Evidence map›Paper›PMID 38956630›Full record

ArticleTrials2024

Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial.

Gaoyang Cao, Xinjie Zhang, Fei Wang, Da Man, Lijie Wu, Xuchu Pan, Shan Chen

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

7 authors.

Gaoyang CaoDepartment of Colorectal surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310000, Zhejiang, China.
Xinjie ZhangDepartment of Colorectal surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310000, Zhejiang, China.
Fei WangDepartment of Colorectal surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310000, Zhejiang, China.
Da ManDepartment of Colorectal surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310000, Zhejiang, China.
Lijie WuAcupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, 310000, Zhejiang, China.
Xuchu PanAcupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, 310000, Zhejiang, China.
Shan ChenAcupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, 310000, Zhejiang, China. breezehilly@hotmail.com.

Funding

Medical Science and Technology Project of Zhejiang Province 0222RC177
6 · The paper itself

Abstract

backgroundLow anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT). METHODS AND ANALYSIS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months). DISCUSSION: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.

trial registrationChinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.

Indexed as

Biofeedback, PsychologyFecal IncontinenceMulticenter Studies as TopicPudendal NerveQuality of LifeRandomized Controlled Trials as TopicRectal NeoplasmsTranscutaneous Electric Nerve StimulationAdultAgedChinaDefecationElectromyographyFemaleHumansMaleBiofeedbackLARS scoreLow anterior rectal resection syndrome (LARS)Percutaneous electrical pudendal nerve stimulationQuality of lifeRandomized controlled trialRectal cancer

Identifiers

PMID38956630
PMCPMC11221096

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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.