Sergio W. Larach

Early results of laparoscopic surgery for colorectal cancer - Retrospective analysis of 372 patients treated by clinical outcomes of Surgical Therapy (Cost) Study Group

PURPOSE: This study was undertaken to determine the early experience of the embers of the COST Study Group with colorectal cancer treated by laparoscopic approaches. METHOD: A retrospective review was performed of all patients with colorectal cancer treated with laparoscopy by the COST Study Group before August 1994. Tumor site, stage, differentiation, procedure completion, presence of recurrence (local, distant, trocar site), and cause of death were analyzed. RESULTS: A total of 372 patients with adenocarcinoma of the colon and rectum were treated by laparoscopic approach between October 1991 and August 1994 (170 men and 192 women): right colectomy, 170; sigmoid colectomy, 55; low anterior resection, 56; abdominoperineal resection, 44; left colectomy, 22; colostomy, 8; total colectomy, 6; transverse colectomy, 7; exploration, 2. Conversion to an open procedure was required in 15.6 percent of cases. Operative mortality was 2 percent. Tumor characteristics were as follows: TNM state: I, 40 percent; II, 25 percent; III, 18 percent; IV, 17 percent; Differentiation: well-moderate, 88 percent; poor, 12 percent; carcinomatosis, 5 percent. Local (3.6 percent) and distant implantation occurred in four patients (1.1 percent). Only one of these patients died a cancer-related death (Stage III at 36 months). Cancer-related death rates increased with increasing stage of tumor: I, −4 percent; II, 17 percent; III, 31 percent; IV, 70 percent. CONCLUSION: A laparoscopic approach to colorectal cancer results in early outcome after treatment that is comparable with conventional therapy for colorectal cancer. A randomized trial is needed to compare long-term outcomes of open and laparoscopic approaches with colorectal cancer.

Laparoscopic resections for colorectal carcinoma : a three-year experience

Laparoscopic resection for carcinoma of the colon and rectum is currently under intense scrutiny. PURPOSE: The purpose of this study is to review our three-year experience of laparoscopic surgery for colon and rectal carcinoma. METHODS: From October 1991 to September 1994, 76 laparoscopic procedures were performed for colorectal neoplasia (32 males and 44 females; mean age, 69 years). Fifty-five procedures were done for carcinoma, 16 for large polyps, and five for diversion in patients with unresectable cancer. For resectable tumors, the average size was 4 cm; staging was as follows: Dukes A, 10 patients; Dukes B1, 11; Dukes B2, 18; Dukes C1, 1; Dukes C2, 9; and Dukes D, 8. Fourteen cases (25 percent) that were converted to open procedures were compared with the 41 cases that were completed laparoscopically for differences in tumor size, surgical margins, number of lymph nodes harvested, length of hospital stay, and evidence of recurrence. Procedures completed laparoscopically were then compared with a group of open controls completed during the same time period. RESULTS: During the first six months, the conversion rate was 32 percent but dropped to 8 percent in the last six months. There were a total of 19 complications (25 percent), of which 8 (14 percent) were directly related to the laparoscopic technique. The mean number of lymph nodes harvested in laparoscopic resection for carcinoma was 8.5, and the average closest tumor margin was 4.5 cm. When laparoscopic resections were compared with converted and standard open colectomies, there was no significant difference in tumor margins or numbers of nodes resected. Length of stay was significantly shorter for anterior resections completed laparoscopically than for converted or conventional colectomies. Although this was also the trend for right hemicolectomies, it did not reach statistical significance. Mean follow-up of the group completed laparoscopically was 16.7 months, during which there was one recurrence. There were no trocar site recurrences. CONCLUSIONS: This early experience seems to indicate that laparoscopic surgery for colorectal carcinoma does not per se compromise surgical oncologic principles and encourages us to continue our critical appraisal of this technique.

Transanal minimally invasive surgery (TAMIS) for local excision of benign neoplasms and early-stage rectal cancer: efficacy and outcomes in the first 50 patients.

