Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Short- and long-term outcomes after colorectal anastomotic leakage is affected by surgical approach at reoperation.

BACKGROUND: Anastomotic leakage is the most serious surgical complication following colorectal resection, and surgical intervention is often required. The purpose of the study was to investigate short- and long-term outcomes after reoperation for anastomotic leakage. METHOD: Patients with a symptomatic anastomotic leakage following a laparoscopic colorectal cancer resection from January 2009 to December 2014 were identified from our local prospective database. Patients were grouped according to the management of anastomotic leaks: local, lap, or open approach. Primary outcomes were length of stay, chance of bowel continuity, and overall mortality. RESULTS: A total of 113 patients were included. The median follow-up time was 40 months (0-82 months). Overall mortality was significantly associated with UICC stage III-VI disease (vs. UICC stage I-II disease) [adj. HR 5.35 (CI 2.32-12.4), p = 0.0001] and minimal invasive reoperation compared with open approach [local: adj. HR 0.12 (CI 0.03-0.52), p = 0.004; lap: adj. HR 0.32 (CI 0.12-0.86), p = 0.024]. Chance of bowel continuity was significantly increased in younger patients below 67 years [adj. OR 6.15 (1.76-21.5), p = 0.004] and following a local procedure [adj. OR 7.45 (1.07-51.8), p = 0.043]. Patients in the open group had significantly longer length of stay and time to initiation of adjuvant chemotherapy compared with those in the lap group. CONCLUSION: Our data confirms that minimal invasive reoperation for anastomotic leakage is a safe and feasible approach associated with short- and long-term advantages and can be chosen in selected cases.

Combined laparoscopic and transanal total mesorectal excision for rectal cancer: Initial experience and early results.

INTRODUCTION: Incomplete specimens resulting in residual mesorectum in the patient and an increased risk of local recurrence remains a problem. We have introduced transanal-total mesorectal excision (Ta-TME) in our department to potentially overcome this problem due to more direct access to the lower pelvis in patients undergoing TME for rectal cancer and this article presents our initial experience with the new procedure. MATERIALS AND METHODS: Patients with a T1-T3 mid or low rectal cancer eligible for TME or intersphincteric abdominoperineal excision were selected for a combined transanal and transabdominal laparoscopic resection. The primary aim of the study was to evaluate the feasibility and efficacy of the method with a special focus on the quality of the specimen. RESULTS: During a 9-month period, 11 patients were operated with this technique. All procedures resulted in complete or nearly complete specimen. We did, however, find the procedure technically demanding and experienced several complications with three anastomotic leaks (all with preserved intestinal continuity) and a urethral lesion. CONCLUSION: Ta-TME is feasible and might be the answer to obtaining good quality specimens and overcome some of the technical difficulties that can be encountered in the obese narrow male pelvis. The procedure however is technically demanding.

Total mesocolic excision versus traditional resection in right-sided colon cancer - method and increased lymph node harvest.

INTRODUCTION: Rectal surgery has followed a steady trend towards improved surgical techniques over the past 15 years. Danish colon cancer surgery has not witnessed similar progress. Hohenberger described a comprehensive method involving complete excision of all mesocolic tissue which is equivalent to right-sided hemicolectomy. The present work describes the difference between the traditional surgical method and the comprehensive method, and provides detail on the outcome in 11 patients with regard to morbidity, mortality and lymph node status. MATERIAL AND METHODS: Eleven cases with tumours located orally to the right flexure were included in the study. Surgery was performed using the comprehensive method. After excision of the specimen, the surgeon determined and marked-up the extra central part of the mesentery which had been excised. A pathologist examined the specimen. The extra mesentery segment was independently examined, described and embedded for microscopy, mortality rate, major adverse cardiovascular events, symptom relief and quality-of-life at six-month follow-up. RESULTS: Lymph nodes were found in the extra segment of all specimens, and in two patients the extra segment contained malignant lymph nodes. We found twelve or more lymph nodes in all specimens. Without the extra specimen segment, this would not have been possible in five of the patients. CONCLUSION: Our finding of centrally located lymph nodes confirms Hohenberger's claim that the probability of successful macro-radical removal increases with the removal of such lymph nodes, and removal of as many lymph nodes as possible should generally be considered beneficial to the patient.

[The value of using fluoroscopy during colonoscopy. A prospective randomized study]. / Vaerdien af brug af røntgengennemlysning under udførelse af koloskopi. En prospektiv randomiseret undersøgelse.

