LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection-a multicenter, open label, randomized controlled trial.

BACKGROUND: Due to faster recovery and lower morbidity rates, laparoscopy has become the gold standard in elective colorectal surgery for both the benign and malignant forms of the disease. A substantial proportion of colorectal operations are, however, carried out in emergency settings, and most of the emergency resections are still performed open. The aim of this study is to compare the laparoscopic versus open approach for emergency colorectal surgery. METHOD/DESIGN: This is a multicenter prospective randomized controlled trial including adult patients presenting with a condition requiring emergency colorectal resection. DISCUSSION: Previous studies cautiously recommend wider use of laparoscopy in emergency colorectal resections, but all earlier reports are retrospective, are mostly single-center studies, and have limited numbers of patients. Laparoscopy may involve some unpredictable risks that have not yet been reported because of the infrequent use of the techniqueded to assess the safety of laparoscopy as well as the advantages and disadvantages of open compared with laparoscopic emergency surgery. TRIAL REGISTRATION: Trial registration number:  ClinicalTrials.gov   NCT05005117 . Registered on August 12, 2021.

Obstructive Sleep Apnea: The Effect of Bariatric Surgery After Five Years-A Prospective Multicenter Trial.

BACKGROUND: The prevalence of obstructive sleep apnea (OSA) is high among the bariatric surgery candidates. Obesity is the most important individual risk factor for OSA. The aim of this study was to investigate the effect of a laparoscopic Roux-en-Y gastric bypass (LRYGB) on OSA 5 years after the surgery. PATIENTS AND METHODS: In this prospective multicenter study, standard overnight cardiorespiratory recording was conducted to 150 patients at baseline prior to bariatric surgery. A total of 111 (73.3%) patients of those had OSA. Cardiorespiratory recordings at 5 years after surgery were available for 70 OSA patients. The changes in anthropometric and demographic measurements including age, weight, body mass index (BMI), and waist and neck circumference were evaluated. Also, a quality of life (QoL) questionnaire 15D administered in a baseline was controlled at 5-year follow-up visit. RESULTS: At 5-year OSA was cured in 55% of patients, but moderate or severe OSA still persisted in 20% of patients after operation. Mean total AHI decreased from 27.8 events/h to 8.8 events/h (p < 0.001) at 5-year follow-up. A clinically significant difference in QoL was seen in mobility, breathing, sleeping, usual activities, discomfort and symptoms, vitality and sexual activity. The QoL total score improved more in OSA patient at 5-year follow-up. CONCLUSIONS: LRYGB is an effective treatment of OSA in obese patients and the achieved beneficial outcomes are maintained at 5-year follow-up.

Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial).

BACKGROUND: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. METHODS: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. RESULTS: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. CONCLUSION: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. REGISTRATION NUMBER: NCT03445936 (http://www.clinicaltrials.gov).

One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

PURPOSE: The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair. METHODS: This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18-85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Progrip™ mesh in open inguinal hernia surgery. The primary outcome was the number of additional follow-up visits due to post-operative pain. Secondary outcomes included intensity of pain, quality of life measures, and complications. RESULTS: Two hundred seventy patients were included in this trial, 132 with Adhesix™ (A group), and 138 with Progrip™ (P-group). All patients' medical records were reviewed 12 months after surgery, and 207 patients (76.2%) completed 12-month follow-up. The number of patients needing additional follow-up visits 3-12 months after surgery were comparable (A group 3/3.0%, P-group 6/5.6%). The numeric rating scale was low at 12 months after surgery (at rest A 0.21, P 0.34, at exercise A 0.78, P 0.90). The incidence of chronic pain, that is moderate or severe pain during exercise, was 5 patients (5.2%) with Adhesix™ and 8 patients (7.4%) with Progrip™ (P = 0.333). Two hernia recurrences (1.0%) were established, one in each group. CONCLUSION: At 1 year after hernia surgery, the use of self-gripping and self-adhesive meshes lead to successful pain reduction and quality of life improvement. CLINICALTRIALS: com NCT03734224.

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial.

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.

Evaluation of a wrist-worn photoplethysmography monitor for heart rate variability estimation in patients recovering from laparoscopic colon resection.