BACKGROUND: Since its inception in 2009, transanal minimally invasive surgery has been used increasingly in the United States and internationally as an alternative to local excision and transanal endoscopic microsurgery for local excision of neoplasms in the distal and mid rectum. Despite its increasing acceptance, the clinical benefits of transanal minimally invasive surgery have not yet been validated. OBJECTIVE: The aim of this study is to assess the adequacy of transanal minimally invasive surgery for the local excision of benign and malignant lesions of the rectum. DESIGN: This is a retrospective analysis of consecutive patients who underwent transanal minimally invasive surgery for local excision of neoplasms at a single institution. SETTINGS: The study was conducted by a single group of colorectal surgeons at a tertiary referral center. PATIENTS: Eligible patients with early-stage rectal cancer and benign neoplasms were offered transanal minimally invasive surgery as a means for local excision. Data from these patients were collected prospectively in a registry. MAIN OUTCOME MEASURES: The primary outcome measures included the feasibility of transanal minimally invasive surgery for local excision, resection quality, and short-term clinical results. RESULTS: Fifty patients underwent transanal minimally invasive surgery between July 2009 and December 2011. Twenty-five benign neoplasms, 23 malignant lesions, and 2 neuroendocrine tumors were excised. All lesions were excised using transanal minimally invasive surgery without conversion to an alternate transanal platform. The average length of stay was 0.6 days (range, 0–6), and 68% of patients were discharged on the day of surgery. The average distance from the anal verge was 8.1 cm (range, 3–14 cm). All lesions were excised completely with only 2 fragmented specimens (4%). All specimens were removed with grossly negative margins, although 3 (6%) were found to have microscopically positive margins on final pathology. There were 2 recurrences (4%) at 6- and 18-month follow-up. Early complications occurred in 3 patients (6%). No long-term complications were observed at a median follow-up of 20 months. LIMITATIONS: The study was limited by its retrospective nature and midterm follow-up. CONCLUSIONS: Transanal minimally invasive surgery is an advanced transanal platform that provides a safe and effective method for resecting benign neoplasms, as well as carefully selected, early-stage malignancies of the mid and distal rectum.

Prospective comparison of laparoscopic vs. open resections for colorectal adenocarcinoma over a ten-year period

AbstractPURPOSE: The aim of this study was to define the long-term oncologic outcomes of laparoscopic resections for colorectal cancer. METHODS: We analyzed our experience via a prospective, nonrandomized, longitudinal cohort study. The period of study extended from April 1991 to May 2001. Laparoscopic resection was offered selectively in the absence of a large mass, invasion into abdominal wall or adjacent organs, and multiple prior abdominal operations. Every laparoscopic resection performed with curative intent for adenocarcinoma was included. Twenty percent of patients whose procedures were converted to open resection were included in the laparoscopic-resection group because of intention to treat. Oncologic outcome measures of this group were compared with a computerized, case-matched, open-resection group, the case-matching variables being age, gender, site of primary tumor (colon vs. rectum), and TNM stage. The laparoscopic-resection group was followed up prospectively, and data were updated regularly. The follow-up techniques consisted of a combination of office visits, telephone calls, and the United States Social Security Death Index database. RESULTS: The laparoscopic-resection group consisted of 172 patients with a mean age of 67 (range, 27–85) years. The open-resection group consisted of 172 patients with a mean age of 69 (range, 30–90) years. Mean follow-up was 52 (range, 3–128) months. Complete (100 percent) follow-up data were available. The TNM stage distribution was 63 Stage I (37 percent), 51 Stage II (30 percent), 47 Stage III (27 percent), and 11 Stage IV (6 percent) tumors for the laparoscopic-resection group and 65 Stage I (38 percent), 48 Stage II (28 percent), 51 Stage III (29 percent), and 8 Stage IV (5 percent) tumors for patients in the open-resection group (P = 0.75, not significant). Thirty-day mortality was 1.2 percent (2 deaths) in the laparoscopic-resection group and 2.4 percent (4 deaths) in the open-resection group (P > 0.05, not significant). Early and late complication incidences were comparable. Local recurrence was observed in three patients (1.7 percent) in the laparoscopic resection group with the primary tumor in the colon and in three patients (1.7 percent) with the primary tumor in the rectum, for a total incidence of local recurrence in the laparoscopy group of 3.5 percent (6 patients). In the open-resection group, local recurrence was observed in two patients (1.2 percent) among those with primary tumor site in the colon and in three patients (1.7 percent) in the group with primary tumor in the rectum, for a total incidence of local recurrence in the open-resection group of 2.9 percent (5 patients). One of the local recurrences in the laparoscopy group occurred in the port/extraction site, for an incidence of 0.6 percent. Metastasis occurred in 18 patients (10.5 percent) in the open group and in 21 (12.2 percent) in the laparoscopy group. Stage-for-stage overall five-year survival rates were similar in the two groups. The Kaplan-Meier statistical analysis performed for colonic vs. rectal primary adenocarcinoma confirmed that TNM stage for stage-overall survival was similar in the laparoscopic and open-resection groups (log-rank P = 0.22). CONCLUSIONS: Notwithstanding the drawbacks of a nonrandomized study, no adverse long-term oncologic outcomes of laparoscopic resections for colorectal cancer were observed in a single center’s experience during a ten-year period.

Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: A prospective, randomized, evaluator-blinded multicenter study

INTRODUCTIONPostoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients.METHODSTwelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no antiadhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision.RESULTSData were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose.CONCLUSIONSGlycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.

A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures

AbstractPURPOSE: The aim of this study was to determine the optimal dose and dosing interval of nitroglycerin ointment to heal chronic anal fissures. METHOD: A randomized, double-blind study of intra-anally applied nitroglycerin ointment (Anogesic™) was conducted in 17 centers in 304 patients with chronic anal fissures. The patients were randomly assigned to one of eight treatment regimens (0.0, 0.1, 0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight weeks. A dose-measuring device standardized the delivery of 374 mg ointment. Healing of fissures (complete reepithelialization) was assessed by physical examination using an observer unaware of treatment allocation. The subjects assessed pain intensity daily by completing a diary containing a visual analog scale for average pain intensity for the day, the worst pain intensity for the day, and pain intensity at the last defecation. RESULTS: There were no significant differences in fissure healing among any of the treatment groups; all groups, including placebo had a healing rate of approximately 50 percent. This rate of placebo response was inexplicably higher than previously reported in the literature. Treatment with 0.4 percent (1.5 mg) nitroglycerin ointment was associated with a significant (P < 0.0002) decrease in average pain intensity compared with vehicle as assessed by patients with a visual analog scale. The decreases were observed by Day 4 of treatment. At 8 weeks the magnitude of the difference between 0.4 percent nitroglycerin and control was a 21 percent reduction in average pain. Treatment was well tolerated, with only 3.29 percent of patients discontinuing treatment because of headache. Headaches were the primary adverse event and were dose related. CONCLUSION: Nitroglycerin ointment did not alter healing but significantly and rapidly reduced the pain associated with chronic anal fissures.

Postoperative surveillance recommendations for early stage colon cancer based on results from the clinical outcomes of surgical therapy trial

