Peter W. Marcello

Prospective, randomized trial comparing laparoscopic vs. conventional surgery for refractory ileocolic Crohn's disease.

INTRODUCTION: Surgeons have been reluctant to apply laparoscopic techniques to Crohns disease surgery because of concerns with evaluating and excising inflamed tissue using laparoscopic methods Additionally in Crohns disease surgery, laparoscopic techniques have not been demonstrated to have clear advantages over conventional ones. METHOD: We conducted a prospective, randomized trial in one surgical department comparing laparoscopic vs. conventional techniques in 60 patients (25 males), median age 34.4 (range 10–60.1) years, undergoing elective ileocolic resection for refractory Crohns disease. Postoperatively, all patients underwent measurement of pulomnary function tests every 12 hours, and were treated identically on a highly controlled protocol with regard to analgesic administration, feeding, and postoperative care. RESULTS: Of the 31 patients assigned to laparoscopic and 29 to the conventional group, all had isolated Crohns disease of the terminal ileum plus or minus the cecum. Median length of the incision was 5 cm in the laparoscopic group and 12 cm in the conventional group. Overall recovery of 80 percent of forced expiratory volume (one second) and forcec vital capacity was a median of 2.5 days for laparoscopic and 3.5 days for conventional (P=0.03). There was no difference in the amount of morphine equivalents used between groups postoperatively. Flatus and first bowel movement returned a median of 3 and 4 days, respectively, after conventional roscopicvs. 3.3 and 4 days, respectively, after conventional surgery (P=0.21). Median length of stay was five (range, 4–30) days for laparoscopic, and six (range, 4–18) days for conventional surgery. Major complications occurred in one patient in each group. Minor complications occurred in four laparoscopic and eight conventional patients (P<0.05). There were no deaths. Two laparoscopic patients were converted to conventional as a result of adhesions or inflammation. All patients recovered well and there were no clinical resurrences in the follow-up period (median, 20; range, 12–45 months). CONCLUSIONS: Within a single insititution, single surgical team, prospective, randomized trial, laparoscopic techniques offered a faster recovery of pulomary function, fewer complications, and shorter length of stay compared with conventional surgery for selected patients undergoing ileocolic resection for Crohns disease.

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial

IMPORTANCE Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00726622.

Laparoscopic restorative proctocolectomy: case-matched comparative study with open restorative proctocolectomy.

PURPOSE: A laparoscopic approach to restorative proctocolectomy is new and has not been compared recently with the traditional open procedure. By using prospectively gathered data, laparoscopic and open restorative proctocolectomy procedures in mucosal ulcerative colitis and familial adenomatous polyposis patients were compared by using a case-matched design. METHODS: Forty patients, composing 20 consecutive laparoscopic cases (13 mucosal ulcerative colitis, 7 familial adenomatous polyposis), were matched for age, gender, and body mass index with 20 open cases (13 mucosal ulcerative colitis, 7 familial adenomatous polyposis) performed during the same time period. Mucosal ulcerative colitis patients were also matched for severity of disease by using hemoglobin and albumin levels, whole blood count, and steroid dependency. A loop ileostomy was made in 12 of 13 laparoscopic mucosal ulcerative colitis patients, all open mucosal ulcerative colitis patients, and no familial adenomatous polyposis patients. RESULTS: The median age was 25 (range, 9–61) years. There were no intraoperative complications in either group and no conversions in the laparoscopic group. The operative times (median, range) were significantly longer in laparoscopic cases (330, 180–480 minutes)vs. open cases (230, 180–300 minutes),P<0.001. Bowel function returned more quickly in laparoscopic cases (2, 1–8 days)vs. open cases (4, 1–13 days),P=0.03; and the length of stay was shorter in laparoscopic cases (7, 4–14 days)vs. open cases (8, 6–17 days),P=0.02. For diverted patients, the median length of stay was reduced by two days in laparoscopic cases (6, 4–14 days)vs. open cases (8, 6–17 days),P=0.01. Complications occurred in 4 of 20 laparoscopic patients (3 obstruction/ileus and 1 pelvic abscess) and 5 of 20 open patients (2 obstruction and ileus, 1 each anastomotic leak and abscess, peptic ulceration, and episode of dehydration). CONCLUSIONS: Return of intestinal function and length of stay are reduced in the laparoscopic group compared with open group. A laparoscopic approach to restorative proctocolectomy has the potential of becoming an appealing alternative to conventional restorative proctocolectomy surgery.

