Low radiographic muscle density is associated with lower overall and disease-free survival in early-stage colorectal cancer patients.

BACKGROUND: In cancer patients with a poor prognosis, low skeletal muscle radiographic density is associated with higher mortality. Whether this association also holds for early-stage cancer is not very clear. We aimed to study the association between skeletal muscle density and overall mortality among early-stage (stage I-III) colorectal cancer (CRC) patients. Furthermore, we investigated the association between skeletal muscle density and both CRC-specific mortality and disease-free survival in a subset of the study population. METHODS: Skeletal muscle density was assessed in 1681 early-stage CRC patients, diagnosed between 2006 and 2015, using pre-operative computed tomography images. Adjusted Cox proportional hazard models were used to evaluate the association between muscle density and overall mortality, CRC-specific mortality and disease-free survival. RESULTS: The median follow-up time was 48 months (range 0-119 months). Low muscle density was detected in 39% of CRC patients. Low muscle density was significantly associated with higher mortality (low vs. normal: adjusted HR 1.91, 95% CI 1.53-2.38). After stratification for comorbidities, the association was highest in patients with ≥ 2 comorbidities (HR 2.11, 95% CI 1.55-2.87). Furthermore, low skeletal muscle density was significantly associated with poorer disease-free survival (HR 1.68, 95% CI 1.14-2.47), but not with CRC-specific mortality (HR 1.68, 95% CI 0.89-3.17) in a subset of the study population. CONCLUSION: In early-stage CRC patients, low muscle density was significantly associated with higher overall mortality, and worse disease-free survival.

Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial.

PURPOSE: Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure in preventing a parastomal hernia, we performed a multicentre randomized controlled trial in 11 large teaching hospitals and three university centres in The Netherlands. METHODS: Augmentation of the abdominal wall with a retromuscular light-weight polypropylene mesh (Parietene Light™, Covidien) around the trephine was compared with traditional colostomy formation. Patients undergoing elective open formation of a permanent end-colostomy were eligible. 150 patients were randomized between 2010 and 2012. Primary endpoint of the PREVENT trial is the incidence of parastomal hernia. Secondary endpoints are morbidity, pain, quality of life, mortality and cost-effectiveness. This article focussed on the early results of the PREVENT trial and, therefore, operation time, postoperative morbidity, pain, and quality of life were measured. RESULTS: Outcomes represent results after 3 months of follow-up. A total of 150 patients were randomized. Mean operation time of the mesh group (N = 72) was significantly longer than in the control group (N = 78) (182.6 vs. 156.8 min; P = 0.018). Four (2.7 %) peristomal infections occurred of which one (1.4 %) in the mesh group. No infection of the mesh occurred. Most of the other infections were infections of the perineal wound, equally distributed over both groups. No statistical differences were discovered in stoma or mesh-related complications, fistula or stricture formation, pain, or quality of life. CONCLUSIONS: During open and elective formation of an end-colostomy, primary placement of a retromuscular light-weight polypropylene mesh for prevention of a parastomal hernia is a safe and feasible procedure. The PREVENT trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018 .

The laparoscopic modified Sugarbaker technique is safe and has a low recurrence rate: a multicenter cohort study.

BACKGROUND: Parastomal hernia is a frequent complication of intestinal stomata. Mesh repair gives the best results, with the mesh inserted via laparotomy or laparoscopically. It was the aim of this retrospective multicenter study to determine the early and late results of the laparoscopically performed, modified Sugarbaker technique with ePTFE mesh. METHODS: From 2005 to 2010, a total of 61 consecutive patients (mean age = 61 years), with a symptomatic parastomal hernia, underwent laparoscopic repair using the modified Sugarbaker technique with ePTFE mesh. Fifty-five patients had a colostomy, 4 patients an ileostomy, and 2 a urostomy according to Bricker. The records of the patients were reviewed with respect to patient characteristics, postoperative morbidity, and mortality. All patients underwent physical examination after a follow-up of at least 1 year to detect a recurrent hernia. Morbidity rate was 19 % and included wound infection (n = 1), ileus (n = 2), trocar site bleeding (n = 2), reintervention (n = 2), and pneumonia (n = 1). One patient died in the postoperative period due to metastasis of lung carcinoma that caused bowel obstruction. Concomitant incisional hernias were detected in 25 of 61 patients (41 %) and could be repaired at the same time in all cases. A recurrent hernia was found in three patients at physical examination, and in one patient an asymptomatic recurrence was found on a CT scan. The overall recurrence rate was 6.6 % after a mean follow-up of 26 months. CONCLUSION: The laparoscopic Sugarbaker technique is a safe procedure for repairing parastomal hernias. In our study, the overall morbidity was 19 % and the recurrence rate was 6.6 % after a mean follow-up of 26 months. Moreover, the laparoscopic approach revealed concomitant hernias in 41 % of the patients, which could be repaired successfully at the same time.

COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. TRIAL DESIGN: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

Laparoscopic parastomal hernia repair using a keyhole technique results in a high recurrence rate.