4013 Background: Intensive postoperative surveillance is associated with improved survival and recommended for patients with late stage (stage IIB & III) colon cancer. We hypothesized that stage I & IIA colon cancer patients would experience similar benefits. METHODS Secondary analysis of data from the Clinical Outcomes of Surgical Therapy trial was performed by analyzing results according to TNM stage; early (stage I & IIA; 537 patients) and late (stage IIB & III; 254 patients) stage disease. Five-year recurrence rates were higher in patients with late (35.7%) versus early stage disease (9.5%). Early and late stage salvage rates, recurrence patterns and methods of first detection were compared by χ2 test. RESULTS Salvage rates for early and late stage disease patients with recurrence were the same (35.9% versus 37%, p=0.9 respectively). Median survival following second surgery after recurrence was 35.8 months late stage and 51.2 months for early stage patients respectively. Sites of first recurrence did not significantly differ between late and early stage disease: liver (37.4% vs. 27.2%); lung (29.7% vs.23.6%); intraabdominal (24.2% vs.10.9%); and locoregional (12.1% vs.10.9%). Methods of first detection of recurrence were also not significantly different: CEA (37.4% vs. 29.1%); CT scan (26.4% vs. 23.6%); chest X-ray (12.1% vs. 7.3%); and colonoscopy (8.8% vs. 12.7%), for late versus early stage disease, respectively. CONCLUSIONS Patients with early stage colon cancer have similar sites of recurrence, and receive similar benefit from post-recurrence therapy as later stage patients; implementation of existing surveillance guidelines for early stage patients is appropriate. No significant financial relationships to disclose.PURPOSE Intensive postoperative surveillance is associated with improved survival and recommended for patients with late stage (stage IIB and III) colon cancer. We hypothesized that stage I and IIA colon cancer patients would experience similar benefits. PATIENTS AND METHODS Secondary analysis of data from the Clinical Outcomes of Surgical Therapy trial was performed by analyzing results according to TNM stage; early (stage I and IIA, 537 patients) and late (stage IIB and III, 254 patients) stage disease. Five-year recurrence rates were higher in patients with late (35.7%) versus early stage disease (9.5%). Early and late stage salvage rates, recurrence patterns and methods of first detection were compared by chi(2) test. RESULTS Salvage rates for early- and late-stage disease patients with recurrence were the same (35.9% v 37%; P = .9, respectively). Median survival after second surgery after recurrence was 51.2 and 35.8 months for early- and late-stage patients, respectively. Single sites of first recurrence did not significantly differ between early and late stage, but multiple sites of recurrence occurred less often in early-stage patients (3.6% v 28.6%, for early v late, respectively; P < .001). METHODS of first detection of recurrence were not significantly different: carcinoembryonic antigen (29.1% v 37.4%), computed tomography scan (23.6% v 26.4%), chest x-ray (7.3% v 12.1%), and colonoscopy (12.7% v 8.8%), for early versus late stage disease, respectively. CONCLUSION Patients with early-stage colon cancer have similar sites of recurrence, and receive similar benefit from postrecurrence therapy as late-stage patients; implementation of surveillance guidelines for early-stage patients is appropriate.

Surgeon volume does not predict outcomes in the setting of technical credentialing: Results from a randomized trial in colon cancer

Objective:To test the hypothesis that surgeon volume would not predict short- and long-term outcomes when evaluated in the setting of technical credentialing. Summary Background Data:Surgical volume is a known predictor of outcomes; the importance of technical credentialing has not been evaluated. Methods:Fifty-three credentialed surgeons operated on 871 patients in the Clinical Outcomes of Surgical Therapy Study (NCT00002575), investigating laparoscopic versus open surgery for colon cancer. Credentialing required that each surgeon document performance of at least 20 laparoscopic colon cases and demonstrate oncologic techniques on a video-recorded case. Surgeons were separated based on volume entered into the trial (low, ≤5 cases (n = 39); medium, 6–10 cases (n = 9); or high, >10 cases (n = 5)) and compared by outcomes. Results:Patients treated by high volume compared with medium or low volume surgeons were older (70, 66, and 68 years; P < 0.001), more often had right-sided tumors (63%, 46%, and 53%; P < 0.001) and had more previous operations (48%, 38% and 45%; P < 0.004), respectively. Mean operative times were shorter (123, 147 and 145 minutes; P < 0.001), distal margins longer (13.4, 12.4 and 11.6 cm; P = 0.005), and lymph node harvest greater (14.8, 12.8, 12.6; P = 0.05) for high versus medium versus low volume surgeons. However, rates of conversion, complications, 5-year survival, and disease-free survival showed no significant differences. Conclusion:When tested in a randomized controlled trial with case-specific surgical technical credentialing and auditing, surgeon volume did not predict differences in rates of conversion, complications, or long-term cancer outcomes. Case-specific technical credentialing should be further studied specific to the role it could play in creating consistent, high quality outcomes.

