Evidence map›Paper›PMID 35470189›Full record

ArticleBMJ open2022

Effect of partial preservation versus complete preservation of Denonvilliers' fascia on postoperative urogenital function in male patients with low rectal cancer (PREDICTION): protocol of a multicentre, prospective, randomised controlled clinical trial.

Zhifang Zheng, Daoxiong Ye, Xiaojie Wang, Xingrong Lu, Ying Huang, Pan Chi

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 48% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
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.

Zhifang Zheng *Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Daoxiong Ye *Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Xiaojie Wang *Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Xingrong LuDepartment of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Ying HuangDepartment of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China chipan363@163.com hy9033sy@sina.com.
Pan ChiDepartment of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China chipan363@163.com hy9033sy@sina.com.ORCID 0000-0002-0004-1174
Fujian Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTotal mesorectal excision (TME) has been the gold standard for the surgical treatment of mid-low rectal cancer, but traditional TME removal of Denonvilliers' fascia (DVF) is too low and is prone to damage the connecting branches of the bilateral neurovascular bundles, which can lead to posturogenital dysfunction. A recently published multicenter randomised controlled trial revealed that TME with complete preservation of DVF (CP-DVF) has protective effects on postoperative urogenital function for male patients with rectal cancer with specific staging and location (preoperative staging T1-4N0-2M0, but T1-2 for anterior rectal wall). Our previous studies have confirmed that TME with partial preservation of DVF (PP-DVF) could also achieve satisfactory results regardless of the circumferential location of the tumour. However, there is a lack of randomised controlled trials to prove that the efficacy of TME with PP-DVF is equivalent to that with CP-DVF with respect to postoperative urogenital function. METHODS AND ANALYSIS: This study is a prospective, multicentre, equivalent design, open-label randomised clinical trial in which 278 male patients with low rectal cancer will be recruited from 11 large-scale gastrointestinal medical centres in China. Patients will be randomly assigned to undergo PP-DVF or CP-DVF. We will test the hypothesis that PP-DVF is similar to CP-DVF with respect to sexual function at postoperative month 12 (5-item version of the International Erectile Function Index Questionnaire and ejaculation function classification). The secondary outcomes include the assessment of urinary function, surgical safety and oncological outcomes. ETHICS AND DISSEMINATION: This trial has been approved by the Institutional Review Board of Fujian Medical University Union Hospital (2020YF016-01) and is filed on record by all other centres. Written informed consent will be obtained from all eligible participants before enrolment. The trial's results will be disseminated via peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ChiCTR2000034892.

Indexed as

Rectal NeoplasmsFasciaFemaleHumansMaleMargins of ExcisionMulticenter Studies as TopicPostoperative PeriodProspective StudiesRandomized Controlled Trials as TopicColorectal surgeryGastrointestinal tumoursSexual dysfunction

Identifiers

PMID35470189
PMCPMC9039511
OpenAlexW4224923651

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.