Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial.

Importance: Surgical site infections (SSIs)-especially anastomotic dehiscence-are major contributors to morbidity and mortality after rectal resection. The role of mechanical and oral antibiotics bowel preparation (MOABP) in preventing complications of rectal resection is currently disputed. Objective: To assess whether MOABP reduces overall complications and SSIs after elective rectal resection compared with mechanical bowel preparation (MBP) plus placebo. Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 3 university hospitals in Finland between March 18, 2020, and October 10, 2022. Patients aged 18 years and older undergoing elective resection with primary anastomosis of a rectal tumor 15 cm or less from the anal verge on magnetic resonance imaging were eligible for inclusion. Outcomes were analyzed using a modified intention-to-treat principle, which included all patients who were randomly allocated to and underwent elective rectal resection with an anastomosis. Interventions: Patients were stratified according to tumor distance from the anal verge and neoadjuvant treatment given and randomized in a 1:1 ratio to receive MOABP with an oral regimen of neomycin and metronidazole (n = 277) or MBP plus matching placebo tablets (n = 288). All study medications were taken the day before surgery, and all patients received intravenous antibiotics approximately 30 minutes before surgery. Main Outcomes and Measures: The primary outcome was overall cumulative postoperative complications measured using the Comprehensive Complication Index. Key secondary outcomes were SSI and anastomotic dehiscence within 30 days after surgery. Results: In all, 565 patients were included in the analysis, with 288 in the MBP plus placebo group (median [IQR] age, 69 [62-74] years; 190 males [66.0%]) and 277 in the MOABP group (median [IQR] age, 70 [62-75] years; 158 males [57.0%]). Patients in the MOABP group experienced fewer overall postoperative complications (median [IQR] Comprehensive Complication Index, 0 [0-8.66] vs 8.66 [0-20.92]; Wilcoxon effect size, 0.146; P < .001), fewer SSIs (23 patients [8.3%] vs 48 patients [16.7%]; odds ratio, 0.45 [95% CI, 0.27-0.77]), and fewer anastomotic dehiscences (16 patients [5.8%] vs 39 patients [13.5%]; odds ratio, 0.39 [95% CI, 0.21-0.72]) compared with patients in the MBP plus placebo group. Conclusions and Relevance: Findings of this randomized clinical trial indicate that MOABP reduced overall postoperative complications as well as rates of SSIs and anastomotic dehiscences in patients undergoing elective rectal resection compared with MBP plus placebo. Based on these findings, MOABP should be considered as standard treatment in patients undergoing elective rectal resection. Trial Registration: ClinicalTrials.gov Identifier: NCT04281667.

Sacral neuromodulation in endometriosis - A promising treatment option for chronic pelvic pain.

INTRODUCTION: Chronic pelvic pain (CPP) affects over one fifth of women worldwide, and endometriosis is one of the most common causes. In the present study, we examined whether sacral neuromodulation (SNM) is effective in the treatment of refractory chronic pelvic pain in women with endometriosis. MATERIAL AND METHODS: This multicenter prospective pilot study was started in 2017 and includes patients with chronic pelvic pain with no other obvious pathology than endometriosis. Other treatment options have been tried or they are unsuitable. Patients underwent SNM implantation. The main outcome was postoperative pain reduction and secondary outcome was quality of life. The following questionnaires were used to assess the outcomes: Brief pain inventory (BPI), clinical global impression - improvement (CGI-I), 15D-measure of health-related quality of life, and Biberoglu and Behrman (B&B) score. RESULTS: A total of 35 patients underwent the SNM procedure and, at the time of analysis, 15 patients had returned one-year questionnaires. The patients had a history of endometriosis for a median of 5.5 (interquartile range 2-9) years, with no correlation between the severity of symptoms and the duration of the disease (p = 0.158). A total of 31 patients (89%) were implanted with the internal pulse generator. There were statistically significant changes in BPI pain-related items. Worst experienced daily pain decreased among those who returned 12-month questionnaires from median 9 to 5 (p = 0.006), average daily pain from 6 to 3.5 (p = 0.004), and least daily pain from 3 to 1 (p = 0.004). Based on the CGI questionnaire (n = 14), at 12 months nine patients (60%) experienced great improvement in their symptoms, three patients (20%) much improvement and two patients (13%) minimal improvement. None of the patients experienced worsening of their symptoms. There was a statistically significant change in overall 15D score at 1 month (p < 0.001), 6 months (p = 0.001) and 12 months (p = 0.018), when the results were compared to baseline values. Median B&B score also improved significantly and decreased from a baseline value of 8 (4-12) to 4.5 (0-6), p = 0.002. CONCLUSIONS: Based on the preliminary findings of our study, SNM might be a promising treatment of CPP in endometriosis patients.

