Introduction

The ORALEV randomized controlled trial demonstrated that preoperative oral antibiotics (OA) before colon surgery reduces surgical-site infections. However, concerns were raised about the potential risk of antibiotic resistance.

Aims & Methods

This study aimed to assess if OA in the ORALEV trial led to increased long-term infection-related complications due to antibiotic resistance.
This is a retrospective analysis of 3-year follow-up data from 529 patients in the ORALEV trial. Primary outcome: risk of infectious complications and antibiotic resistance in patients with vs without OA. Secondary: long-term complications, effect on COVID-19 risk.

Results

	[ALL]	Experimental	Control	p
	N=529	N=264	N=265
Hospital admission due to infection	14 (2.65%)	7 (2.65%)	7 (2.64%)	1.000
Need for antibiotic treatment	8 (1.51%)	3 (1.14%)	5 (1.89%)	0.715
COVID-19	5 (0.95%)	4 (1.52%)	1 (0.38%)	0.218
Long-term complication	16 (3.02%)	4 (1.52%)	12 (4.53%)	0.077
Long-term unplanned surgery	11 (2.08%)	1 (0.38%)	10 (3.77%)	0.015
Any type of hospital readmission	62 (11.7%)	33 (12.5%)	29 (10.9%)	0.674
3-year mortality	47 (8.88%)	24 (9.09%)	23 (8.68%)	0.989
Overall Survival (3-year)	90.6 (95%CI 88.1; 93.2)	90.4 (95%CI 86.8; 94.1)	90.9 (95%CI 87.4; 94.5)	0.819

536 patients from the ORALEV trial were assessed for eligibility, of whom 529 were included (265 no OA vs 264 OA). The incidence of infective complications resulting in hospital admissions (n=7, 2.6% vs n=7, 2.6%, no OA vs OA), antibiotic treatment (n=5, 1.9% vs n=3, 1.1%. p=0.715), and COVID-19 (n=1, 0.4% vs n=4, 1.5% p=0.22) did not differ. Two patients in each group required treatment with carbapenems. No differences were observed between the groups regarding readmissions for any complication (n=29, 10.9% vs n=33, 12.5%, p=0.67). After removing COVID-19 admissions, COPD was associated with need for antibiotic treatment in the long-term (HR 5.13, 95%CI 1.28-20.54) irrespective of OA administration. The rates of postoperative hernia (n=11, 4.1% vs n=4, 1.5% p=0.11) and indication for hernia repair (9/11, 81.8% vs 1/4, 25%, p=0.08) were higher in non-OA group, but not statistically different.

Conclusion

OA do not increase the risk of long-term infective complications and need for advanced antimicrobial treatment. COPD increased the risk of subsequent need for antibiotic treatment. Hernia rates and need for surgical repair might be higher in those patients who did not receive OA.

References

Espin Basany E, Solís-Peña A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, et al. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. lancet Gastroenterol Hepatol. 2020 Aug;5(8):729–38.

Introduction

Prospective evidence of the long-term efficacy of endoscopic submucosal dissection (ESD) for T1 colorectal cancer (CRC) is insufficient.

Aims & Methods

We aimed to evaluate long-term ESD outcomes for T1 CRC, focusing on the risk stratification criteria and necessity of additional surgery.
This large-scale, multicenter, prospective cohort study was conducted by Hiroshima GI Endoscopy Research Group. All consecutive patients who underwent colorectal ESD between January 2014 and December 2018 were included, and those with pathologically confirmed T1 CRC were analyzed. Patients were classified into low-risk and high-risk groups based on histopathological risk factors for lymph node metastasis in JSCCR guidelines. High-risk patients were categorized into those who underwent additional surgery (surgery group) and those who were followed up without surgery (follow-up group).

Results

Among 2357 patients who underwent ESD for 2478 early colorectal neoplasms, 431 were diagnosed with T1 CRC. Ten recurrences (2.6%) and five T1 CRC-associated deaths (1.3%) occurred in the high-risk group, with none in the low-risk group. Five-year cumulative overall and local recurrence rates were significantly higher in the follow-up versus surgery group (7.7% and 1.9%; P=0.019 versus 6.4% and 0%; P<0.001), with no local recurrence in the surgery group. Five-year overall survival was significantly worse in the follow-up group (79.5% and 95.2%; P<0.001), while no significant difference was found in 5-y disease-specific survival (98.5% and 98.5%; P=0.447).

