Long-Term Effects of Omitting Antibiotics in Uncomplicated Acute Diverticulitis.

BACKGROUND: Traditionally uncomplicated acute diverticulitis was routinely treated with antibiotics, although evidence for this strategy was lacking. Recently, two randomized clinical trials (AVOD trial and DIABOLO trial) published short-term results of omitting antibiotics compared to routine antibiotic treatment. Both showed no significant differences regarding recovery from the initial episode, as well as rates of complicated or recurrent diverticulitis and sigmoid resection. However, both studies showed a trend of higher rates of sigmoid resection in the observational groups. Here, the long-term effects of omitting antibiotics in first episode uncomplicated acute diverticulitis were assessed. METHODS: A total of 528 patients with CT-proven, primary, left-sided, uncomplicated acute diverticulitis were randomized to either an observational or an antibiotic treatment strategy (DIABOLO trial). Outcome measures were complicated diverticulitis, recurrent diverticulitis and sigmoid resection at 24 months' follow up. Differences between the groups were explored and risk factors were identified using multivariable logistic regression. RESULTS: Complete case analyses showed no difference in rates of recurrent diverticulitis (15.4% in the observational group versus 14.9% in the antibiotic group; p = 0.885), complicated diverticulitis (4.8% versus 3.3%; p = 0.403) and sigmoid resection (9.0% versus. 5.0%; p = 0.085). Young patients (<50 years) and patients with a pain score at presentation of 8 or higher on a visual analogue pain scale were at risk for complicated or recurrent diverticulitis. In this multivariable analysis, treatment type (with or without antibiotics) was not an independent predictor for complicated or recurrent diverticulitis. CONCLUSION: Omitting antibiotics in the treatment of uncomplicated acute diverticulitis did not result in more complicated diverticulitis, recurrent diverticulitis or sigmoid resections at long-term follow up. As the DIABOLO trial was not powered for these secondary outcome measures, some uncertainty remains whether (small) non-significant differences could be true associations.

Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial).

BACKGROUND: Ileostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life. METHODS: This randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions. RESULTS: Between April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4 versus 41·4 per cent respectively; risk difference 11·0 (95 per cent c.i. 0·3 to 21·2) per cent). Skin irritation rates were high (78·2 versus 72·2 per cent), but did not differ significantly between the groups (risk difference 6·1 (95 per cent c.i. -3·2 to 15·10) per cent). There were no significant differences in quality of life or costs between the groups. CONCLUSION: Intracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 ( http://www.trialregister.nl).

Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis.

BACKGROUND: Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis. METHODS: Patients with CT-proven, primary, left-sided, uncomplicated, acute diverticulitis were included at 22 clinical sites in the Netherlands, and assigned randomly to an observational or antibiotic treatment strategy. The primary endpoint was time to recovery during 6 months of follow-up. Main secondary endpoints were readmission rate, complicated, ongoing and recurrent diverticulitis, sigmoid resection and mortality. Intention-to-treat and per-protocol analyses were done. RESULTS: A total of 528 patients were included. Median time to recovery was 14 (i.q.r. 6-35) days for the observational and 12 (7-30) days for the antibiotic treatment strategy, with a hazard ratio for recovery of 0·91 (lower limit of 1-sided 95 per cent c.i. 0·78; P = 0·151). No significant differences between the observation and antibiotic treatment groups were found for secondary endpoints: complicated diverticulitis (3·8 versus 2·6 per cent respectively; P = 0·377), ongoing diverticulitis (7·3 versus 4·1 per cent; P = 0·183), recurrent diverticulitis (3·4 versus 3·0 per cent; P = 0·494), sigmoid resection (3·8 versus 2·3 per cent; P = 0·323), readmission (17·6 versus 12·0 per cent; P = 0·148), adverse events (48·5 versus 54·5 per cent; P = 0·221) and mortality (1·1 versus 0·4 per cent; P = 0·432). Hospital stay was significantly shorter in the observation group (2 versus 3 days; P = 0·006). Per-protocol analyses were concordant with the intention-to-treat analyses. CONCLUSION: Observational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov).