Mobile-CEA - A Novel Surveillance Method for Patients with Colorectal Cancer.

OBJECTIVE: The follow-up of the increasing number of cancer survivors threatens to overload the health care system. While short message system (SMS)-based communication is widely used in other areas of the health care system, there are no studies of its appliance in cancer surveillance. The aim of the current study was to analyze the acceptability, convenience and impact of a novel mobile phone messaging -based system (Mobile-CEA) on health personnel contacts in patients with colorectal cancer (CRC) during 2 years of follow-up. METHODS: The follow-up data of 52 curatively treated patients with CRC (22 Mobile-CEA-, 30 standard surveillance) was collected retrospectively from the electronic archives. Mobile-CEA patient satisfaction was measured by a tailored non-validated questionnaire. Health personnel satisfaction was assessed by personal interviews. RESULTS: Mobile-CEA surveillance group had less health personnel contacts than the standard surveillance group: median 3 (min 0-max 7) vs 5 (min 4-max 7) and 77.2% of the Mobile-CEA group had less than 4 contacts (minimum with the standard surveillance) to health personnel. There were no recurrences in either group. Mobile-CEA patients were satisfied with this novel follow-up method. Health personnel considered it as a practical and safe tool in CRC surveillance. CONCLUSION: Mobile-CEA surveillance seems to be a promising and effective follow-up method for curatively treated patients with CRC. Further studies and experiences are needed.

Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial-study protocol.

INTRODUCTION: Mechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery. METHODS AND ANALYSIS: The MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed. ETHICS AND DISSEMINATION: The Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals. TRIAL REGISTRATION NUMBER: NCT04281667.

Validation of the low anterior resection syndrome score in finnish patients: preliminary results on quality of life in different lars severity groups.

BACKGROUND AND AIMS: Low anterior resection syndrome is common after anterior resection for rectal cancer. Its severity can be tested with the low anterior resection syndrome score. We have translated the low anterior resection syndrome score to Finnish, and the aim of this study is to validate the translation. MATERIALS AND METHODS: The translated Finnish low anterior resection syndrome score and European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-C30 and QLQ-CR29 questionnaires were sent to 159 surviving patients operated with anterior resection for rectal adenocarcinoma between 2007 and 2014 in a tertiary referral center. Psychometric properties of the translation were evaluated in comparison to quality-of-life scales and in different risk factor groups. RESULTS: In the study, 104 (65%) patients returned the questionnaires. Of these, 56 (54%) had major low anterior resection syndrome, 26 (25%) had minor low anterior resection syndrome, and 22 (21%) had no low anterior resection syndrome. Patients with major low anterior resection syndrome had a significantly lower quality of life and more defecatory symptoms as assessed with the European Organisation for Research and Treatment of Cancer questionnaires compared with those with no low anterior resection syndrome. Patients operated with total mesorectal excision had significantly higher low anterior resection syndrome scores compared with those operated with partial mesorectal excision (median/interquartile range 32/15 and 29/11, respectively, p = 0.037). The test-retest validity of the translation was good with an intraclass correlation coefficient of 0.77 (95% confidence interval 0.51-0.90). CONCLUSIONS: The Finnish low anterior resection syndrome score is a valid test in the assessment of postoperative bowel function and its impact on the quality of life. It can be implemented to use during regular follow-up visits of Finnish-speaking rectal cancer patients.

Impact of sphincter lesions and delayed sphincter repair on sacral neuromodulation treatment outcomes for faecal incontinence: results from a Finnish national cohort study.

PURPOSE: The aim of this multicentre study was to analyse the effects of patent sphincter lesions and previous sphincter repair on the results of sacral neuromodulation (SNM) treatment on patients with faecal incontinence (FI). METHODS: Patients examined by endoanal ultrasound (EAUS) with FI as the indication for SNM treatment were included in the study. Data was collected from all the centres providing SNM treatment in Finland and analysed for differences in treatment outcomes. RESULTS: A total of 237 patients treated for incontinence with SNM had been examined by EAUS. Of these patients, 33 had a history of previous delayed sphincter repair. A patent sphincter lesion was detected by EAUS in 128 patients. The EAUS finding did not influence the SNM test phase outcome (p = 0.129) or the final treatment outcome (p = 0.233). Patient's history of prior sphincter repair did not have a significant effect on the SNM test (p = 0.425) or final treatment outcome (p = 0.442). CONCLUSIONS: Results of our study indicate that a sphincter lesion or previous sphincter repair has no significant effect on the outcome of SNM treatment. Our data suggests that delayed sphincter repair prior to SNM treatment initiation for FI is not necessary.

