use decreased (63.2% of patients vs 15%, P < .001; 67.8 hours vs 47.1 hours, P = .02). Ileus rate decreased from 13.2% to 2.5% (P = .02). Intra-abdominal infection decreased from 7.4% to 2.5% (P = .24). When comparing laparoscopic cases alone, similar results were observed. Following regression analysis, there were no statistically significant differences between CRC diagnosis and LOS, 30-day readmission rates, ileus, and intra-abdominal infection (all P's > .05). Length of stay reductions resulted in an estimated cost savings of $3202 per patient (2011) and $4803 per patient (2012). CONCLUSIONS AND RELEVANCE: Implementation of this patient care-directed enhanced recovery program is feasible in a community hospital setting, and it is associated with decreased LOS without increased readmission or morbidity, as well as significant decreases in narcotic use and cost. Improved outcomes are independent of the laparoscopic approach and CRC diagnosis.

Perianal abscess/fistula disease.

Perirectal abscesses and fistulas represent the acute and chronic manifestations of the same disease process, an infected anal gland. They have beleaguered patients and physicians for millennia. A thorough understanding of the anatomy and pathophysiology of the disease process is critical for optimal diagnosis and management. Abscess management is fairly straightforward, with incision and drainage being the hallmark of therapy. Fistula management is much more complicated. It requires striking a balance between rates of healing and potential alteration of fecal continence. This, therefore, requires much more finesse. Many techniques are now available in the armamentarium of the surgeon who treats fistula-in-ano. Although no single technique is appropriate for all patients and all fistula types, appropriate selection of patients and choice of repair technique should yield higher success rates with lower associated morbidity.

Emerging technologies including robotics and natural orifice transluminal endoscopic surgery (NOTES) colorectal surgery.

Endoluminal and minimally invasive techniques have a long history and bright future in colorectal surgery. First, we will examine how old (colonoscopy) and new (laparoscopy) techniques combine in the form of laparoscopically assisted colonoscopic polypectomy for removal of "colonoscopically unresectable" colon polyps. Next, we will review the early experiences with robot-assisted minimally invasive colon resections. Lastly, we will introduce the next frontier in minimally invasive surgery, natural orifice transluminal endoscopic surgery (NOTES).

Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised).

The American Society of Colon and Rectal Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Standards Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This Committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive, and not prescriptive. Their purpose is to provide information on which decisions can be made, rather than dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

Practice parameters for the surgical treatment of ulcerative colitis.

The American Society of Colon and Rectal Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Standards Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive, and not prescriptive. Their purpose is to provide information on which decisions can be made, rather than dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

Effects of estrogen on messenger ribonucleic acid expression patterns of extracellular matrix proteases in the primate colon.

PURPOSE: Recent studies suggest that hormone replacement therapy in postmenopausal women can decrease colon cancer risk. To better understand the molecular effects of estrogen on the colon, we examined the effects of estrogen replacement on gene expression of proteases associated with extracellular matrix degradation in rhesus monkey colon tissue. METHODS: Rhesus monkeys were oophorectomized and one-half were implanted with estradiol capsules. After five months, colon tissue was harvested, and messenger ribonucleic acid was extracted and converted to cDNA. The cDNA was hybridized with a DNA array spotted with cDNA corresponding to genes involved in extracellular matrix remodeling. Selected genes exhibiting significant differential expression were validated using reverse transcriptase-polymerase chain reaction and real-time polymerase chain reaction analysis. RESULTS: Of 96 genes assessed, nearly 18 percent showed a twofold or greater change in expression; however, signals from approximately 65 percent of genes assayed were below detection levels. A distinct pattern of decreased gene expression was observed in colon tissue of animals with estrogen implants compared with females without estrogen replacement. Reverse transcriptase-polymerase chain reaction confirmed decreased expression in estrogen-replaced vs. hormone-deprived tissues of proteases cathepsin-D and caspase-8. Real-time polymerase chain reaction data confirmed the suppression of proteases A disintegrin and mettaloproteinase with thrombospondin motifs, type 1 and matrix metalloproteinase-2 with estrogen replacement in colon tissue. CONCLUSIONS: This is the first investigation of the specific effects of estrogen in normal primate colon. Estrogen replacement suppressed expression of several proteases linked to tumor growth and metastasis. This study provides the groundwork for targeted future studies to further characterize the role of estrogen in colon tissue.