Characteristics	Total (n=383)	Low-risk (n=102)	High-risk (n=281)	P value	High-risk (n=281)		P value
					Follow-up (n=74)	Surgery (n=207)
Followed-up period, mean± SD, months	65.6±15.3	64.3±14.6	66.1±15.5	0.328	63.8±21.8	66.9±12.5	0.139
Mortality, n (%)	46 (12.0)	11 (10.8)	35 (12.5)	0.657	21 (28.4)	14 (6.8)	<0.001
Mortality associated with T1 CRC, n (%)	5 (1.3)	0 (0)	5 (1.8)	0.175	2 (2.7)	3 (1.5)	0.484
Recurrence, n (%)	10 (2.6)	0 (0)	10 (3.6)	0.012	6 (8.1)	4 (1.9)	0.014
Local recurrence	5 (1.3)	0 (0)	5 (1.8)	0.175	5 (6.8)	0 (0)	<0.001
Distant recurrence	6 (1.6)	0 (0)	6 (2.1)	0.137	2 (2.7)	4 (1.9)	0.694
5-year OS, %	91.1	91.2	91.1	0.854	79.7	95.2	<0.001
5-year DSS, %	98.9	100	98.5	0.177	98.4	98.5	0.42

Conclusion

No recurrence or mortality occurred in the low-risk group, suggesting that intensive surveillance may be unnecessary for these patients after curative ESD. Additional surgery could prevent local recurrence for high-risk T1 CRC, supporting a risk-based treatment approach.

Introduction

Gastric mucosal visibility is essential for high-quality upper gastrointestinal (GI) endoscopy. While simethicone and N-acetylcysteine (NAC) have been shown to improve mucosal visibility, the optimal time interval between preparation and endoscopy remains undefined.

Aims & Methods

This randomized controlled trial evaluated the effect of timing on mucosal visibility and explored the upper limit beyond which visibility begins to decline.
In this single-center, randomized controlled trial, adult patients undergoing elective upper GI endoscopy were randomized into four groups: placebo, simethicone + NAC with endoscopy performed after 10–20 minutes, 20–30 minutes, and >30 minutes. The primary outcome was the proportion of patients achieving adequate gastric mucosal visibility (GMV), defined as a score of <7 on a validated visibility scale. A pre-specified subgroup analysis of the >30 minute group was performed by stratifying patients into 20-minute intervals (31–50, 51–70, and 71–90 minutes) to assess the durability of mucosal clarity over time.

Results

Comparison	Adequate gastric mucosal visibility (%)	P
10–20 min vs 20–30 min	27% vs 62%	0.001
10–20 min vs >30 min	27% vs 67%	0.001
10–20 min vs Placebo	27% vs 2.6%	0.001
20–30 min vs >30 min	62% vs 67%	0.174
20–30 min vs Placebo	62% vs 2.6%	0.001

1,140 patients (median age 42years, 63.2% males) were included in the study. Adequate GMV was significantly higher in all preparation groups compared to placebo (p < 0.001). The 20–30 minute and >30 minute groups demonstrated the highest rates of adequate visibility (61.5% and 73.5%, respectively), both significantly superior to the 10–20 minute group (26.9%) and placebo (2.6%). In the >30 minute subgroup analysis, the 31–50 minute interval demonstrated the highest adequacy (73.5%). The 51–70 minute group showed moderate adequacy (52.1%), which was not significantly different from the 20–30 minute group (p = 0.207). However, the 71–90 minute group had reduced adequacy (43.8%) and did not differ significantly from the 10–20 minute group (p = 0.145). No adverse events were reported across study arms.

Conclusion

Endoscopy performed between 20 and 50 minutes after mucosal preparation yields optimal gastric mucosal visibility. A decline in visibility beyond 50 minutes suggests a practical upper limit for endoscopy timing following preparation. These findings support structured, time-sensitive scheduling following mucosal cleansing to enhance procedural quality.

Disclosure

None