Nationwide decline in annual numbers of abdomino-perineal resections: effect of a successful national trial?

OBJECTIVE: Large national trials may influence surgical practice. In this study the relation between the successful national randomized trial on the management of rectal cancer (the Dutch TME trial) and national ratio of abdomino-perineal resection to low anterior resection and anastomosis was analysed. PATIENTS AND METHODS: In the study period, 1994-99, 15978 patients underwent either abdomino-perineal resection (n = 2575) or low anterior resection and anastomosis (n = 13403). The Dutch TME trial started in 1996 and a total of 1530 patients were included by 83 hospitals and 82.1% of these patients were treated from 1997 to 1999. Teaching sessions, tutor assisted surgery and quality control formed an integral and important part of the TME trial. RESULTS: Ratio of abdomino-perineal resection vs. low anterior resection was compared between period I (1994-96) and period II (1997-99). The ratio decreased from 0.19 to 0.13 between period I and II (95% CI, -0.08 to -0.04, P < 0.001). In hospital mortality rate did not change between period I and II (3.5 vs. 3.7, 95% CI, -0.08 to 0.03, P=0.385). CONCLUSION: Significant changes in surgical attitude may accompany successful national randomized trials in which investigated surgical procedures are specified, taught, and controlled. The APR ratio declined by 32% in the Netherlands during and following the Dutch TME trial, without a rise in hospital mortality rate for rectal resections.

The influence of CO2 versus helium insufflation or the abdominal wall lifting technique on the systemic immune response.

BACKGROUND: Both laparoscopic and conventional surgery result in activation of the systemic immune response; however, the influence of the laparoscopic approach, using CO2 insufflation, is significantly less. Little is known about the influence of alternative methods for performing laparoscopy, such as helium insufflation and the abdominal wall lifting technique (AWLT), and the systemic immune response. METHODS: Thirty-three patients scheduled for elective cholecystectomy were randomly assigned to undergo laparoscopy using either CO2 or helium for abdominal insufflation or laparoscopy using only the AWLT. The postoperative inflammatory response was assessed by measuring the white blood cell count, C-reactive protein (CRP) and interleukin-6 (IL-6). The postoperative immune response was assessed by measuring monocyte HLA-DR expression. RESULTS: CRP levels were significantly higher 1 day after helium insufflation when compared with CO2 insufflation; however, no differences were observed 2 days after surgery. The AWLT resulted in significantly higher levels of CRP both 1 and 2 days after surgery when compared with either CO2 or helium insufflation. A small increase in postoperative IL-6 levels was observed in all groups, but no significant differences were seen between the groups. After both helium insufflation and AWLT a significant decrease in HLA-DR expression was observed, in contrast to the CO2 group. CONCLUSION: Carbon dioxide used for abdominal insufflation seems to limit the postoperative inflammatory response and to preserve parameters reflecting the immune status. These findings may be of importance in determining the preferred method of laparoscopy in oncologic surgery.

Fissurectomy and isosorbide dinitrate for chronic fissure in ano not responding to conservative treatment.

BACKGROUND: Although lateral sphincterotomy heals chronic fissure in ano in over 90 per cent of cases it is a surgical technique with inherent complications. To avoid such complications, chronic fissure in ano was treated by fissurectomy in this study. To enhance postoperative tissue perfusion allowing stable wound healing, fissurectomy was combined with temporary chemical sphincterotomy by a nitric oxide donor cream. METHODS: Seventeen consecutive patients (ten women) with chronic fissure in ano not responding to conservative management underwent diathermy fissurectomy. After operation patients used a 1 per cent isosorbide dinitrate cream. Postoperative follow-up continued until wounds had healed, at which time anal endosonography was performed. A telephone inquiry into fissure recurrence and continence status was made. RESULTS: Seventeen patients underwent fissurectomy, without postoperative complications. All wounds had healed within 10 weeks. No fissure recurrence was seen after a median follow-up of 29 months. Histopathology showed non-specific scar tissue without signs of internal anal sphincter fibrosis. Postoperative endosonography showed no evidence of new internal sphincter defects. CONCLUSION: In the treatment of chronic anal fissure not responding to chemical sphincterotomy with nitric oxide donors, fissurectomy in combination with isosorbide dinitrate cream may be a sphincter-sparing surgical technique.

