Low anterior resection syndrome after rectal resection management: multicentre randomized clinical trial of transanal irrigation with a dedicated device (cone catheter) versus conservative bowel management.
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SUBMITTER: Meurette G
PROVIDER: S-EPMC10416684 | biostudies-literature | 2023 Aug
REPOSITORIES: biostudies-literature
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Low anterior resection syndrome after rectal resection management: multicentre randomized clinical trial of transanal irrigation with a dedicated device (cone catheter) versus conservative bowel management.
Meurette Guillaume G Faucheron Jean-Luc JL Cotte Eddy E Denost Quentin Q Portier Guillaume G Loriau Jerôme J Hansen Andreas Wolff AW Vicaut Eric E Lakkis Zaher Z
The British journal of surgery 20230801 9
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Project description:IntroductionRectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to bowel function known as low anterior resection syndrome (LARS). There are currently no clear guidelines on the management of LARS with only limited evidence for different treatment modalities.Methods and analysisPatients who have undergone an anterior resection for rectal cancer in the last 10 years will be approached for the study. The feasibility trial will take place in four centres with a 9-month recruitment window and 12 months follow-up period. The primary objective is to assess the feasibility of recruitment to the POLARiS trial which will be achieved through assessment of recruitment, retainment and follow-up rates as well as the prevalence of major LARS.Feasibility outcomes will be analysed descriptively through the estimation of proportions with confidence intervals. Longitudinal patient reported outcome measures will be analysed according to scoring manuals and presented descriptively with reporting graphically over time.Ethics and disseminationEthical approval has been granted by Wales REC1; Reference 22/WA/0025. The feasibility study is in the process of set up. The results of the feasibility trial will feed into the design of an expanded, international trial.Trial registration numberCT05319054.
| S-EPMC9835955 | biostudies-literature
Project description:PurposeThe aim of the study was to explore long-term experiences of transanal irrigation (TAI) in patients with major low anterior resection syndrome (LARS).MethodsThe study included a qualitative and quantitative analysis of patients who developed major LARS after rectal cancer surgery between 2016 and 2019 and have undergone treatment with TAI. The patients received questionnaires. Mean scores were calculated with time-to-deterioration. Individual semi-structured interviews were performed and analyzed, according to Graneheim and Lundman with patients who performed TAI regularly for more than one year.ResultsIn total 28 out of 39 patients responded to the questionnaires and 16 patients participated in the interviews. At mean 6-years follow-up, a 9.4 points difference in mean LARS score was obtained, (21.2 vs. 30.7) indicating less LARS symptoms in favor of the TAI treatment. Patients in the TAI group used less loperamide compared to the control group (36% vs. 79%). The use of bulky agents was similar. The interview text rendered into three main categories: regaining control in everyday life, need for structure and planning and becoming familiar with the procedure.ConclusionsTreatment with TAI showed the potential to improve the quality of life of patients with major LARS. The improvements in their general well-being were valued over adjustments and time spent on TAI.Implications for cancer survivorsBowel dysfunction remains after 6-years with lower LARS scores favoring the TAI treatment. In the absence of a definitive treatment, survivors of rectal cancer coping with LARS have shown appreciation of the TAI treatment.
| S-EPMC11804026 | biostudies-literature
Project description:The gold standard of surgical technique for rectal cancer is total mesorectal excision (TME). Laparoscopic TME has been proven to provide surgical safety and oncological outcomes equivalent to open TME. However, dissection of the lower rectum has some inherent difficulties related to a narrow pelvic space. The challenge of TME in the lower rectum was confirmed by the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial showing a 9% positive circumferential margin (CRM) rate in laparoscopic TME and a 22% positive CRM rate in open TME. Recently, transanal TME has attracted intense attention as a promising alternative to laparoscopic TME. In this video article, we show the performance of a transanal approach for intersphincteric resection (ISR) of rectal cancer in a patient with a huge prostatic hypertrophy.