To evaluate the accuracy of heart rate variability (HRV) parameters obtained with a wrist-worn photoplethysmography (PPG) monitor in patients recovering from minimally invasive colon resection to investigate whether PPG has potential in postoperative patient monitoring. 31 patients were monitored for three days or until discharge or reoperation using a wrist-worn PPG monitor (PulseOn, Finland) with a Holter monitor (Faros 360, Bittium Biosignals, Finland) as a reference measurement device. Beat-to-beat intervals (BBI) and HRV information collected by PPG were compared with RR intervals (RRI) and HRV obtained from the ECG reference after removing artefacts and ectopic beats. The beat-to-beat mean error (ME) and mean absolute error (MAE) of good quality heartbeat intervals obtained by wrist PPG were estimated as - 1.34 ms and 10.4 ms respectively. A significant variation in the accuracy of the HRV parameters was found. In the time domain, SDNN (9.11%), TRI (11.4%) and TINN (11.1%) were estimated with low relative MAE, while RMSSD (34.3%), pNN50 (139%) and NN50 (188%) had higher errors. The logarithmic parameters in the frequency domain (VLF Log, LF Log and HF Log) exhibited the lowest relative error, and for non-linear parameters, SD2 (7.5%), DFA α1 (8.25%) and DFA α2 (4.71%) were calculated much more accurately than SD1 (34.3%). The wrist PPG shows some potential for use in a clinical setting. The accuracy of several HRV parameters analyzed post hoc was found sufficient to be used in further studies concerning postoperative recovery of patients undergoing laparoscopic colon resection, although there were large errors in many common HRV parameters such as RMSSD, pNN50 and NN50, rendering them unusable.ClinicalTrials.gov Identifier: NCT04996511, August 9, 2021, retrospectively registered.

Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial.

Importance: Severe obesity is a major health concern. However, a few patients remain resistant to bariatric surgery and other treatments. Animal studies suggest that weight may be altered by fecal microbiota transplantation (FMT) from a lean donor. Objective: To determine whether FMT from a lean donor reduces body weight and further improves the results of bariatric surgery. Design, Setting, and Participants: This double-blinded, placebo-controlled, multicenter, randomized clinical trial was conducted in 2018 to 2021 among adult individuals with severe obesity treated at 2 bariatric surgery centers in Finland and included 18 months of follow-up. Patients eligible for bariatric surgery were recruited for the study. Data were analyzed from March 2021 to May 2022. Interventions: FMT from a lean donor or from the patient (autologous placebo) was administered by gastroscopy into the duodenum. Bariatric surgery was performed 6 months after the baseline intervention using laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG). Main Outcomes and Measures: The main outcome was weight reduction measured as the percentage of total weight loss (TWL). Results: Forty-one patients were recruited to participate in the study and were included in the final analysis (29 women [71.1%]; mean [SD] age, 48.7 [8.7] years; mean [SD] body mass index, 42.5 [6.0]). A total of 21 patients received FMT from a lean donor, and 20 received an autologous placebo. Six months after FMT, 34 patients underwent LRYGB and 4 underwent LSG. Thirty-four patients (82.9%) attended the last visit 18 months after the baseline visit. The percentage of TWL at 6 months was 4.8% (95% CI, 2.7% to 7.0%; P < .001) in the FMT group and 4.6% (95% CI, 1.5% to 7.6%; P = .006) in the placebo group, but no difference was observed between the groups. At 18 months from the baseline (ie, 12 months after surgery), the percentage of TWL was 25.3% (95% CI, 19.5 to 31.1; P < .001) in the FMT group and 25.2% (95% CI, 20.2 to 30.3; P < .001) in the placebo group; however, no difference was observed between the groups. Conclusions and Relevance: FMT did not affect presurgical and postsurgical weight loss. Further studies are needed to elucidate the possible role of FMT in obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT03391817.

One-year functional outcomes of patients aged 80 years or more undergoing colonic cancer surgery: prospective, multicentre observational study.

