Evidence map›Paper›PMID 31300019›Full record

ArticleTrials2019

Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial.

Shi Chen, Dong-Wen Chen, Xi-Jie Chen, Yi-Jia Lin, Jun Xiang, Jun Sheng Peng

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02763878 (Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% of its field
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.

NCT02763878 phase3unknown statusnot on this map

Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2016 to 2020Enrolled832ConditionsNutrition Disorders, Postoperative ComplicationsArmsUncut Roux-en-Y anastomosis, Billroth II anastomosis
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. Current clinical trials on gastric cancer surgery in China.World journal of gastrointestinal oncology · 2024
    Review
  4. Nomogram for predicting early complications after distal gastrectomy.World journal of gastrointestinal surgery · 2023
    Article
  5. Article
  6. Review
  7. Article
  8. Review
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

6 authors at 1 institution in 1 country.

Shi ChenThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China.
Dong-Wen ChenThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China.
Xi-Jie ChenThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China.
Yi-Jia LinThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China.
Jun XiangThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China.
Jun Sheng PengThe Sixth Affiliated Hospital, Sun Yat-sen University, No 26, YuanCun ErHeng Road, TianHe District, Guangzhou, 510655, China. pengjunsheng@tom.com.ORCID http://orcid.org/0000-0002-7975-4176
Sun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGastric cancer is the fourth most common malignant disease worldwide, with lower one-third gastric cancer the most common type. Distal gastrectomy with D2 lymph node dissection was recommended as a standard surgery for distal gastric cancer patients. However, some controversy remains about the anastomosis of the residual stomach and the intestine. The objectives of this trial are to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more effectively than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy. METHODS/

designThis multi-center, prospective, phase III, randomized controlled trial will compare the efficacy of uncut Roux-en-Y anastomosis versus Billroth II anastomosis in phase I-III patients with initial treatment of radical distal gastrectomy. Patients will be randomized to undergo either the intervention (uncut Roux-en-Y anastomosis) or the control (Billroth II anastomosis). We will recruit 832 patients who meet the trial eligibility criteria and will follow the patients after surgery to observe postoperative complications and nutrition status for 5 years. The primary assessment indices of the study are reflux gastritis, esophagitis, bile regurgitation, and anastomotic ulcer. The secondary assessment indices are nutritional status, quality of life, perioperative complications, overall survival rate, and others. When the number of cases reaches 400, an interim analysis will be performed to identify any evidence of definite superiority of the experimental intervention. DISCUSSION: We aim to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy. The results of the trial will contribute to the best evidence on which to base the reconstruction of distal gastrectomy.

trial registrationChinese Southern Gastric Cancer Conference CSGC002 Trial. ClinicalTrials.gov, NCT02763878 . Registered on 5 May 2016.

Indexed as

GastrectomyNutritional StatusAdolescentAdultAgedAnastomosis, Roux-en-YChinaClinical Trials, Phase III as TopicEquivalence Trials as TopicFemaleGastroenterostomyHumansMaleMiddle AgedMulticenter Studies as TopicPostoperative ComplicationsBillroth II anastomosisD2 distal gastrectomyNutritional statusUncut Roux-en-Y anastomosis

Identifiers

PMID31300019
PMCPMC6626339
OpenAlexW2960871150

What OpenQuestion holds

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LicenceCC BY
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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.