The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip.

BACKGROUND: To evaluate the effectiveness and safety of the DS Titanium Ligation Clip for appendicular stump closure in laparoscopic appendectomy. METHODS: Overall, 502 patients undergoing laparoscopic appendectomy were recruited for this observational multicentre study in nine study centres between October 2011 and July 2013. The clip was finally applied in 390 patients. Primary outcome variables were feasibility of the clip, intra-abdominal surgical site (abscesses, stump leakages) and superficial wound infections. Patients were followed 30 days after surgery. RESULTS: The clip was applicable in nearly 80 % of patients. Reasons for not applying the clip were mainly an inflamed caecum or a too large diameter of the appendix base. Superficial wound infections were found in nine (2.31 %), intra-abdominal abscesses in five (1.28 %), appendicular stump leak in one (0.26 %), and other adverse events in 22 (5.64 %) patients. In total, 12 (3.08 %) patients were re-admitted to hospital for treatment. Seven re-admissions were surgery-related; ten (2.56 %) patients had to be re-operated. One patient died during the course of the study due to persisting peritonitis (mortality 0.26 %). CONCLUSIONS: The results suggest that the DS Titanium Ligation Clip is a safe and effective option in securing the appendicular stump in laparoscopic appendectomy. The complication rates found with the use of the DS-Clip are comparable to the rates in the literature when other methods are used. TRIAL REGISTRATION: NCT01734837 .

Oncologic colorectal resection after endoscopic treatment of malignant polyps: does endoscopy have an adverse effect on oncologic and surgical outcomes?

BACKGROUND: Early colorectal cancer is increasingly treated by endoscopic removal. In cases of incomplete resection or high-risk carcinoma, additional surgery is necessary. OBJECTIVE: To evaluate the frequency of subsequent oncologic surgery after endoscopic resection of colorectal cancer, the rate of lymph node metastasis, residual cancer, and morbidity and mortality rates of the operation. Any eventual adverse effect of the prior endoscopic therapy on the surgical and oncologic outcome was assessed. DESIGN: Retrospective review of prospectively collected data. SETTING: University hospital. PATIENTS: Sixty-six consecutive patients with incomplete endoscopic treatment and need for additional surgery between 2004 and 2011. INTERVENTION: The data of these patients were compared with those of a group of patients with surgery for early colorectal cancer during the same period without prior endoscopic resection as the control group. MAIN OUTCOME MEASUREMENTS: Rate of lymph node metastasis and residual cancer, perioperative morbidity and mortality. RESULTS: The lymph node metastasis rate after oncologic resection was 8.6%, and the residual cancer rate was 41%. Risk factors for residual cancer were macroscopic incomplete resection (P < .0001), positive resection margins (P = .03), and piecemeal resection (P = .004). No mortality was observed. Perioperative morbidity, mortality, and oncologic outcome were not significantly different in the group with prior endoscopic resection compared with the primarily operated group. LIMITATIONS: Retrospective study. CONCLUSION: Endoscopic treatment of malignant polyps does not worsen surgical and oncologic outcomes in cases of subsequent surgery. Because mortality and morbidity are low, oncologic resection generally should be done in the presence of risk factors for residual cancer.

Influence of conversion on the perioperative and oncologic outcomes of laparoscopic resection for rectal cancer compared with primarily open resection.