The influence of laparoscopic surgery on postoperative polymorphonuclear leukocyte function.

BACKGROUND: Laparoscopic surgery is thought to result in a better preservation of patients' immunological defenses. Polymorphonuclear leukocytes (PMN) are the most important effector cells in the elimination of pathogenic microorganisms. Because little is known about their function after laparoscopic surgery, we studied PMN phagocytosis, antigen expression, and oxygen radical production. METHODS: In this study, 17 patients scheduled for Nissen fundoplication were randomly assigned to undergo either a laparoscopic or conventional procedure. To study phagocytic capacity, PMN were incubated with fluorescein isothiocyanate (FITC)-labeled Staphylococcus aureus. Plasma opsonic capacity was measured by comparing PMN phagocytosis in the presence of patients' own plasma with phagocytosis in the presence of control plasma. Cellular activation was measured by the expression of various cell surface markers and by assessment of PMA-stimulated oxidative burst. RESULTS: Phagocytosis by PMN in the presence of patients' plasma was significantly lower 2 h after the conventional operation. No decrease in phagocytosis was observed when control plasma was used, indicating a decreased opsonic capacity of plasma after conventional surgery. No changes were observed after laparoscopic surgery. Furthermore, CD11b expression was significantly lower after the laparoscopic approach, indicating a blunted cellular activation. A significantly lower PMA-stimulated oxidative burst further confirmed the tempered stimulation after laparoscopic surgery. CONCLUSIONS: Laparoscopic surgery results in a preservation of the plasma opsonic capacity, and thereby the ability of PMN to phagocytose bacteria. Moreover, the postoperative cellular activation is reduced. The preserved phagocytosis and the blunted activation may prevent the development of postoperative infectious complications.

Laparoscopic elective treatment of diverticular disease. A comparison between laparoscopic-assisted and resection-facilitated techniques.

BACKGROUND: Because of the presence of significant inflammatory reaction, elective surgical laparoscopic-assisted treatment of complicated diverticular disease can be difficult, leading to a high conversion and complication rate. Laparoscopic alternatives to this assisted approach consist of the hand-assisted method and the more conventional facilitated laparoscopic sigmoid resection. Facilitated laparoscopic sigmoid resection implies laparoscopic mobilization of the sigmoid as much as possible and splenic flexure when called for. Through a Pfannenstiel incision, the difficult steps of the operation-such as the dissection of the inflammatory process and taking down the fistula, but also resection and manual anastomosis-can be performed. In this study, we compare the operating time, conversion rate, complications, and costs of both assisted and resection-facilitated techniques. METHODS: We compared two consecutive series of 35 patients with diverticular disease who underwent a sigmoid resection by laparoscopy. Both groups were comparable in terms of age, gender, and kind of complicated diverticular disease. RESULTS: The operating time, conversion rate, and costs were all less in the laparoscopic-facilitated group. The fact that there were no conversions in this group is the most important finding of this study. Not only was it possible to convert from the assisted laparoscopic approach to laparotomy (five patients of 35), it was also possible to convert from the assisted to the facilitated form (seven of 35 patients). CONCLUSIONS: Laparoscopic-facilitated sigmoid resection is a feasible intervention for all forms of complicated diverticular disease and yields marked reductions in operating time, conversion rate, and operative and general costs.