| S-EPMC6498383 | biostudies-literature
Project description:Robotic transanal surgery is the culmination of major developments in rectal cancer management and minimally invasive surgery. It is the result of continuous efforts to tackle the challenges inherent to rectal cancer surgery. This latest technology holds great promise and excitement for the care of the rectal cancer patient. In this article, we will describe the evolution of transanal rectal cancer surgery and describe how the convergence of transanal transabdominal, transanal endoscopic microsurgery, transanal minimally invasive surgery (TAMIS), transanal total mesorectal excision (taTME), and the different robotic platforms have culminated in the development of single port robotic transanal minimally invasive surgery (SP rTAMIS) and single port robotic transanal total mesorectal excision (SP rtaTME). We will describe the indications, technical aspects, outcomes, benefits, and limitations of the SP rTAMIS and SP rtaTME.
| S-EPMC8428981 | biostudies-literature
Project description:PurposeLocal treatment of small well-differentiated rectal neuroendocrine tumors (NETs) is recommended by current guidelines. However, although several endoscopic methods have been established, the highest R0 rate is achieved by transanal endoscopic microsurgery (TEM). Since a recently published study about endoscopic full thickness resection (eFTR) showed a R0 resection rate of 100%, the aim of this study was to evaluate both methods (eFTR vs. TEM).MethodsWe retrospectively analyzed all patients with rectal NET treated either by TEM (1999-2018) or eFTR (2016-2019) in two tertiary centers (University Hospital Wuerzburg and Ulm). We analyzed clinical, procedural, and histopathological outcomes in both groups.ResultsTwenty-eight patients with rectal NET received local treatment (TEM: 13; eFTR: 15). Most tumors were at stage T1a and grade G1 or G2 (in the TEM group two G3 NETs were staged T2 after neoadjuvant chemotherapy). In both groups, similar outcomes for en bloc resection rate, R0 resection rate, tumor size, or specimen size were found. No procedural adverse events were noted. Mean procedure time in the TEM group was 48.9 min and 19.2 min in the eFTR group.ConclusioneFTR is a convincing method for local treatment of small rectal NETs combining high safety and efficacy with short interventional time.
| S-EPMC8026435 | biostudies-literature
Project description:BackgroundThe aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set.MethodsAn interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study's primary efficacy criterion was successful TAI, defined as (i) use of the patient's usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety.ResultsFifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device.ConclusionsIn patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.
| S-EPMC7297826 | biostudies-literature
Project description:PurposeTransanal endoscopic microsurgery (TEM) is the most standardized method for the local excision of rectal neoplasms. Unfortunately, local excisions of rectal lesions by means of TEM are not completely free from undesirable functional sequela. This study was performed to evaluate the risk factors of major loss of function after TEM.MethodsEighty-nine patients underwent TEM between 2019 and 2020. Anorectal manometry was performed before the surgery and 3, 6, and 12 months after the surgery. The quality of life (QoL) was assessed using the Fecal Incontinence Quality of Life scale.ResultsThe major decrease in QoL was observed in women in 3 months after the surgery in terms of lifestyle and frustration domains (3.6 and 3.64 points, respectively). In 3 months after the surgery, there was a significant decrease in resting pressure both in male and female patients (P=0.01). This difference remained significant 6 months after the surgery (P=0.01). In 12 months after the surgery, resting pressure returned to the preoperative level in most patients (P=0.50). A significant decrease in manometric parameters appeared when the surgery time is more than 55 minutes (P=0.05), the tumor localization is lower than 3 cm from the anus (P=0.03), and the tumor size is over 3 cm (P=0.001).ConclusionThe most significant risk factors for the development of functional disorders after TEM are surgery time of >55 minutes, tumor localization at <3 cm from the anal verge, and tumor size of >3 cm.