Hand-Assisted Laparoscopic vs. Laparoscopic Colorectal Surgery: A Multicenter, Prospective, Randomized Trial

PurposeThis study was designed to compare short-term outcomes after hand-assisted laparoscopic vs. straight laparoscopic colorectal surgery.MethodsEleven surgeons at five centers participated in a prospective, randomized trial of patients undergoing elective laparoscopic sigmoid/left colectomy and total colectomy. The study was powered to detect a 30-minute reduction in operative time between hand-assisted laparoscopic and straight laparoscopic groups.ResultsThere were 47 hand-assisted patients (33 sigmoid/left colectomy, 14 total colectomy) and 48 straight laparoscopic patients (33 sigmoid/left colectomy, 15 total colectomy). There were no differences in the patient age, sex, body mass index, previous surgery, diagnosis, and procedures performed between the hand-assisted and straight laparoscopic groups. Resident participation in the procedures was similar for all groups. The mean operative time (in minutes) was significantly less in the hand-assisted laparoscopic group for both the sigmoid colectomy (175 ± 58 vs. 208 ± 55; P = 0.021) and total colectomy groups (time to colectomy completion, 127 ± 31 vs. 184 ± 72; P = 0.015). There were no apparent differences in the time to return of bowel function, tolerance of diet, length of stay, postoperative pain scores, or narcotic usage between the hand-assisted laparoscopic and straight laparoscopic groups. There was one (2 percent) conversion in the hand-assisted laparoscopic group and six (12.5 percent) in the straight laparoscopic group (P = 0.11). Complications were similar in both groups (hand-assisted, 21 percent vs. straight laparoscopic, 19 percent; P = 0.68).ConclusionsIn this prospective, randomized study, hand-assisted laparoscopic colorectal surgery resulted in significantly shorter operative times while maintaining similar clinical outcomes as straight laparoscopic techniques for patients undergoing left-sided colectomy and total abdominal colectomy.

Randomized phase I/II trial of a macrophage-specific immunomodulator (PGG-glucan) in high-risk surgical patients

ObjectiveThe safety and efficacy of PGG-glucan in surgical patients at high risk for postoperative infection who underwent major thoracic or abdominal surgery were determined. Summary Background DataRecent studies have reported a 25% to 27% infectious complication rate in patients undergoing major surgery with an average cost per infected patient of

Long-Term Follow-up After an Initial Episode of Diverticulitis: What Are the Predictors of Recurrence?

12,000. The efficacy of PGG-glucan pretreatment in prevention of sepsis has been demonstrated in rodent models for gram-negative and gram-positive bacterial and yeast infections. In vitro studies have demonstrated enhanced microbial killing by monocytes and neutrophils in healthy volunteers after PGG-glucan administration. Thus, PGG-glucan may play a role in decreasing the infectious complication rate in patients undergoing major surgery. MethodsA double-blind, placebo-controlled randomized study was performed in 34 high-risk patients undergoing major abdominal or thoracic surgery. ResultsThere were no adverse drug experiences associated with PGG-glucan infusion. Patients who received PGG-glucan had significantly fewer infectious complications (3.4 infections per infected patient vs. 1.4 infections per infected patient, p = 0.05), decreased intravenous antibiotic requirement (10.3 days vs. 0.4 days, p = 0.04) and shorter intensive care unit length of stay (3.3 days vs. 0.1 days, p = 0.03). ConclusionsPGG-glucan is safe and appears to be effective in the further reduction of the morbidity and cost of major surgery.