BACKGROUND: Older patients are at high risk of experiencing delayed functional recovery after surgical treatment. This study aimed to identify factors that predict changes in the level of support for activities of daily living and mobility 1 year after colonic cancer surgery. METHODS: This was a multicentre, observational study conforming to STROBE guidelines. The prospective data included pre-and postoperative mobility and need for support in daily activities, co-morbidities, onco-geriatric screening tool (G8), clinical frailty scale (CFS), operative data, and postoperative surgical outcomes. RESULTS: A total of 167 patients aged 80 years or more with colonic cancer were recruited. After surgery, 30 per cent and 22 per cent of all patients had increased need for support and decreased motility. Multivariableanalysis with all patients demonstrated that preoperative support in daily activities outside the home (OR 3.23, 95 per cent c.i. 1.06 to 9.80, P = 0.039) was associated with an increased support at follow-up. A history of cognitive impairment (3.15, 1.06 to 9.34, P = 0.038) haemoglobin less than 120 g/l (7.48, 1.97 to 28.4, P = 0.003) and discharge to other medical facilities (4.72, 1.39 to 16.0, P = 0.013) were independently associated with declined mobility. With functionally independent patients, haemoglobin less than 120 g/l (8.31, 1.76 to 39.2, P = 0.008) and discharge to other medical facilities (4.38, 1.20 to 16.0, P = 0.026) were associated with declined mobility. CONCLUSION: Increased need for support before surgery, cognitive impairment, preoperative anaemia, and discharge to other medical facilities predicts an increased need for support or declined mobility 1 year after colonic cancer surgery. Preoperative assessment and optimization should focus on anaemia correction, nutritional status, and mobility with detailed rehabilitation plan.

A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia.

BACKGROUND: This was a prospective, multicentre, non-blinded, randomized clinical trial involving two parallel groups of patients. METHODS: Adult patients with symptomatic unilateral primary inguinal hernia were included in this study. Patients were enrolled and treated in five Finnish hospitals. Eligible patients were randomized by use of a computer-based program to receiving either open anterior repair (modified Lichtenstein) with glue mesh fixation or totally extraperitoneal (TEP) repair. The primary aims were to compare 30-day patient-reported pain scores and return to work after surgery between the two groups. RESULTS: A total of 202 patients were randomized: 98 patients to TEP repair and 104 patients to open repair. All randomized patients received their allocated treatment. A total of 86 patients (88 per cent) in the TEP group and 94 patients (90 per cent) in the Lichtenstein group completed the 30-day follow-up. Patients experienced less early pain (P < 0.001) and used less analgesics after TEP repair, compared to those who had modified Lichtenstein repair. Two patients in the TEP group and five in the Lichtenstein group developed superficial wound infection (P = 0⋅446). Only one reoperation was performed in the Lichtenstein group due to haematoma. CONCLUSION: TEP inguinal hernia repair is associated with less early postoperative pain compared to the open glue mesh fixation technique. TRIAL REGISTRATION: NCT03566433 (http://www.clinicaltrials.gov).

In this randomized clinical trial, we compared two different operating techniques for inguinal hernia repair. Patients were randomized to receiving either open or laparoscopic inguinal hernia repair. After the operation, patient-reported pain and functional outcomes were compared. Patients experienced less pain after laparoscopic repair.

Surgical and functional outcomes and survival following Colon Cancer surgery in the aged: a study protocol for a prospective, observational multicentre study.

BACKGROUND: The number of colorectal cancer patients increases with age. The decision to go through major surgery can be challenging for the aged patient and the surgeon because of the heterogeneity within the older population. Differences in preoperative physical and cognitive status can affect postoperative outcomes and functional recovery, and impact on patients' quality of life. METHODS / DESIGN: A prospective, observational, multicentre study including nine hospitals to analyse the impact of colon cancer surgery on functional ability, short-term outcomes (complications and mortality), and their predictors in patients aged ≥80 years. The catchment area of the study hospitals is 3.88 million people, representing 70% of the population of Finland. The data will be gathered from patient baseline characteristics, surgical interventional data, and pre- and postoperative patient-questionnaires, to an electronic database (REDCap) especially dedicated to the study. DISCUSSION: This multicentre study provides information about colon cancer surgery's operative and functional outcomes on older patients. A further aim is to find prognostic factors which could help to predict adverse outcomes of surgery. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03904121 ). Registered on 1 April 2019.