Preoperative ERCP approach to common bile duct stones: results of a selective policy.

BACKGROUND: In a previous study, we made a plea for more selective indications for preoperative ERCP in patients with gallstones based on the results obtained from a liberal policy. Following 3.5 years of implementing this selective policy, a report on the results are presented here. This study was performed in a referral academic hospital. METHODS: Between June 1994 and December 1997, 328 patients underwent cholecystectomy because of symptomatic cholelithiasis. Absolute indications for preoperative ERCP were: acute cholangitis (4 patients); obstructive jaundice (22 patients); gallstone pancreatitis (within the first 24 h in 14 patients), and wide common bile duct (CBD, >8 mm) with suspicion of stones in the biliary tree (2 patients). RESULTS: In 42 patients (12.8%) a preoperative ERCP was performed for these indications. Stones were found in the CBD in 30 patients and edema in the papilla in 2 patients (total 76.2%). The stones could be extracted by endoscopic sphincterotomy in 24 of the 30 patients (80%). Complications were seen in 7 patients (16.7%). All these complications (bleeding of the papilla in 4 and mild pancreatitis in 3 patients) could be treated conservatively. During a mean follow-up of 2.5 years, CBD stones could be demonstrated postoperatively in 3 patients (0.3%). No mortality was observed in this series. CONCLUSIONS: The results of this selective policy included the expected outcome of a significant reduction in the number of ERCPs performed from 29 to 12.8% (p < 0.001, chi(2) test) and a better yield of stones, from 29 to 76.2% of the patients. The mortality of the procedure decreased from 2 to 0% whereas morbidity remained the same. This selective policy seems adequate for the preoperative assessment of CBD stones.

Laparoscopic surgery preserves monocyte-mediated tumor cell killing in contrast to the conventional approach.

BACKGROUND: Experimental animal research shows that immunologic defenses against tumor cells are disturbed by surgical trauma, resulting in an increased rate of tumor implantation and the growth of subsequent metastases. Minimally invasive surgery is associated with a preservation of postoperative immunologic functions and, in animal models, with decreased tumor growth. The objective was to study the influence of several surgical procedures, approached conventionally and laparoscopically, on interleukin-6 (IL-6) and monocyte-mediated cytotoxicity (MMC). METHODS: Five groups of five patients each were included in this prospective study: laparoscopic cholecystectomy (minor trauma) group, Nissen fundoplication (laparoscopic and conventional as moderate trauma) groups, and sigmoid colectomy (laparoscopic and conventional as major trauma) groups. Preoperatively, 1 and 4 days after surgery, IL-6 and MMC against SW948 colon cancer cell line were determined. RESULTS: The IL-6 levels differed significantly between the three laparoscopic procedures (p = 0.004) and increased according to the degree of trauma. There was no significant difference in MMC between the three laparoscopic procedures. However, MMC was suppressed after conventional procedures and preserved after laparoscopic procedures (p = 0.001). There was no correlation between IL-6 levels and changes in MMC. CONCLUSIONS: More extensive laparoscopic procedures induce increased levels of IL-6, reflecting higher levels of trauma. Conventional surgical procedures result in depressed MMC in the postoperative period. After laparoscopic procedures, MMC is preserved. These findings may be of importance in preventing implantation and growth of cancer cells spread by surgical manipulation.

[Same-day diathermic hemorrhoidectomy in 48 patients; few complications and tolerable pain]. / Diathermische hemorroïdectomie in dagopname bij 40 patiënten: weinig complicaties en draaglijke pijn.