BACKGROUND: This study aimed to evaluate the influence of conversion on perioperative and short- and long-term oncologic outcomes in laparoscopic resection for rectal cancer and to compare these with those for an open control group. METHODS: The data of 276 consecutive patients who underwent surgery for rectal cancer between 2006 and 2010 at a single institution were prospectively collected. Of the 276 patients, 114 underwent primarily open surgery, and 162 underwent laparoscopic surgery (on an intention-to-treat basis). Of the 162 laparoscopic patients, 38 (23.5%) underwent conversion to open surgery. The three groups of patients were compared: the conversion surgery group, the open surgery group, and the completed laparoscopy surgery group. RESULTS: The converted patients had more wound infections (18.4 vs 4.8%, p = 0.009), but the wound infection rate in the primarily open group also was significantly higher than in the laparoscopic resection group (p = 0.007). No further differences in perioperative morbidity, including anastomotic leakage, were found. The perioperative 30-day mortality rate was comparable between all the groups (0.6 vs 2.6 vs 2.6%, nonsignificant difference). The oncologic parameters such as number of harvested lymph nodes and rate of R0 resection were equal in all the groups. The completed laparoscopy group had a shorter hospital stay [12 vs 16 days in the primarily open group (p = 0.02) vs 15 days in the converted group (p = 0.03)]. The rates for survival, local recurrence (4.5 vs 3 vs 3%), and metachronous metastasis (10.1 vs 9.3 vs 9%) did not differ significantly between the three groups after a period of 3 years. CONCLUSION: Conversion to open surgery in laparoscopic rectal resection has no negative effect on perioperative or long-term oncologic outcome.

Appendix stump closure with titanium clips in laparoscopic appendectomy.

PURPOSE: Different techniques, including clips, have been used to close the stump in laparoscopic appendectomy. The aim was to investigate the results after application of a newly developed titanium clip for this operation. METHODS: From June 2008 to February 2010, 104 patients from two different hospitals undergoing laparoscopic appendectomy were included in this prospective study. Closure of the appendix base was generally intended with a titanium double-shanked clip (DS-Clip). The variables of interest were intra-and postoperative complications, operation time and hospital stay. Furthermore, an evaluation of the clip's practicability by the surgeon was performed using a standardised questionnaire. RESULTS: In 104 patients screened intraoperatively, four patients had to be excluded as the operating surgeon felt that the clip was not adequate for closing the stump, generally because of severe inflammation of the base of the appendix with involvement of the caecum. One patient developed an intra-abdominal abscess which had to be drained interventionally; no reoperations were necessary. The overall complication rate, the operation time and the hospital stay were well comparable with other devices for appendix stump closure such as staplers, loops or polymeric clips. The practicability of the clip was mainly rated as excellent or good by the operating surgeons. CONCLUSION: This study suggests that the presented titanium DS-Clip is a safe and cost-effective technique for securing the appendix base in laparoscopic appendectomy. The application is easy and can be learned quickly, making it a good option also for teaching hospitals.

Protection from colorectal cancer after colonoscopy: a population-based, case-control study.

BACKGROUND: Colonoscopy with detection and removal of adenomas is considered a powerful tool to reduce colorectal cancer (CRC) incidence. However, the degree of protection achievable in a population setting with high-quality colonoscopy resources remains to be quantified. OBJECTIVE: To assess the association between previous colonoscopy and risk for CRC. DESIGN: Population-based case-control study. SETTING: Rhine-Neckar region of Germany. PATIENTS: A total of 1688 case patients with colorectal cancer and 1932 control participants aged 50 years or older. MEASUREMENTS: A detailed lifetime history of CRC risk factors and preventive factors, including history and results of previous colonoscopies, and of medical data obtained by self-reports and medical records. Odds ratios of CRC associated with colonoscopy in the preceding 10 years were estimated, after adjustment for sex, age, education level, participation in a general health screening examination, family history of CRC, smoking status, body mass index, and use of nonsteroidal anti-inflammatory drugs or hormone replacement therapy. RESULTS: Overall, colonoscopy in the preceding 10 years was associated with 77% lower risk for CRC. Adjusted odds ratios for any CRC, right-sided CRC, and left-sided CRC were 0.23 (95% CI, 0.19 to 0.27), 0.44 (CI, 0.35 to 0.55), and 0.16 (CI, 0.12 to 0.20), respectively. Strong risk reduction was observed for all cancer stages and all ages, except for right-sided cancer in persons aged 50 to 59 years. Risk reduction increased over the years in both the right and the left colon. LIMITATION: The study was observational, with potential for residual confounding and selection bias. CONCLUSION: Colonoscopy with polypectomy can be associated with strongly reduced risk for CRC in the population setting. Aside from strong risk reduction with respect to left-sided CRC, risk reduction of more than 50% was also seen for right-sided colon cancer. PRIMARY FUNDING SOURCE: German Research Council and German Federal Ministry of Education and Research.