Biofeedback in colorectal practice: A multicenter, statewide, three-year experience

PURPOSE: Biofeedback treatment is often offered to patients in colorectal centers; however, standards of treatment are still lacking. A dedicated team approach is desirable but difficult to coordinate. We present our three-year experience of electromyographic-based biofeedback treatment offered within a multicenter, statewide organization. METHODS: Between October 1992 and October 1995, 188 patients completed a biofeedback treatment program in one of five coordinated centers within a 200-mile radius. A unified common database was established and continuously updated. A colorectal surgeon served as statewide director, and dedicated teams were established at each location. Each local team included the medical director and a certified biofeedback therapist and had access to a dietitian and a nurse data coordinator. Electromyographic-based biofeedback sessions were given weekly, and a home trainer program was established. RESULTS: A total of 116 patients with chronic constipation had a mean of eight (range, 2–14) weekly sessions. A total of 72 patients with fecal incontinence had a mean of seven (range, 2–11) weekly sessions. A total of 84 percent of the constipated and 85 percent of the incontinent patients had significant improvement with biofeedback treatment. Patient compliance and satisfaction were high. Constipated patients increased the mean number of weekly unassisted bowel movements from 0.8 to 6.5. Incontinent patients decreased the mean number of weekly gross incontinence episodes from 11.8 to 2. CONCLUSIONS: Biofeedback treatment can be extremely successful in both incontinent and constipated patients. A large geographic area can be covered with coordinated centers in which each dedicated team uses a unified treatment protocol, and a common database is established.

Intraoperative use of toradol® facilitates outpatient hemorrhoidectomy

Pain after hemorrhoidectomy is widely feared by many patients who are mostly still treated with oral/intramuscular narcotics to control their pain postoperatively. PURPOSE: In an effort to decrease posthemorrhoidectomy pain by applying newer methods of analgesia, a prospective trial was conducted to investigate the postoperative analgesic effect of Toradol® (ketorolac tromethamine; Syntex Labs, Palo Alto, CA) injected into the sphincter muscle at the time of hemorrhoidectomy and taken orally during a five-day postoperative period in a group of 24 patients (Toradol® group). Results were compared with two other groups of matching patients: one group (narcotics, n=18) treated with standard postoperative narcotic intramuscular/oral analgesics after overnight hospital stay, and a group (SQMP, n=21) previously treated by one of us with outpatient, subcutaneous infusion of morphine sulfate (Roxane Laboratories, Columbus, OH) via a home infusion pump. METHOD: The length of hospitalization, severity of postoperative pain and complications, costs, and side effects were analyzed by patient questionnaire at the time of the first postoperative visit and hospital and clinic records were reviewed. Differences between groups were analyzed using Students t-test withP<0.05 being significant. RESULTS: Subjective pain response and hospitalization cost were significantly less in the SQMP group; however, this was at the expense of increased postoperative complications (urinary retention) and side effects (day until first bowel movement, nausea) although without a decrease in satisfaction rating. The Toradol® group had pain control equivalent to that of the narcotics group, a higher satisfaction rating, and suffered no increase in complications relative to either group. Significantly, there was no urinary retention in the Toradol® group. CONCLUSION: Postoperative pain after hemorrhoidectomy can be safely controlled as an outpatient using newer methods of pain control. These include both constant-infusion pain pump or supplemental use of the nonsteroidal analgesic ketorolac, both of which allow early release of the patient the day of surgery by diminishing postoperative pain. An important advantage of local injection of ketorolac is the elimination of urinary retention in our study group, probably by blunting the pain reflex response facilitated by prostaglandins, thus allowing safe same-day discharge.