OBJECT: To measure pain characteristics and to ascertain patient satisfaction and level of complications after day-care haemorrhoidectomy. DESIGN: Prospective. METHOD: Diathermic haemorrhoidectomy was performed in daytime care in 40 successive patients in hospital De Heel, Zaandam in 1997-1998. The operation was part of a package of measures, such as extensive counseling, preoperative bulking agents, surgery performed by colorectal surgeon, dedicated anaesthesiological techniques, adequate pain medication, and frequent outpatient clinic visits. RESULTS: The 40 patients were 21 men and 19 women with a mean age of 43 years (range: 27-67). One male patient was admitted for 24 hours because of urinary retention and 1 female patient developed a wound infection. No other serious complications were seen. During the first 5 postoperative bowel movements 75% of the total pain score was obtained. Postdefaecatory pain lasted on average 81 min on day 1 to 8 min on day 7. Time away from work was on average 6.4 days (range: 0-12). In between clinic visits 5 patients consulted their general practitioners. After 6 weeks 95% of the patients would again have consented to day-care haemorrhoidectomy. CONCLUSION: Diathermic haemorrhoidectomy has a low complication rate and tolerable pain and can be performed in day care.

Laparoscopic treatment of large paraesophageal hernias: both excision of the sac and gastropexy are imperative for adequate surgical treatment.

BACKGROUND: We set out to evaluate the results of the laparoscopic treatment of large paraesophageal hernias in 22 patients. METHODS: Between 1993 and 1998, we operated on 22 consecutive patients. Preoperative assessment consisted of endoscopy, barium esophagogram, 24-h pH testing, manometry, and gastric emptying times. RESULTS: In the first three patients, the sac was not excised and gastropexy was not performed. Because of recurrences, we decided to change the technique in an attempt to avoid further complications. During middle- to long-term follow-up, only three recurrences were seen in the subsequent 19 patients. There were no deaths in this series. CONCLUSIONS: Laparoscopic treatment of large paraesophageal hernias is feasible. Because recurrences may occur after successful laparoscopic treatment, both resection of the sac and some form of gastropexy are imperative.

Laparoscopically assisted bowel surgery for inflammatory bowel disease. The combined experiences of two academic centers.

BACKGROUND: Laparoscopic bowel surgery was evaluated in 44 consecutive patients who underwent surgery for inflammatory bowel disease (IBD). We studied feasibility, results, and final outcome. METHODS: At two academic institutes, 44 laparoscopically assisted colectomies and laparoscopic ileostomies or colostomies were attempted. All patients had histologically proven IBD and no prior surgery for IBD. Loop ileostomy (n = 4), end colostomy (n = 1), ileocecal resection (n = 26) and (procto)colectomy (n = 13) were performed. All resections were laparoscopically assisted with extracorporal resection and anastomosis. RESULTS: Only in two patients (ileocecal resection in both) was conversion to open surgery necessary. Two patients with laparoscopic ileocolic resection had intra-abdominal abscesses, which were drained percutaneously in both. One patient in the laparoscopically assisted colectomy group had a subphrenic abscess that was drained percutaneously, and one patient had a generalized candidiasis. CONCLUSIONS: Laparoscopically assisted colectomies can be performed safely in treating IBD. The laparoscopic method with use of a small vertical umbilical or Pfannenstiel's incision seems acceptable with regard to operating time and overall costs, also allowing superior cosmesis to be maintained.

A prospective randomized study of the systemic immune response after laparoscopic and conventional Nissen fundoplication.