Keyhole versus Sugarbaker techniques in parastomal hernia repair following ileal conduit urinary diversion: a retrospective nationwide cohort study.

BACKGROUND: Previous research on parastomal hernia repair following ileal conduit urinary diversion is limited. This nationwide cohort study aims to present the results of keyhole and Sugarbaker techniques in parastomal hernia repair in the setting of ileal conduit urinary diversion. METHOD: All patients in this cohort underwent primary elective parastomal hernia repair following ileal conduit urinary diversion in four university hospitals and one central hospital in Finland in 2007-2017. Retrospective clinical data were collected from patient registries to compare keyhole and Sugarbaker parastomal hernia repair techniques. The primary outcome was parastomal hernia recurrence during the follow-up from primary surgery to the last confirmed follow-up date of the patient. The secondary outcomes were reoperations during the follow-up and complication rate at 30 days' follow-up. RESULTS: The results of 28 hernioplasties were evaluated. The overall parastomal hernia recurrence rate was 18%, the re-operation rate was 14%, and the complication rate was 14% during the median follow-up time of 30 (21-64) months. Recurrence rates were 22% (4/18) after keyhole repair and 10% (1/10) after Sugarbaker repair. Re-operation rates referred to keyhole repair were 22% and Sugarbaker repair 0% during follow-up. The majority of reoperations were indicated by recurrence. Complication rates were 17% after keyhole and 10% after Sugarbaker repair during the 30 days' follow-up. CONCLUSION: The results of parastomal hernia repair in the setting of ileal conduits are below optimal in this nationwide cohort comparing keyhole to Sugarbaker repair in elective parastomal hernia repair. Nonetheless, the Sugarbaker technique should be further studied to confirm the encouraging results of this cohort in terms of recurrence.

The Clinical Frailty Scale is a useful tool for predicting postoperative complications following elective colon cancer surgery at the age of 80 years and above: A prospective, multicentre observational study.

AIM: Identification of the risks of postoperative complications may be challenging in older patients with heterogeneous physical and cognitive status. The aim of this multicentre, observational study was to identify variables that affect the outcomes of colon cancer surgery and, especially, to find tools to quantify the risks related to surgery. METHOD: Patients aged ≥80 years with electively operated Stage I-III colon cancer were recruited. The prospectively collected data included comorbidities, results of the onco-geriatric screening tool (G8), Clinical Frailty Scale (CFS), Charlson Comorbidity Index (CCI) and Mini Nutritional Assessment-Short Form (MNA-SF), and operative and postoperative outcomes. RESULTS: A total of 161 patients (mean 84.5 years, range 80-97, 60% female) were included. History of cerebral stroke (64% vs. 37%, p = 0.02), albumin level 31-34 g/l compared with ≥35 g/l (57% vs. 32%, p = 0.007), CFS 3-4 and 5-9 compared with CFS 1-2 (49% and 47% vs. 16%, respectively) and American Society of Anesthesiologists score >3 (77% vs. 28%, P = 0.006) were related to a higher risk of complications. In multivariate logistic regression analysis CFS ≥3 (OR 6.06, 95% CI 1.88-19.5, p = 0.003) and albumin level 31-34 g/l (OR 3.88, 1.61-9.38, p = 0.003) were significantly associated with postoperative complications. Severe complications were more common in patients with chronic obstructive pulmonary disease (43% vs. 13%, p = 0.047), renal failure (25% vs. 12%, p = 0.021), albumin level 31-34 g/l (26% vs. 8%, p = 0.014) and CCI >6 (23% vs. 10%, p = 0.034). CONCLUSION: Surgery on physically and cognitively fit aged colon cancer patients with CFS 1-2 can lead to excellent operative outcomes similar to those of younger patients. The CFS could be a useful screening tool for predicting postoperative complications.

Parastomal Hernia: A Retrospective Nationwide Cohort Study Comparing Different Techniques with Long-Term Follow-Up.

