Evidence map›Paper›PMID 29506566›Full record

ArticleTrials2018

Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

Chunbo Li, Zhiyuan Dai, Huimin Shu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 36% 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, 4 citations in OpenAlex.

  1. Trial
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

3 authors at 1 institution in 1 country.

Chunbo LiDepartment of Gynaecology and Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, 536 Changle Road, Shanghai, China.ORCID http://orcid.org/0000-0003-4566-4305
Zhiyuan DaiDepartment of Gynaecology and Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, 536 Changle Road, Shanghai, China. daizhiyuan@51mch.com.
Huimin ShuDepartment of Gynaecology and Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, 536 Changle Road, Shanghai, China.
Shanghai First Maternity and Infant Hospital · CN

Funding

Shanghai Municipal Medical and Health Discipline Construction Projects 2017ZZ02015The grant from Science and Technology Commission of Shanghai Municipality 17411967900The Health and Family Planning Committee of PuDong New Area of Shanghai PW2015D-9
6 · The paper itself

Abstract

backgroundPelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse. As a new surgical technique for POP, a prospective randomized controlled trial comparing the LILS with the standard technique of LSC is necessary. Therefore, we will conduct a trial.

methodsThe trial is a randomized controlled trial. It compares LILS with LSC in women with stage 2 or higher uterine prolapse. The primary outcomes of this study are perioperative parameters, including surgical time, blood loss, intraoperative complications, and hospital stay as well as surgical anatomical results using the pelvic organ prolapse questionnaire (POP-Q) classification at 6 weeks, 6 months, 12 months, and annually till 5 years after surgery. Secondary outcomes are subjective improvement in urogenital symptoms and quality of life, postoperative complications, postoperative recovery, sexual functioning, and cost-effectiveness at each follow-up point. Validated questionnaires will be used and the data will be analyzed according to the intention-to-treat principle. Based on an objective success rate of 90%, a noninferiority margin of 15%, and a dropout of 20%, 107 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The trial is a randomized controlled, multicenter, noninferiority trial that will provide evidence whether the efficacy and safety of LILS is noninferior to LSC in women with symptomatic stage 2 or higher uterine prolapse.

trial registrationChina Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.

Indexed as

LaparoscopyChinaFemaleGynecologic Surgical ProceduresHumansInguinal CanalMulticenter Studies as TopicPostoperative ComplicationsProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRecovery of FunctionRound LigamentsTime FactorsTreatment OutcomeUterine ProlapseLaparoscopic inguinal ligament suspensionLaparoscopic sacrohysteropexyPelvic organ prolapse

Identifiers

PMID29506566
PMCPMC5838885
OpenAlexW2797986635

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.