Evidence map›Paper›PMID 30400725›Full record

Trial reportGut and liver2019

Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study.

Min Seob Kwak, Jae Myung Cha, Hyo-Joon Yang, Dong Il Park, Kyeong Ok Kim, Jun Lee, Jeong Eun Shin, Young-Eun Joo, Jongha Park, Jeong-Sik Byeon and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut and liver, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03112967 (Safety and Efficacy of Low-volume Preparation in the Elderly), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03112967 nacompletednot on this map

Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution vs 4L PEG Dolution

TypeinterventionalSponsorKyung Hee University Hospital at GangdongRan2017 to 2017Enrolled193ConditionsBowel PreparationArmslow-volume preparation, oral sulfate solution, large-volume preparation, 4L polyethylene glycol
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Oral sulfate solution benefits polyp and adenoma detection during colonoscopy: Meta-analysis of randomized controlled trials.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2022
    Pooled it
  3. Trial
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  7. Review
  8. Article
  9. Review
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  11. Acute Gastropathy Associated with Bowel Preparation for Colonoscopy.The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
    Article
  12. Article
  13. [Hyponatremic Seizure after Ingestion of an Oral Sulfate Tablet for Bowel Preparation for Colonoscopy].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022
    Article
  14. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Min Seob KwakDepartment of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
Jae Myung ChaDepartment of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
Hyo-Joon YangDepartment of Internal Medicine, Sungkyunkwan University College of Medicine, Suwon, Korea.
Dong Il ParkDepartment of Internal Medicine, Sungkyunkwan University College of Medicine, Suwon, Korea.
Kyeong Ok KimDepartment of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Jun LeeDepartment of Internal Medicine, Chosun University College of Medicine, Gwangju, Korea.
Jeong Eun ShinDepartment of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.
Young-Eun JooDepartment of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Jongha ParkDepartment of Internal Medicine, Inje University College of Medicine, Gwangju, Korea.
Jeong-Sik ByeonDepartment of Internal Medicine, University of Ulsan College of Medicine, Korea, Gwangju, Korea.
Hyun Gun KimDepartment of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Aims: The use of a low-volume bowel cleansing agent is associated with a greater willingness to undergo repeat colonoscopy. Oral sulfate solution (OSS) is a recently approved low-volume agent; however, its efficacy and safety in the elderly population remain unclear. We aimed to evaluate the efficacy, safety, and acceptability of the OSS preparation, in comparison to those of a standard polyethylene glycol (PEG; 4 L) preparation, in elderly patients. Methods: A multicenter, randomized, investigator-blinded study was conducted. Participants were randomized to receive OSS or 4-L PEG with a split-dose regimen. Bowel cleansing efficacy was assessed using the Boston Bowel Preparation Scale (BBPS). Acceptance, satisfaction, and preparation-related symptoms were recorded. Additionally, blood parameters were analyzed for electrolyte abnormalities and nephrotoxicity. Results: A total of 193 patients were analyzed. No group differences in overall bowel cleansing efficacy were observed, with "adequate"preparations achieved in 95.9% (93/97) and 94.8% (91/96) of patients in the OSS and 4L PEG groups, respectively (p=0.747). However, mean BBPS scores for the entire (p=0.010) and right colon (p=0.001) were significantly higher in the OSS group than in the 4-L PEG group. The severity of clinical adverse events and frequency of acute kidney injury were similarly low, and no clinically meaningful electrolyte changes were identified. Self-reported scores regarding amount (p<0.001) and feeling (p=0.007), as well as overall satisfaction (p=0.001) and willingness to repeat the preparation (92.8% vs 67.7%, p<0.001), were significantly better in the OSS group than in the 4-L PEG group. Conclusions: In elderly individuals, OSS with a split-dose regimen has greater acceptability and comparable efficacy in bowel cleansing compared to 4-L PEG. (Clinical trials registration number: NCT03112967).

Indexed as

Administration, OralAgedCatharticsColonoscopyFemaleHumansMalePatient Acceptance of Health CarePatient SatisfactionPolyethylene GlycolsPreoperative CareSingle-Blind MethodSulfatesCatharticsPolyethylene GlycolsSulfatesAgedCatharticsColonoscopySafetyTreatment outcome

Identifiers

PMID30400725
PMCPMC6430430

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.