BACKGROUND: Parastomal hernia repair is a complex surgical procedure with high recurrence and complication rates. This retrospective nationwide cohort study presents the results of different parastomal hernia repair techniques in Finland. METHODS: All patients who underwent a primary end ostomy parastomal hernia repair in the nine participating hospitals during 2007-2017 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. RESULTS: In total, 235 primary elective parastomal hernia repairs were performed in five university hospitals and four central hospitals in Finland during 2007-2017. The major techniques used were the Sugarbaker (38.8%), keyhole (16.3%), and sandwich techniques (15.4%). In addition, a specific intra-abdominal keyhole technique with a funnel-shaped mesh was utilized in 8.3% of the techniques; other parastomal hernia repair techniques were used in 21.3% of the cases. The median follow-up time was 39.0 months (0-146, SD 35.3). The recurrence rates after the keyhole, Sugarbaker, sandwich, specific funnel-shaped mesh, and other techniques were 35.9%, 21.5%, 13.5%, 15%, and 35.3%, respectively. The overall re-operation rate was 20.4%, while complications occurred in 26.3% of patients. CONCLUSION: The recurrence rate after parastomal hernia repair is unacceptable in this nationwide cohort study. As PSH repair volumes are low, further multinational, randomized controlled trials and hernia registry data are needed to improve the results.

Laparoscopic Colectomy vs Laparoscopic CME: a Retrospective Study of Two Hospitals with Comparable Laparoscopic Experience.

PURPOSE: To compare laparoscopic non-CME colectomy with laparoscopic CME colectomy in two hospitals with similar experience in laparoscopic colorectal surgery. METHODS: Data was collected retrospectively from Päijät-Häme Central Hospital (PHCH, NCME group) and Central Finland Central Hospital (CFCH, CME group) records. Elective laparoscopic resections performed during 2007-2016 for UICC stage I-III adenocarcinoma were included to assess differences in short-term outcome and survival. RESULTS: There were 340 patients in the NCME group and 325 patients in the CME group. CME delivered longer specimens (p < 0.001), wider resection margins (p < 0.001), and more lymph nodes (p < 0.001) but did not result in better 5-year overall or cancer-specific survival (NCME 77.9% vs CME 72.9%, p = 0.528, NCME 93.2% vs CME 88.9%, p = 0.132, respectively). Thirty-day morbidity, mortality, and length of hospital stay were similar between the groups. Conversion to open surgery was associated with decreased survival. DISCUSSION: Complete mesocolic excision (CME) is reported to improve survival. Most previous studies have compared open CME with open non-CME (NCME) or open CME with laparoscopic CME. NCME populations have been historical or heterogeneous, potentially causing bias in the interpretation of results. Studies comparing laparoscopic CME with laparoscopic NCME are few and involve only small numbers of patients. In this study, diligently performed laparoscopic non-CME D2 resection delivered disease-free survival results comparable with laparoscopic CME but was not safer.

Prospective, Randomized Study on the Use of Prosthetic Mesh to Prevent a Parastomal Hernia in a Permanent Colostomy: Results of a Long-term Follow-up.