Laparoscopic surgery for rectal prolapse and pelvic floor disorders.

Pelvic floor disorders are different dysfunctions of gynaecological, urinary or anorectal organs, which can present as incontinence, outlet-obstruction and organ prolapse or as a combination of these symptoms. Pelvic floor disorders affect a substantial amount of people, predominantly women. Transabdominal procedures play a major role in the treatment of these disorders. With the development of new techniques established open procedures are now increasingly performed laparoscopically. Operation techniques consist of various rectopexies with suture, staples or meshes eventually combined with sigmoid resection. The different approaches need to be measured by their operative and functional outcome and their recurrence rates. Although these operations are performed frequently a comparison and evaluation of the different methods is difficult, as most of the used outcome measures in the available studies have not been standardised and data from randomised studies comparing these outcome measures directly are lacking. Therefore evidence based guidelines do not exist. Currently the laparoscopic approach with ventral mesh rectopexy or resection rectopexy is the two most commonly used techniques. Observational and retrospective studies show good functional results, a low rate of complications and a low recurrence rate. As high quality evidence is missing, an individualized approach is recommend for every patient considering age, individual health status and the underlying morphological and functional disorders.

A modified ex vivo human whole blood model of infection for studying the pathogenesis of Neisseria meningitidis during septicemia.

For the purpose of establishing a model to study host-bacteria interaction and virulence mechanisms of Neisseria meningitidis during the septic phase of disease a modified human whole blood model of infection is proposed. Compared to published whole blood models the current model was modified with respect to the initial number of viable bacteria (10(4) cfu ml(-1)), the anticoagulant used and the incubation time. The results obtained after incubation of a number of human blood samples from healthy volunteers for 24 h with serogroup B meningococci were in good agreement with findings reported from patients who suffered severe meningococcal disease.

Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study.

PURPOSE: Empirical evidence for recommendations of surveillance intervals after detection and removal of adenomas at colonoscopy is still sparse and mostly based on observations of adenoma recurrence. We aimed to assess risk of colorectal cancer (CRC) according to time since polypectomy and factors that might be relevant for risk stratification. METHODS: In a population-based case-control study conducted in Germany, detailed history and results of previous large-bowel endoscopies were obtained by interview and from medical records. Risk of CRC among participants with detection of at least one adenoma at a preceding colonoscopy compared with participants without previous large-bowel endoscopy was assessed according to time since polypectomy among 2,582 cases with CRC and 1,798 matched controls. RESULTS: Adjusted odds ratios (95% CIs) of CRC for participants with polypectomy less than 3, 3 to 5, and 6 to 10 years ago (using participants without previous endoscopy as reference group) were 0.2 (0.2 to 0.3), 0.4 (0.3 to 0.6), and 0.9 (0.5 to 1.5), respectively. Strong, significant risk reduction within 5 years was consistently seen for women and men, younger and older participants, patients with and without high-risk polyps (three or more polyps, at least one polyp ≥ 1 cm, at least one polyp with villous components), and those with and without polypectomy in the right colon. With adjusted odds ratios of 0.1 (0.1 to 0.2), 0.3 (0.2 to 0.5) and 0.4 (0.2 to 0.8) for patients with polypectomy less than 3, 3 to 5, and 6 to 10 years ago, risk reduction was particularly strong for left-sided CRC. CONCLUSION: Extension of surveillance intervals to 5 years should be considered, even after detection and removal of high-risk polyps.