The Fate of the Ileal Pouch in Patients Developing Crohn’s Disease

PURPOSE: The purpose of our study was to determine the clinical and CT predictors of recurrent disease after a first episode of diverticulitis that was successfully managed nonoperatively. METHODS: We retrospectively analyzed 954 consecutive patients who presented to our institution with diverticulitis from 2002 to 2008. Patients were identified with International Classification of Diseases, 9th Revision/Current Procedural Terminology codes. Patients were excluded if they had subsequent colectomy based on the first attack (n = 81), or if the attack they had between 2002 and 2008 was not their first attack (n = 201). We evaluated CT variables chosen by a panel of expert gastrointestinal radiologists. These radiologists reviewed the available published literature for CT imaging characteristics thought to predict diverticulitis severity. CT variables (n = 20) were determined by prospective reevaluation of scans by blinded study radiologists. Clinical variables (n = 43) were coded based on a retrospective chart review. Univariate analysis of variables in relation to recurrent disease was performed by a log-rank test of Kaplan-Meier estimates. Multivariate analysis was performed using Cox proportional hazards modeling. Variables with P < .2 on univariate analysis were included in a stepwise selection algorithm. RESULTS: The study population included 672 patients; mean age, 61 ± 15 years; mean follow-up, 42.8 ± 24 months. The index presentation of diverticulitis was most commonly located in the sigmoid colon (72%), followed by descending colon (33%), right colon (5%), and transverse colon (3%). Overall recurrence at 5 years was 36% by (95% CI 31.4%–40.6%) Kaplan-Meier estimate. Complicated recurrence (fistula, abscess, free perforation) occurred in 3.9% (95% CI 2.2%–5.6%) of patients at 5 years by Kaplan-Meier estimate. Family history of diverticulitis (HR 2.2, 95% CI 1.4–3.2), length of involved colon >5 cm (HR 1.7, 95% CI 1.3–2.3), and retroperitoneal abscess (HR 4.5, 95% CI 1.1–18.4) were associated with diverticulitis recurrence. Right colon disease (HR 0.27, 95% CI 0.09–0.86) was associated with freedom from recurrence. CONCLUSION: Although diverticulitis recurrence is common following an initial attack that has been managed medically, complicated recurrence is uncommon. Patients who present with a family history of diverticulitis, long segment of involved colon, and/or retroperitoneal abscess are at higher risk for recurrent disease. Patients who present with right-sided diverticulitis are at low risk for recurrent disease. These findings should be taken into consideration when counseling patients regarding the potential benefits of prophylactic colectomy.

Early multi-institution experience with single-incision laparoscopic colectomy.

PURPOSERecent studies have suggested that a subset of patients with Crohn’s colitis may have a favorable outcome after ileal pouch-anal anastomosis and have advocated elective ileal pouch-anal anastomosis in selected patients with Crohn’s disease. We have not offered ileal pouch-anal anastomosis to patients with known Crohn’s disease, but because of the overlap in clinical presentation of ulcerative colitis and indeterminate colitis, some patients receiving an ileal pouch-anal anastomosis are subsequently found to have Crohn’s disease. We review our experience with these patients to identify potential preoperative predictors of ultimate pouch failure.METHODSPatients with a final diagnosis of Crohn’s disease were identified from an ileal pouch-anal anastomosis registry. These patients are followed prospectively. Preoperative and postoperative clinical and pathologic characteristics were evaluated as predictors of outcome. Median (range) values are listed.RESULTSThirty-two (18 females) patients (4.1 percent) with a final diagnosis of Crohn’s disease were identified from a registry of 790 ileal pouch-anal anastomosis patients (1980–2002). Patients underwent ileal pouch-anal anastomosis in two stages (11 patients) or three stages (21 patients). The preoperative diagnosis was ulcerative colitis in 24 patients and indeterminate colitis in 8 patients. Median follow-up was 153 (range, 13–231) months. The median time from ileal pouch-anal anastomosis to diagnosis of Crohn’s disease was 19 (range, 0–188) months. Complications occurred in 93 percent, including perineal abscess/fistula (63 percent), pouchitis (50 percent), and anal stricture (38 percent). Pouch failure (excision or current diversion) occurred in nine patients (29 percent) at a median of 66 (range, 6–187) months. Two of these 9 patients had preoperative anal disease (not significant). Comparing patients with failed pouches (n = 9) to patients with functioning pouches (n = 23), post-ileal pouch-anal anastomosis perineal abscess (67 vs. 26 percent, P = 0.05) and pouch fistula (89 vs. 30 percent, P = 0.01) were more commonly associated with pouch failure. Preoperative clinical, endoscopic, and pathologic features were not predictive of pouch failure or patient outcome. For those with a functional pouch, 50 percent have been or are currently on medication to treat active Crohn’s disease. This group had six bowel movements in 24 (range, 3–10) hours, with leakage in 60 percent and pad usage in 45 percent.CONCLUSIONSPatients who undergo ileal pouch-anal anastomosis and are subsequently found to have Crohn’s disease experience significant morbidity. Preoperative characteristics, including the presence of anal disease, were not predictive of subsequent pouch failure. We choose not to recommend the routine application of ileal pouch-anal anastomosis in any subset of patients with known Crohn’s disease.