BACKGROUND: Parastomal hernias are common with permanent colostomies and prone to complications. The short-term results of trials of parastomal hernia prevention are widely published, but long-term results are scarce. OBJECTIVE: The aim of the study is to detect the long-term effects and safety of preventive intra-abdominal parastomal mesh. DESIGN: This is a long-term follow-up of a previous prospective randomized, controlled multicenter trial. SETTINGS: This study was conducted at 2 university hospitals and 3 central hospitals in Finland. PATIENTS: Patients who had a laparoscopic abdominoperineal resection for rectal cancer between 2010 and 2013 were included in the study and invited for a follow-up visit. MAIN OUTCOME MEASURES: The primary outcomes measured were clinical and radiological parastomal hernias. RESULTS: Twenty subjects in the mesh group and 15 in the control group attended the follow-up visit with a median follow-up period of 65 (25th-75th percentiles, 49-91) months. A clinically detectable parastomal hernia was present in 4 of 20 (20.0%) and 5 of 15 (33.3%) subjects in the mesh and control groups (p = 0.45). A radiological parastomal hernia was present in 9 of 19 (45.0%) subjects in the mesh group and 7 of 12 (58.3%) subjects in the control group (p = 0.72). However, when all subjects (n = 70, 1:1) who attended the 12-month follow-up were screened for long-term results according to register data, 9 of 35 (25.9%) subjects in the mesh group and 16 of 35 (45.6%) subjects in control group were diagnosed with a parastomal hernia during the follow-up period (p = 0.10). In addition, only 1 of 35 (2.7%) subjects in the mesh group but 6 of 35 (17.1%) subjects in the control group underwent a parastomal hernia operation during the long-term follow-up (p = 0.030). LIMITATIONS: The study is limited by the small number of patients. CONCLUSION: Prophylactic intra-abdominal keyhole mesh did not decrease the rate of clinically detectable hernias but reduced the need for the surgical repair of parastomal hernias. Further trials are needed to identify a more efficient method to prevent parastomal hernias. See Video Abstract at http://links.lww.com/DCR/B171. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov. Identifier: NCT02368873. ESTUDIO PROSPECTIVO ALEATORIZADO SOBRE EL USO DE MALLA PROTÉSICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMÍA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCIÓN DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomías permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevención de la hernia parastomal se publican ampliamente, pero los resultados a largo plazo son escasos.El objetivo del estudio es detectar los efectos a largo plazo y la seguridad de la malla parastomal intraabdominal preventiva.Este es un seguimiento a largo plazo de un estudio aleatorizado prospectivo, controlado y multicentrico previo.Este estudio se realizó en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una resección abdominoperineal laparoscópica por cáncer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clínicas y radiológicas.Veinte sujetos en el grupo de malla y 15 en el grupo control asistieron a la visita de seguimiento con una mediana de seguimiento de 65 meses (25-75 ° percentil 49-91). Una hernia paraestomal clínicamente detectable estuvo presente en 4/20 (20.0%) y 5/15 (33.3%) en los grupos de malla y control, respectivamente (p = 0.45). Una hernia parastomal radiológica estuvo presente en 9/19 (45.0%) en el grupo de malla y 7/12 (58.3%) en el grupo de control (p = 0.72). Sin embargo, cuando todos los sujetos (n = 70, 1: 1) que asistieron a los 12 meses de seguimiento fueron evaluados para obtener resultados a largo plazo de acuerdo con los datos del registro, 9/35 (25.9%) sujetos en el grupo de malla y 16/35 (45,6%) sujetos en el grupo control fueron diagnosticados con una hernia paraestomal durante el período de seguimiento (p = 0,10). Además, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operación de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio está limitado por un pequeño número de pacientes.La malla intra-abdominal profiláctica en ojo de cerradura no disminuyó la tasa de hernias clínicamente detectables, pero redujo la necesidad de la reparación quirúrgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un método más eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traducción-Dr. Gonzalo Hagerman).NCT02368873.

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results.

PURPOSE: Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR. METHODS: This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured. RESULTS: At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014). CONCLUSION: Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL. TRIAL REGISTRY: Clinical trial number NCT02542085.

Risk factors of short-term survival in the aged in elective colon cancer surgery: a population-based study.

PURPOSE: Patients aged > 80 years represent an increasing proportion of colon cancer diagnoses. Selecting patients for elective surgery is challenging because of possibly compromised health status and functional decline. The aim of this retrospective, population-based study was to identify risk factors and health measures that predict short-term mortality after elective colon cancer surgery in the aged. METHODS: All patients > 80 years operated electively for stages I-III colon cancer from 2005 to 2016 in four Finnish hospitals were included. The prospectively collected data included comorbidities, functional status, postoperative surgical and medical outcomes as well as mortality data. RESULTS: A total of 386 patients (mean 84.0 years, range 80-96, 56% female) were included. Male gender (46% vs 35%, p = 0.03), higher BMI (51% vs 37%, p = 0.02), diabetes mellitus (51% vs 37%, p = 0.02), coronary artery disease (52% vs 36%, p = 0.003) and rheumatic diseases (67% vs 39%, p = 0.03) were related to higher risk of complications. The severe complications were more common in patients with increased preoperative hospitalizations (31% vs 15%, p = 0.05) and who lived in nursing homes (30% vs 17%, p = 0.05). The 30-day and 1-year mortality rates were 6.0% and 15% for all the patients compared with 30% and 45% in patients with severe postoperative complications (p < 0.001). Severe postoperative complications were the only significant patient-related variable affecting 1-year mortality (OR 9.60, 95% CI 2.33-39.55, p = 0.002). CONCLUSIONS: The ability to identify preoperatively patients at high risk of decreased survival and thus prevent severe postoperative complications could improve overall outcome of aged colon cancer patients.