INTRODUCTION: No randomised trials have estimated the value of using fluoroscopy for colonoscopy. The aim of our study was to estimate the rate of success using this method. MATERIAL AND METHODS: In a prospective trial 264 patients were included, 139 were examined without fluoroscopy-equipment (Group A), and 125 with fluoroscopy-equipment (Group B). We registered: Indication for colonoscopy, duration of the colonoscopy, medication, time in which X-ray was being used, whether coecum was reached or not, clinical results of the examinations and complications. In cases where coecum was not intubated the cause was registered. RESULTS: We found a significantly higher rate of success of the colonoscopy in Group B (84%) than in group A (74%) (p = 0.045). Pain and looping of the scope were the main reasons for insufficient examination. DISCUSSION: In a modern endoscopic ward fluoroscopy must be available, but it seems reasonable to start uncomplicated colonoscopies without the use of fluoroscopy. In cases where coecal intubation is not obtained, conversion to examination with fluoroscopy should be possible.

A minority of patients discharged within 24 hours after laparoscopic colon resection.

INTRODUCTION: Fast-track laparoscopic colon surgery has gained wide acceptance worldwide. Post-operative hospital stays of 2-5 days have typically been reported. However, in our department some of the patients have been discharged within 24 h after surgery. The aim of this study was to describe differences in demographic and perioperative data between those patients discharged within 24 h and those discharged on days 2-4 post-operatively. MATERIAL AND METHODS: Data were collected retrospectively from August 2008 to May 2012. A total of 24 patients undergoing elective right-sided hemicolectomy or sigmoidectomy for colon cancer were discharged within 24 h. These 24 patients were compared with 209 patients undergoing the same procedures, but discharged on the second to the fourth post-operative day. All patients were operated laparoscopically according to our fast-track regimen. Demographic data and short-term outcomes were compared between the two groups. RESULTS: We found that the median age (64 years versus 70 years) (p = 0.018) as well as the median operating time (120 min. versus 155 min.) (p = 0.002) were significantly lower for the 24-h stay group. No other significant differences were found between the two groups. CONCLUSION: This study showed that discharge within the first 24 h after elective laparoscopic fast-track colon surgery was significantly associated with lower age and shorter duration of surgery. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Is laparoscopic colorectal cancer surgery in obese patients associated with an increased risk? Short-term results from a single center study of 425 patients.

INTRODUCTION: In laparoscopic colorectal cancer surgery, some authors still report increased conversion rates, operative duration and postoperative morbidity with longer hospital stay in obese patients. In our department, we had the impression that laparoscopic surgery in the obese was feasible and safe, leading to this study in which we evaluate laparoscopic surgery for colorectal cancers in the obese and measure the impact on short-term results. MATERIAL AND METHODS: In the period from November 2004 to May 2010, 425 patients were laparoscopically operated for a colon or rectal cancer in our center. Ninety-three patients had a body mass index (BMI) ≥ 30. Demographic data and short-term outcome in patients with a BMI ≥ 30 were compared to the same data in patients with a BMI < 30. RESULTS: The median operative time was significantly longer (240 vs. 225 min, p = 0.021) and the mean blood loss was significantly higher (348 vs. 285 ml, p = 0.034) in the group of patients with BMI ≥ 30. No other significant differences, including conversion to open surgery and postoperative morbidity, were found between the two groups. CONCLUSION: Laparoscopic colorectal cancer surgery is feasible and safe in obese patients with a BMI above 30, without the patients experiencing an increased risk of postoperative morbidity or mortality.

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.

BACKGROUND: Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. METHODS: DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40). DISCUSSION: HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. TRIAL REGISTRATION: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

[Laparoscopic operation for colovesical fistula]. / Laparoskopisk operation for kolovesikal fistel.

Since 2005 the surgical department of Roskilde County Hospital has treated selected patients with colovesical fistulas laparoscopically. We describe two patients with symptoms of pneumaturia and urinary tract infections. CT scanning, cystoscopy and sigmoideoscopy showed colovesical fistula and laparoscopic operation was performed. The operating times were 280 and 285 minutes and the length of their hospital stays was four and three days without complications. We suggest that laparoscopic operation for colovesical fistula can be a good alternative to open operation on selected patients.

[Capsule endoscopy detection of metastasis of a malignant melanoma in the small intestine]. / Kapselendoskopisk påvisning af malignt melanom-metastase i tyndtarmen.

We report a case of a 74-year-old man with a Clark's level II, 2.5 mm melanoma on his back that was excised. A post-operative PET scan found no lesions. One and a half years later, the patient developed anaemia with blood in his stool. A gastroscopy and colonoscopy found no lesions. Video capsule endoscopy, however, detected a tumour in the small intestine. At laparotomy, the tumour was removed. Histological diagnosis showed metastatic malignant melanoma. We believe that video capsule endoscopy may increase the rate of diagnosis of small-bowel melanoma metastases.