Laparoscopic total colectomy for acute colitis

PURPOSE: Single-incision laparoscopic colectomy represents a potential advance in minimally invasive surgical approaches to colorectal disease. Although widely promoted, outcome data are virtually absent. A group of highly experienced laparoscopic attending colorectal surgeons convened to standardize technique and prospectively record operative details and outcomes. METHODS: Single-incision laparoscopic colectomy was performed by 10 experienced attending colorectal surgeons with minimal or no prior single-incision laparoscopic colectomy experience. Surgeon rating of ergonomics and 15 components of operation conduct was compared with conventional multiple-port laparoscopic colectomy. Patient demographics, operative details, and outcome data were prospectively collected. RESULTS: Thirty-nine single-incision laparoscopic colectomies were performed (25 right colectomies, 5 ileocolic resections, 8 sigmoidectomies, and 1 low anterior resection). Underlying pathology included polyps (12), cancer (15), Crohns disease (5), and diverticulitis (7). Patients were highly selected with a mean body mass index of 25.6 (range, 16–40). Two conversions to open resection occurred, 1 because of fistula and 1 because of adhesions, in patients with a mean body mass index of 34. An additional port was required in 3 patients. Mean incision length was 4.2 cm (range, 2.5–8) and operative time was 120 minutes (range, 68–210). Complications included 1 wound infection and 2 anastomotic bleeds requiring transfusion. Average length of stay was 4.4 days (range, 2–8). Mean lymph node harvest was 19 (range, 12–39). Exposure, instrument conflict, ergonomics, ease of instrumentation, and camera operation were rated significantly more difficult with single-incision laparoscopic colectomy than with multiple-port laparoscopic colectomy. CONCLUSIONS: Preliminary data demonstrate that single-incision laparoscopic colectomy can be performed safely in selected patients by experienced surgeons. The benefits of single-incision compared with multiple-port laparoscopic colectomy are not immediately evident. Despite the advanced skills of the faculty, a learning curve of undetermined length still exists in which specific components of single-incision laparoscopic colectomy are more difficult than multiple-port laparoscopic colectomy, and areas of focus remain that require advances to make single-incision laparoscopic colectomy equivalent to multiple-port laparoscopic colectomy. The multi-institutional registry will enable further analysis of single-incision laparoscopic colectomy.

Laparoscopic Surgery of the Colon and Rectum

INTRODUCTION: There are no previous comparative studies of total abdominal colectomy by laparoscopic methods in ulcerative colitis and Crohns disease patients requiring urgent colectomy. This study aimed to determine the safety and efficacy of laparoscopic colectomy in these patients compared with those undergoing conventional urgent colectomy. METHODS: Patients undergoing laparoscopic total colectomy for acute colitis were identified in a prospective registry. All patients underwent a total colectomy with creation of an end ileostomy and buried mucous fistula. No patient had fulminant disease (tachycardia, fever, marked leukocytosis, peritonitis), but all were failing to respond to medical treatment. Patients undergoing conventional total colectomy were matched for age, gender, body mass index, diagnosis, disease severity, and operative period. Median values (range) are listed. RESULTS: From 1997 to 1999, there were 19 laparoscopic and 29 matched conventional patients. There were no inadvertent colotomies or conversions in the laparoscopic group. Although there was no difference in operative blood loss in the laparoscopic group (100 (range, 50–700) ml) when compared with the conventional group (150 (range, 50–500) ml), the operative times were significantly longer in the laparoscopic group (210 (range, 150–270)vs. 120 (range, 60–180) minutes,P<0.001). Bowel function returned more quickly in the laparoscopic group (1 (range, 1–3)vs. 2 (range, 1–4) days;P=0.003) and the length of stay was shorter (4 (range, 3–13)vs. 6 (range, 4–24) days;P=0.04). Complications occurred in three (16 percent) laparoscopic patients (2 wound infection and 1 ileus) and in seven (24 percent) conventional patients (3 wound infection, 3 deep venous thrombosis, 1 upper gastrointestinal bleed). CONCLUSIONS: Laparoscopic total colectomy is feasible and safe in patients with acute nonfulminant colitis and may lead to a faster recovery than conventional resection.