Chimney Trial: study protocol for a randomized controlled trial.

BACKGROUND: Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs. METHODS/DESIGN: The Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh®-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh. The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. DISCUSSION: The Chimney Trial aims to provide level-I evidence on PSH prevention. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03799939. Registered on 10 January 2019.

Preloop trial: study protocol for a randomized controlled trial.

BACKGROUND: A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist. METHOD/DESIGN: The Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro™, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol™, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure. The main endpoints in this trial are infections at 30-day follow-up and the incidence of hernias clinically or on CT scan at 10 months after closure of the stoma. The secondary endpoints are other complications within 30 days of surgery graded with the Clavien-Dindo classification, reoperation rate, operating time, length of stay, quality of life measured with RAND-36, and incidence of hernia over a 5-year follow-up period. A total of 100 patients will be randomized in a 1:1 ratio. DISCUSSION: This is a pilot trial that will be undertaken to provide some novel evidence on the safety profile and efficiency of both synthetic mesh and biological implants for the prevention of incisional hernias after closure by temporary loop ileostomy. The hypothesis is that synthetic mesh is economical but equally safe and at least as effective as biological implants in hernia prevention and in contaminated surgical sites. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03445936 . Registered on 7 February 2018.

Does Ventral Rectopexy Improve Pelvic Floor Function in the Long Term?

BACKGROUND: Information is needed on long-term functional results, sequelas, and outcome predictors for laparoscopic ventral mesh rectopexy. OBJECTIVE: The purpose of this study was to evaluate long-term function postventral rectopexy in patients with external rectal prolapse or internal rectal prolapse in a large cohort and to identify the possible effects of patient-related factors and operative technical details on patient-reported outcomes. DESIGN: This was a retrospective review with a cross-sectional questionnaire study. SETTINGS: Data were collated from prospectively collected registries in 2 university and 2 central hospitals in Finland. PATIENTS: All 508 consecutive patients treated with ventral rectopexy for external rectal prolapse or symptomatic internal rectal prolapse in 2005 to 2013 were included. INTERVENTIONS: A questionnaire concerning disease-related symptoms and effect on quality of life was used. MAIN OUTCOME MEASURES: Defecatory function measured by the Wexner score, the obstructive defecation score, and subjective symptom and quality-of-life evaluation using the visual analog scale were included. The effects of patient-related factors and operative technical details were assessed using multivariate analysis. RESULTS: The questionnaire response rate was 70.7% (330/467 living patients) with a median follow-up time of 44 months. The mean Wexner scores were 7.0 (SD = 6.1) and 6.9 (SD = 5.6), and the mean obstructive defecation scores were 9.7 (SD = 7.6) and 12.3 (SD = 8.0) for patients presenting with external rectal prolapse and internal rectal prolapse. Subjective symptom relief was experienced by 76% and reported more often by patients with external rectal prolapse than with internal rectal prolapse (86% vs 68%; p < 0.001). Complications occurred in 11.4% of patients, and the recurrence rate for rectal prolapse was 7.1%. LIMITATIONS: This study was limited by its lack of preoperative functional data and suboptimal questionnaire response rate. CONCLUSIONS: Ventral mesh rectopexy effectively treats posterior pelvic floor dysfunction with a low complication rate and an acceptable recurrence rate. Patients with external rectal prolapse benefit more from the operation than those with symptomatic internal rectal prolapse. See Video Abstract at http://links.lww.com/DCR/A479.