INTRODUCTION: Parastomal herniation is a common complication of stoma formation, and its operative treatment is notoriously difficult. Recently we have reported the promising short-term results of a keyhole technique in which a Gore-Tex Dual Mesh with a central keyhole is laparoscopically fashioned around the bowel to close the hernia. In the long-term, recurrence is one of the major issues in hernia repair, therefore, this aspect was prospectively investigated. METHODS: Since 2002, a total of 55 consecutive patients (27 men; median age, 63 years) with a symptomatic primary (n = 45) or recurrent parastomal hernia (n = 10) were electively operated using this technique. Patients were invited to the outpatient clinic on a regular basis and were examined for the occurrence of a recurrent hernia. At the last visit, all patients were asked to complete a short questionnaire. RESULTS: Median follow-up (98%) was 36 (range, 12-72) months. During follow-up a recurrent parastomal hernia was diagnosed in 20 patients (37%). Three recurrences were asymptomatic and were treated conservatively. The other 17 patients (85%) developed mild-to-severe symptoms necessitating redo-surgery in 9 (45%) patients. Surprisingly, satisfaction with the procedure was high among patients (89%), even in the presence of a recurrence. Patients who reported unsatisfactory results belonged mainly to the group in whom the initial laparoscopic approach had to be converted to an open procedure. CONCLUSIONS: Based on the results from the present study, which represents one of the largest patient series with the longest follow up available to date, it is concluded that laparoscopic parastomal hernia repair using a keyhole technique has an intolerably high recurrence rate with the currently available meshes. A new mesh with a less pliable central part and without the tendency to shrink is awaited.

[Donor nephrectomy: less fatigue and better quality of life following laparoscopic kidney removal compared with an open procedure by mini-incision: blind randomised study]. / Donornefrectomie: minder vermoeidheid en meer kwaliteit van leven na een laparoscopische uitname dan na een open ingreep met een mini-incisie: geblindeerd, gerandomiseerd onderzoek.

OBJECTIVE: Determining possible differences in living donor nephrectomy procedures: laparoscopy against mini-incision concerning discomfort to the donor and the maintenance of good graft function. DESIGN: Blind randomized study. METHOD: In two university medical centres, one hundred living kidney donors were randomly assigned to either total laparoscopic donor nephrectomy or mini-incision muscle-splitting open donor nephrectomy. Primary outcome was physical fatigue measured with the 'Multidimensional Fatigue Inventory' (MFI-20) during one-year follow-up. Secondary outcomes were physical function measured with the 'Short form-36' questionnaire, postoperative hospital stay, amount of pain, operating times and graft and patient survival. RESULTS: Donors who underwent laparoscopy experienced less fatigue (difference: -1.3; 95% CI: -2.4 - (-0.1)) and physical function was better (difference: 6.2; 95% CI: 2.0-10.3) during one-year follow-up. Those donors who underwent laparoscopy required less morphine (16 mg versus 25 mg; p = 0.005) and the duration of hospital stay was shorter (3 versus 4 days; p = 0.003). The laparoscopic procedure resulted in a longer operation time (221 versus 164 min; p < 0.001) a longer first warm ischaemia time (6 versus 3 min; p < 0.001) and less blood loss (100 versus 240 ml; p < 0.001). Recipient renal function and one-year graft survival rates did not differ. The number of preoperative and postoperative complications did not differ significantly between both surgery techniques. Conversions did not occur. CONCLUSION: Donor nephrectomy through laparoscopy led to less fatigue and a better quality of life compared with the open procedure. The safety factors for donors and recipients were comparable for both techniques. Laparoscopic donor nephrectomy is therefore the better surgical choice for kidney donor programmes with living donors.

Laparoscopic parastomal hernia repair is feasible and safe: early results of a prospective clinical study including 55 consecutive patients.

BACKGROUND: Parastomal herniation is a common complication, and its operative treatment is notoriously difficult. Recently, the authors have described a laparoscopic technique for closure and reinforcement of the hernia with a hand-made "funnel-shaped" Gore-Tex Dual Mesh. Potentially this technique combines the advantages of a mesh repair with those of minimal invasive surgery. METHODS: In 2002, a multicenter trial of this new technique was started in The Netherlands. To date, 55 consecutive patients (27 men; median age, 63 years) with a symptomatic primary (n = 45) or recurrent (n = 10) parastomal hernia have undergone elective surgery using this technique. The demographic, perioperative, and early follow-up data prospectively collected for these patients are presented in this report. RESULTS: Of the 55 procedures, 47 (85.5%) could be completed laparoscopically (median operation time, 120 min). Conversion to laparotomy was indicated because of dense adhesions prohibiting safe dissection (n = 4) or bowel injury (n = 4). No in-hospital mortality occurred. Postoperative recovery was uneventful for 47 patients (85%), who had a median hospital stay of 4 days. Surgical and nonsurgical complications occurred, respectively, for four patients each (7.2%). Full-thickness enterotomy appeared to be the most troublesome complication. After 6 weeks, when all the patients were reexamined, one recurrence was noted. CONCLUSION: Maximal efforts should be undertaken to prevent perioperative full-thickness enterotomy. Because this was achieved for the vast majority of patients, it is concluded that laparoscopic parastomal hernia repair is feasible and safe. Although a longer follow-up period is needed for definitive conclusions to be drawn regarding the recurrence rate, early follow-up evaluation shows very promising results.

Promising new technique in the repair of parastomal hernia.

Parastomal hernia is a common complication after stoma formation. Although not all hernias require surgical repair, a variety of surgical techniques exist. Fascial repair, relocation of the stoma, and the local use of a nonabsorbable mesh are the three major approaches. Despite this variety of techniques, recurrence rate and complications are high. We therefore invented a laparoscopic technique where we close the hernia and reinforce it with a hand-made "funnel-shaped" Gore-Tex dual mesh. This technique has all advantages of laparoscopy (less pain, short hospitalization) combined with the advantages of local mesh repair (no stoma replacement necessary, low recurrence rate). The risk of infection is also minimized. The shape of the Gore-Tex mesh reduces hernia recurrence even more, prevents prolapse, and allows easy colonoscopy and stoma irrigation.