Dataset Information

Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial.

ABSTRACT:

Background

Double J (DJ) ureteral stents are commonly inserted after ureteroscopy (URS) procedures for stone treatment. However, stent-related symptoms are still a major issue.

Objective

To determine whether a commercially available pigtail suture stent (PSS) can reduce stent-related symptoms compared to a conventional DJ stent after uncomplicated URS.

Design setting and participants

We designed a randomized, single-blind, parallel-group trial from January to November 2020. The inclusion criteria were stone-free URS without intraprocedural complications. Patients with distal ureteral stones were excluded.

Intervention

Insertion of a PSS or DJ stent after URS.

Outcome measurements and statistical analysis

The primary endpoint was the Urinary Symptom Index score on the Ureteral Stent Symptoms Questionnaire (USSQ) 2 wk after URS. Secondary endpoints were USSQ domain scores and responses to individual USSQ questions at 2 d and 2 wk after surgery.

Results and limitations

A total of 78 patients were randomized and treated according to protocol. The Urinary Symptom Index score (p = 0.004), overall Visual Analogue Scale (VAS) score (p = 0.022), and the percentage of patients complaining of pain (63.9% vs 86.1%, p = 0.029) were significantly in favor of PSS at both 2 d and 2 wk after URS. At 2 d, the VAS score among patients with pain (p = 0.025) and the General Health Index score (p = 0.036) were significantly better in the PSS group. No severe complications occurred in either group. Study limitations are the exclusion of patients with distal ureteral stones and the limited sample size.

Conclusions

PSS significantly reduced stent-related symptoms after URS, in particular urinary symptoms and pain, compared to conventional DJ stents, and showed a good safety profile.

Patient summary

Stents are hollow tubes placed in the passage between the kidney and the bladder (ureter). The standard stent has two coiled ends (double J stent) to keep it in place in both the kidney and the bladder. We tested a commercial stent with two strings at the bladder end (pigtail suture stent) after procedures to remove stones from the upper urinary tract and found that it caused less stent-related symptoms compared to a double J stent.  This trial is registered at Clinicaltrials.gov as NCT03344120.

SUBMITTER: Bosio A

PROVIDER: S-EPMC8317849 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundFlexible endoscopes ability to manipulate the intestinal environment is limited. As a result, complex endolumenal procedures are often technically demanding and result in long procedure times, impacting institutional resources. Single- and double-balloon add-on endoscopic devices have been employed throughout the GI tract to facilitate tissue control e.g., small bowel enteroscopy, with recent reports suggesting a possible colonic utility for complex procedures e.g., ESD. Our objective was to objectively analyze the efficacy of a new double-balloon device in performing ESD.MethodsEx vivo-12 simulated colonic lesions were created in porcine rectum using a standard 40 mm diameter template. Two categories were evaluated, standard cap technique ESD and double-balloon assisted ESD with retraction (ESD-R). Cases were performed sequentially. In vivo-Six, 40 mm lesion ESD-R's were performed in a porcine model. The primary outcomes of this study were total procedure and dissection times.ResultsIn ex vivo studies, the median total procedure time with the double-balloon platform was significantly shorter than the traditional ESD technique (29 ± 18 vs. 57 ± 21 min, p = 0.03). In the in vivo studies, lesions were successfully removed in a mean time of 48 min, with a dissection time of 20 min with no significant complications. Balloon-clip retraction and specimen retrieval capabilities were used in all double-balloon assisted cases. After 6 cases, times were significantly shorter (ex vivo 47 vs. 17 min; in vivo 57 vs. 27 min).ConclusionsWe have demonstrated the development of a unique technical ESD method facilitated by a new double-balloon device. Ex and in vivo investigation demonstrated superiority of ESD-R over the conventional ex vivo method. The DB device provided increased stability, improved visualization and tissue traction, which significantly reduced dissection time. Such an approach may increase safety, improve patient outcomes, and may prevent unnecessary surgeries for benign conditions.