BACKGROUND: Laparoscopic techniques are thought to reduce the postoperative immunologic and metabolic changes of conventional operations. Until now, the only clinical data available were obtained from patients operated on for symptomatic gallstones; moreover, few studies were randomized. This randomized prospective study compares the systemic immune response after laparoscopic and conventional Nissen fundoplication. METHODS: Seventeen patients scheduled for Nissen fundoplication were randomly assigned to undergo either a laparoscopic or a conventional procedure. Postoperative inflammatory response was assessed by measuring the white blood cell count, C-reactive protein, and soluble tumor necrosis factor receptors p55 and p75. Postoperative immune function was assessed by measuring monocyte HLA-DR expression and the stress response was assessed by measuring plasma cortisol concentrations. RESULTS: Laparoscopic surgery resulted in significantly lower plasma CRP levels 1 day after surgery. Both approaches resulted in a significant decrease in HLA-DR expression within 2 hours after surgery. After the laparoscopic approach, postoperative expression was restored to preoperative values within 1 day after surgery. However, after conventional surgery HLA-DR expression remained suppressed and did not return to preoperative values until the fourth postoperative day. No significant differences between the 2 procedures were observed in white cell blood count, sTNFr-p55 and p75, nor in postoperative cortisol levels. CONCLUSIONS: Although both laparoscopic and conventional Nissen fundoplication result in an activation of the systemic immune response, this study suggests that this response could be less after the laparoscopic approach. The differences found may reflect a lower risk for postoperative infective complications.

Assessment of the biliary tract by ultrasonography and cholangiography during laparoscopic cholecystectomy: a prospective study.

OBJECTIVE: The introduction of laparoscopic cholecystectomy (Lap-chol) has induced routine cholangiography to map the biliary tree and identify common bile duct (CBD) stones. However, the use of more selective criteria for performing intraoperative cholangiography (IOC), drawbacks of IOC and experience with laparoscopic ultrasonography (LU) re-introduced intraoperative ultrasonography for the CBD. The purpose of this study was to compare the accuracy of LU and IOC to identify the anatomy of the CBD and the presence of stones. METHODS: A total of 50 unselected patients undergoing elective laparoscopic cholecystectomy were evaluated by LU and IOC. Stones were found in three patients by IOC and could be confirmed by ultrasonography and CBD exploration in two. RESULTS: Anatomic definition of the biliary tract and success of the procedure was better for LU (90 and 98%) than IOC (86 and 72%). CONCLUSION: For Surgical groups with experience in LU this technique appears to become the standard technique to identify the anatomy of the CBD and assessment of CBD stones.

Laparoscopic surgery in the treatment of colonic polyps.

BACKGROUND: Benign colonic polyps that are impossible to remove with the aid of the flexible colonoscope because of their size or location must be removed surgically. METHODS: Twenty patients with colonic adenomatous polyps that could not be resected by colonoscopy because of size or difficult location (n = 18) or polyps in combination with diverticulitis (n = 2) underwent polyp removal through a small 'assisted' incision in the abdominal wall using a standard 'dissection-facilitated' laparoscopic approach to the affected colonic segment. RESULTS: In six patients the polyp was removed through a colotomy, in three through a limited resection (two ileocaecal and one limited sigmoid resection) and in 11 through a standard colectomy (four right hemicolectomy, one left hemicolectomy, four sigmoid and two anterior resections) because of suspicion of cancer. In only one patient could the polyp not be found during laparoscopy, resulting in a second conventional surgical intervention. In four patients carcinoma was diagnosed in the specimen. CONCLUSION: Precise preoperative localization of the polyp and the use of dissection-facilitated laparoscopic colonic surgery make laparoscopic removal of benign colonic polyps an alternative to an open procedure.

Laparoscopic rectosigmoid colpopoiesis: does it benefit our transsexual patients?

When inversion of the combined penile and scrotal skin flaps for vaginoplasty in male-to-female transsexuals has not led to functional results, rectosigmoid colpopoiesis offers an immediate solution to a complicated and difficult problem. However, open colocolpopoiesis involves major surgery, and it may be associated with substantial extended morbidity and hospitalization, short- and long-term unfavorable results, and extensive scarring of the abdomen. To reduce this associated morbidity, we employ a laparoscopically assisted approach and a total laparoscopic rectosigmoid colpopoiesis. This procedure has been performed safely in the series presented herein, with no apparent compromise in the adequacy of the dissections. We conclude that our patients benefited from this procedure, and we advocate considering a total or partial laparoscopic approach whenever secondary rectosigmoid colpopoiesis is indicated in male-to-female transsexuals.