OBJECTIVE:To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia.
BACKGROUND:The role of watchful ...waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established.
METHODS:In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates.
RESULTS:Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 95% confidence interval (CI) 0.28–0.41) in the elective repair group and 0.58 (95% CI 0.52–0.64) in the watchful waiting group. The difference of these means (MD) was −0.23 (95% CI −0.32 to −0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively).
CONCLUSIONS:Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older.
Background. Intraoperative decision of the level of distal resection in rectal cancer is often imprecise, based exclusively on digital examination and pretherapeutic imaging. Design. Prospective, ...single institution, nonrandomized trial (ClinicalTrial.gov identification no. NCT01887509) to evaluate the contribution of probe-based confocal laser endomicroscopy (pCLE) to establish the optimal resection margin of rectal adenocarcinoma. The primary outcome was the concordance in the identification of lower tumor margins between pCLE and histopathology. For each patient, pCLE examination was performed on nonneoplastic and neoplastic aspects of the distal tumor margin, before and after neoadjuvant chemoradiation, or preceding surgery, if chemoradiation was not required. Biopsies were taken at the same locations. The intraclass correlation coefficient was determined. Results. Twenty-one patients were enrolled. Thirteen patients completed the full study. Six patients completed imaging only before chemoradiation. Two patients retracted their consent after inclusion. A total of 134 videos and corresponding histopathology samplings were analyzed. The sensitivity and specificity of in vivo pCLE interpretation were 0.915 (95% confidence interval CI = 0.840-0.970) and 0.736 (95% CI = 0.657-0.821), respectively. The sensitivity and specificity of the blinded pCLE reinterpretation were 0.930 (95% CI = 0.858-0.980) and 0.688 (95% CI = 0.600-0.770), respectively. No deep layer tumor infiltration was encountered in the samplings with superficial healthy layers. The intraclass correlation coefficient for in vivo pCLE interpretation and blinded pCLE reinterpretation were 0.747 (95% CI = 0.257-0.993) and 0.766 (95% CI = 0.280-0.995), respectively. Conclusions. This supports the concordance between pCLE and histopathology in identifying the “tumor-free” limit of a rectal tumor preceding resection.
Background Open mesh or non-mesh inguinal hernia repair may influence the incidence of chronic postoperative pain differently. Methods A total of 300 patients scheduled for repair of a primary ...unilateral inguinal hernia were randomized to non-mesh or mesh repair. The primary outcome measure was clinical outcome including persistent pain and discomfort interfering with daily activity. Long-term results at 3 years of follow-up have been published. Included here are 10-year follow-up results with respect to pain. Results Of the 300 patients, 87 patients (30%) died and 49 patients (17%) were lost to follow-up. A total of 153 were physically examined in the outpatient clinic after a median long-term follow-up of 129 months (range, 109 to 148 months). None of the patients in the non-mesh or mesh group suffered from persistent pain and discomfort interfering with daily activity. Conclusions Our 10-year follow-up study provides evidence that mesh repair of inguinal hernia is equal to non-mesh repair with respect to long-term persistent pain and discomfort interfering with daily activity. An important new finding from the patient’s perspective is that chronic postoperative pain seems to dissipate over time.
Acute resection for left-sided obstructive colon carcinoma is thought to be associated with higher mortality risk than a bridge to surgery approach using decompressing stoma or self-expandable metal ...stent, but prediction models are lacking.
Determine the influence of treatment strategy on mortality within 90-days from first intervention using a prediction model in patients presenting with left-sided obstructive colon carcinoma.
A national multicenter cohort study, using data of a prospective national audit.
The study was performed in 75 Dutch hospital.
Patients were included if they underwent a resection with curative intent for left-sided obstructive colon carcinoma between 2009 and 2016.
First intervention was either acute resection, bridge to surgery with self-expandable metallic stent, or bridge to surgery with decompressing stoma.
The main outcome measure was 90-day mortality after first intervention. Risk factors were identified using multivariable logistic analysis. Subsequently a risk model was developed.
In total 2395 patients were included, with first intervention consisting of acute resection in 1848 (77%) patients, stoma as bridge to surgery in 332 (14%) patients, and stent as bridge to surgery in 215 (9%) patients. Overall, 152 patients (6.3%) died within 90-days from first intervention. A decompressing stoma was independently associated with a lower 90-day mortality risk (HR: 0.27, CI: 0.094-0.62). Other independent predictors for mortality were age, ASA classification, tumor location, and index levels of serum creatinine and C-reactive protein. The constructed risk model had an area under the curve of 0.84 (CI: 0.81-0.87).
Only patients that underwent surgical resection were included.
Treatment strategy had a significant impact on 90-day mortality. A decompressing stoma considerably lowers the risk of mortality, especially in older and frail patients. A risk model was developed, which needs further external validation. See Video Abstract at http://links.lww.com/DCR/B975.
Background The incidence of incisional hernia after abdominal wall closure is high. Furthermore, recurrence is a significant complication after correction of all abdominal wall hernias. Besides ...surgeon- and patient-related factors, in this experimental study a third factor, i.e., creep behavior of suture materials, is introduced and evaluated. Materials and methods Creep measurements were performed on 0 and 2-0 Prolene (Ethicon, Johnson & Johnson Intl., Somerville, NJ) and 1 and 2-0 PDSII (Ethicon, Johnson & Johnson Intl.) sutures. Two different loads were used representing normal intra-abdominal pressure (IAP) and pathological IAP. A mean percentage of elongation was calculated for each type of suture material. Statistical analysis was performed using analysis of variance. Results All suture materials showed significant (3–51%) creep behavior. Prolene sutures showed more creep than PDSII sutures in both loading conditions. Conclusions As significant creep was demonstrated for commonly used suture materials, creep might be a significant influential factor with regard to the etiology of incisional hernias and recurrence after abdominal wall hernia repair.
Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly ...symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.
In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629.
Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%).
During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.
The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.
INTRODUCTION:Technical difficulty and unfamiliar surgical anatomy are the main challenges in transanal total mesorectal excision. Precise 3-dimensional real-time image guidance may facilitate the ...safety, accuracy, and efficiency of transanal total mesorectal excision.
TECHNIQUE:A preoperative CT was obtained with 10 skin fiducials and further processed to emphasize the border of the anatomical structure by 3-dimensional modeling and pelvic organ segmentation. A forced sacral tilt by placing a 10-degree wedge under the patient’s sacrum was induced to minimize pelvic organ movement caused by lithotomy position. An optical navigation system with cranial software was used. Preoperative CT images were loaded into the navigation system, and patient tracker was mounted onto the iliac bone. Once the patient-to-image paired point registration using skin fiducials was completed, the laparoscopic instrument mounted with instrument tracker was calibrated for instrument tracking. After validating the experimental setup and process of registration by navigating laparoscopic anterior resection, stereotactic navigation for transanal total mesorectal excision was performed in the low rectal neuroendocrine tumor.
RESULTS:The fiducial registration error was 1.7 mm. The accuracy of target positioning was sufficient at less than 3 mm (1.8 ± 0.9 mm). Qualitative assessment using a Likert scale was well matched between the 2 observers. Of the 20 scores, 19 were judged as 4 (very good) or 5 (excellent). There was no statistical difference between mean Likert scales of the abdominal or transanal landmarks (4.4 ± 0.5 vs 4.3 ± 1.0, p = 0.965).
CONCLUSIONS:Application of an existing navigation system to transanal total mesorectal excision for a low rectal tumor is feasible. The acceptable accuracy of target positioning justifies its clinical use. Further research is needed to prove the clinical need for the procedure and its impact on clinical outcomes.
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