Project description:BackgroundThe lack of countertraction in endoscopic submucosal dissection (ESD) results in increased technical demand and procedure time. Although the suture-pulley method for countertraction has been reported, its effectiveness compared with the traditional ESD technique remains unclear.ObjectiveTo objectively analyze efficacy of countertraction using the suture-pulley method for ESD.DesignProspective ex vivo animal study.SettingAnimal laboratory.InterventionsTwenty simulated gastric lesions were created in porcine stomachs by using a standard circular template 30 mm in diameter. In the control arm (n = 10), ESD was performed by using the standard technique. In the suture-pulley arm (N = 10), a circumferential incision was made, and an endoscopic suturing device was used to place the suture pulley.Main outcome measurementsThe primary outcome of this study was total procedure time.ResultsThe median total procedure time with the suture-pulley method was significantly shorter than the traditional ESD technique (median, 25% to 75%, interquartile range [IQR]: 531 seconds [474.3-549.3 seconds] vs 845 seconds [656.3-1547.5 seconds], P < .001). The median time (IQR) for suture-pulley placement was 160.5 seconds (150.0-168.8 seconds). Although there was a significantly longer procedure time for proximal versus middle/lower stomach lesions with traditional ESD (median, 1601 seconds; IQR, 1547.5-1708.8 seconds vs median, 663 seconds; IQR, 627.5-681.8 seconds; P = .01), there was no significant difference in procedure time for lesions of various locations when using the suture-pulley method. Compared with traditional ESD, the suture-pulley method was less demanding in all categories evaluated by the NASA Task Load Index.LimitationsEx vivo study.ConclusionsThe suture-pulley method facilitates direct visualization of the submucosal layer during ESD and significantly reduces procedure time and technical difficulty. In addition, the benefit of the suture-pulley method was seen for both simple and more complicated ESDs.

Project description:BackgroundMost patients suffer from ureteral stent-related symptoms (USRS) caused by indwelling ureteral stents. Nevertheless, various medications to alleviate discomfort as well as novel stents are continually being developed, and in recent years, some researchers have believed that proper intravesical stent placement can relieve USRS.ObjectiveTo determine appropriate intravesical ureteral stent position may alleviate USRS.MethodsUp to May 1, 2022, the PubMed, Embase, Scopus and Web of Science databases were thoroughly searched, and two independent reviewers included relevant studies that met the PICO (Patient, Intervention, Comparison, Outcome) criteria. Studies methodological quality were assessed by ROB2 and ROBINS-I. Ureteral stent symptom questionnaire (USSQ), international prostate symptom score (IPSS) and quality of life (QoL) was used to quantify the USRS. According to intravesical ureteral stent position, Group A was defined as the contralateral group, that is distal end of ureteral stent crossed the bladder midline, whereas Group B was classified as ipsilateral group, meaning stent end did not cross the midline.ResultsSix studies incorporating a total of 590 patients were eligible. In terms of USSQ score, the meta-analysis showed that contralateral group was associated with a significant increase in USSQ total (MD, 17.55; 95% CI, 12.04 to 23.07; P < 0.001), urinary symptoms (MD, 2.74; 95% CI, 0.48 to 5.01; P = 0.02), general health (MD, 4.04; 95% CI, 2.66 to 5.42; P < 0.001), work performance (MD, 1.36; 95% CI, 0.75 to 1.98; P < 0.001) and additional problems (MD, 0.89; 95% CI, 0.47 to 1.32; P < 0.001) scores while not associated with a significant increase in body pain (MD, 3.13; 95% CI, -0.19 to 6.44; P = 0.06) and sexual matters (MD, 1.01; 95% CI, -0.03 to 2.06; P = 0.06). As for IPSS, although no significant differences in IPSS total (MD, 2.65; 95% CI, -0.24 to 5.54; P = 0.07) or voiding symptoms (MD, -0.84; 95% CI, -3.16 to 1.48; P = 0.48) scores were found, ipsilateral group was associated with a significant decrease in storage symptoms (MD, 1.92; 95% CI, 0.91 to 2.93; P = 0.0002). Furthermore, ipsilateral group was linked to a significant decrease in QoL score (MD, 1.00; 95% CI, 0.18 to 1.82; P = 0.02).ConclusionThis meta-analysis proven that correct intravesical stent position was critical, and patients with stents crossing the midline experienced more severe USRS than those who did not. Further high-quality randomized controlled trials are needed to corroborate our findings.