Sacral Neuromodulation: Foray into Chronic Pelvic Pain in End Stage Endometriosis.

Excision of all endometriotic lesions is the method of choice in the treatment of severe endometriosis resistant to medical therapy. The infiltrating nature of the disease as well as extensive surgery may, however, cause chronic pain that cannot be relieved by either surgery or hormonal treatment. As a pilot treatment, we tested the effect of sacral neuromodulation (SNM) for four endometriosis patients suffering chronic pelvic pain and pelvic organ dysfunction after radical surgical treatment. Three out of four patients reported improvement in their symptoms during the neuromodulation testing period and a permanent pulse generator was installed. After 2.5 years, all three patients report better quality of life and want to continue with SNM.

Late complications related to palliative stenting in patients with obstructing colorectal cancer.

INTRODUCTION: Self-expanding metal stents (SEMSs) are increasingly used for the palliative treatment of incurable obstructing colorectal cancer. The aim of the current study was to evaluate clinical outcome, including technical and clinical success of stenting, and to identify factors associated with late complications of SEMS in palliation of incurable obstructing colorectal cancer. MATERIAL AND METHODS: Between 2003 and 2010 details of 56 patients who underwent an attempt of SEMS insertion for obstructive incurable colorectal cancer at Turku University Hospital were recorded to our database prospectively and analyzed retrospectively. RESULTS: Technical success was achieved in 42 patients (75%) and clinical success in 39 patients (70%). Late complications related to SEMS occurred in 13 patients (31%). Ten patients (24%) needed re-intervention because of a complication: Eight ostomies, one Hartmann´s procedure due to late perforation and one re-stenting because of stent migration. Three patients with stent-related complications were treated conservatively. Chemotherapy and prolonged survival were risk factors for SEMS-related late complications and re-intervention. CONCLUSION: SEMS insertion is a feasible procedure for the palliative treatment of obstructing colorectal cancer in patients with severe comorbidities and short life expectancy. However, for patients who are candidates for chemotherapy and have a longer life expectancy, other treatment options such as palliative tumor resection should also be considered.

Patient's age should not play a key role in clinical decisions on surgical treatment of rectal cancer.

BACKGROUND AND AIMS: Recent advances in surgical techniques and adjuvant treatments have decreased morbidity and mortality in patients with rectal cancer. The aim of this study was to clarify the effects of aging on the choice, feasibility and safety of various treatment modalities in patients with rectal cancer. PATIENTS AND METHODS: During 2003-2006, a total of 274 rectal cancers were diagnosed at Turku University Central Hospital. Patient and tumor characteristics, treatment modalities chosen, and complications were recorded, and patients were followed up prospectively for 1-3 years after treatment. Patients were then divided into two groups: under 75 (n=181) and 75 years or older (n=93) at the moment of diagnosis. Patient data in the two age groups were analysed and compared with each other. RESULTS: Of the total of 274 patients with rectal cancer, 243 (89%) underwent surgery. The percentage of patients operated was higher (p=0.03) in the younger (92%) than in the older group (83%). The main reasons for non-operative or palliative treatment were severe concomitant diseases and metastasized cancer. Preoperative radiation therapy was given more often (p<0.01) to young (72%) than old (27%) patients. With these selections, there was no difference in 30-day postoperative mortality (1% vs 1%, ns) or postoperative complications (22% vs 34%, ns) between two groups. CONCLUSION: With preoperative selection, patients over 75 with rectal cancer are suitable for major surgery, as morbidity and mortality rates are comparable to those in younger patients.

Adoption of self-expanding metallic stents in the palliative treatment of obstructive colorectal cancer-look out for perforations!

Self-expanding metallic stents (SEMSs) are increasingly used for the palliative treatment of inoperable colorectal cancer. The aim of the current study was to analyze the safety and efficacy of SEMS in the palliative treatment of obstructive colorectal cancer. Between 2003 and 2006, SEMS placement was attempted in 26 patients suffering from inoperable obstructive colorectal cancer. The recovery of the patients and the outcome of this treatment modality were analyzed prospectively. SEMS was successfully inserted in 19 (73%) of 26 patients. In 16 (84%) of these 19 cases, the placement of SEMS was the definitive treatment of colorectal obstruction and no additional surgical palliation was needed. There were 3 (16%) colonic perforations related to stent application. SEMS insertion seems to be an effective alternative in the palliative treatment of patients with malignant colorectal obstruction. However, perforation is a dangerous complication of the procedure.