| S-EPMC10475803 | biostudies-literature
Project description:BACKGROUND:Despite clinical guidelines classifying T2 rectal cancer as a contraindication for transanal local excision attributable to unacceptably high rates of local recurrence, it is a practice that persists clinically. Recent clinical trials have suggested that transanal local excision in addition to neoadjuvant chemoradiation is an acceptable alternative in select patients. METHODS:The 2004-2015 National Cancer Database was queried for patients with clinical stage T2N0M0 rectal adenocarcinoma who underwent surgical intervention. Patients were stratified by treatment with transabdominal resection or transanal local excision, both with and without neoadjuvant chemoradiation. Propensity matching was performed, and, using the Kaplan-Meier and Cox proportional hazard models, survival was compared between the groups. RESULTS:A total of 12,021 patients met inclusion criteria, including 1,761 and 6,629 patients who underwent transabdominal resection with and without neoadjuvant chemoradiation, respectively, and 695 and 2,936 patients who underwent local transanal excision with and without neoadjuvant chemoradiation, respectively. In unadjusted analysis, patients undergoing induction therapy followed by transabdominal resection or local excision had equivalent survival. Similarly, on multivariate Cox proportional hazard regression after propensity matching, local excision was not an independent predictor of patient mortality compared with transabdominal resection (hazard ratio 0.93, 95% confidence interval 0.75-1.16). CONCLUSION:Local transanal excision in addition to neoadjuvant chemoradiation may provide comparable survival benefit to transabdominal resection for patients with clinical stage T2N0M0 rectal cancer. Therefore, patients who refuse or are poor candidates for transabdominal resection should be considered for neoadjuvant therapy followed by transanal local excision.
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Project description:ObjectiveNeurologic bowel incontinence and dysfunction are common with Cauda Equina Syndrome (CES). The study objective was to evaluate the efficacy of Peristeen Anal Irrigation System (PAIS)TM in people with CES.DesignClinical Trial.SettingSpinal Cord Rehabilitation outpatient clinic at the Health Sciences Centre in Winnipeg.MethodsTwelve participants with a mean age of 46.2 years (range 34-72 years, 4 females) with CES used PAISTM bowel routine for 10 weeks.Outcome measuresChange in Neurogenic Bowel Dysfunction Score (NBD) over 10 weeks relative to baseline. Secondary outcomes: Change in St. Mark's Fecal Incontinence score (SMFI), Cleveland Clinic Constipation score (CCC), and modified Rectal Surgeons Fecal Incontinence Quality of Life Score (QOL) at week 1, 2, 4, 6, 8 and 10 compared to baseline, and self-rating of bowel function at baseline and 10 weeks. Additionally, colonic transit times were assessed using the radioactive markers (Sitzmarks) method.ResultsTen participants completed the study. Post-intervention primary outcome NBD score improved (p < 0.01). Secondary outcomes also improved significantly, including SMFI (p < 0.01), CCC (p < 0.01), QOL (p < 0.01), self-rating of bowel function (p < 0.01), and transit time improved by 22% (p < 0.05).ConclusionOverall, a significant improvement was observed with the PAISTM for both primary, as well as secondary outcome measures, without any significant adverse effects. As this non-pharmaceutical method of bowel management is effective and has the potential to improve symptoms of bowel dysfunction in people with CES, it should be considered for those in which traditional methods of managing neurogenic bowel fail.
| S-EPMC10885772 | biostudies-literature
Project description:AimTo evaluate the efficacy and safety of simple TaTNE in the treatment of low rectal cancer compared with laparoscopic transabdominal TME.MethodsWe collected patients with low rectal cancer admitted to our hospital between January 2019 and November 2021 who received simple TaTME or laparoscopic transabdominal TME. The main outcome was the integrity of the TME specimen. Secondary outcomes were the number of lymph nodes dissected, intraoperative blood loss, operative time, surgical conversion rate, Specimen resection length, circumferential margin (CRM), and distal resection margin (DRM), complication rate. In addition, the Wexner score and LARS score of fecal incontinence were performed in postoperative follow-up.ResultsPathological tissues were successfully resected in all patients. all circumferential margins of the specimen were negative. Specimen resection length was not statistically significant (9.94 ± 2.85 vs. 8.90 ± 2.49, P > 0.05). The incidence of postoperative complications in group A (n = 0) was significantly lower than that in group B (n = 3) (P > 0.05). There was no significant difference in operation time between group A and group B (296 ± 60.36 vs. 305 ± 58.28, P > 0.05). Among the patients with follow-up time less than 1 year, there was no significant difference in Wexner score and LARS score between group A and group B (P > 0.05). However, in patients who were followed up for more than 1 year, the Wexner score in group A (9.25 ± 2.73) was significantly lower than that in group B (17.36 ± 10.95) and was statistically significant (P < 0.05).ConclusionFor radical resection of low rectal cancer, Simple TaTME resection may be as safe and effective as laparoscopic transabdominal TME, and the long-term prognosis may be better.
| S-EPMC10413134 | biostudies-literature