Evidence map›Paper›PMID 38969995›Full record

Trial reportBMC women's health2024

Clinical efficacy and safety of transvaginal natural orifice transluminal endoscopic surgery for benign adnexal disease: a prospective trial.

Jinbowen Yan, Dan Zhou, Shuo Zhang, Bo Zhang, Xunyuan Tuo, Qingwei Meng, Qiubo Lv

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC women's health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07637201 (Randomised Prospective Comparison of Sexual Function and Postoperative Recovery Following V-NOTES Versus Laparoscopic Bilateral Tubal Ligation and Salpingectomy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT07637201 naactive not recruitingnot on this mapstarted 2025, after this paper: background citation

Randomised Prospective Comparison of Sexual Function and Postoperative Recovery Following V-NOTES Versus Laparoscopic Bilateral Tubal Ligation and Salpingectomy

TypeinterventionalSponsorTepecik Training and Research HospitalRan2025 to 2026Enrolled118ConditionsSexual Function Scores, Postoperative RecoveryArmsV-NOTES Bilateral Tubal Ligation or Salpingectomy, Laparoscopic Bilateral Tubal Ligation or Salpingectomy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
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.

Jinbowen YanDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Dan ZhouDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China. zhoudan_791124@163.com.
Shuo ZhangDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Bo ZhangDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Xunyuan TuoGansu Provincial Maternal and Child Health Center Gansu Provincial Central Hospital, Lanzhou, Gansu, P.R. China.
Qingwei MengDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Qiubo LvDepartment of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.

Funding

Beijing Municipal Science and Technology Commission, Adminitrative Commission of Zhongguancun Science Park Z191100006619018Natural Science Foundation of Gansu Province 21JR1RA041
6 · The paper itself

Abstract

backgroundThere is a scarcity of prospective clinical research evidence regarding the utilization of transvaginal natural orifice translumenal endoscopic surgery (vNOTES) as a treatment option for ovarian cysts. The objective of this study was to assess the feasibility and safety of employing vNOTES for the management of ovarian cysts.

methodsOur study included women between the ages of 18 and 70 who intended to undergo surgical intervention for benign lesions. Stratified blocked randomization was employed to allocate participants into groups. The main objective was to assess whether the assigned group adhered to the recommended surgical technique for ovarian cystectomy or adnexectomy, without any deviation to alternative surgical methods.

resultsA total of 196 patients were included in the study, with all surgeries in each group being conducted according to the assigned procedures. Among them, the ovarian cystectomy layer included 58 cases in the vNOTES group and 58 cases in the conventional laparoscopy (CL) groups. The adnexectomy layer included 40 cases in the vNOTES group and 40 cases in the CL group. Utilizing a sensitivity analysis, the two-sided 95% lower confidence limit was determined to be 5.5% for the disparity in proportions between the vNOTES groups and CL groups. These lower limits fell below the predetermined non-inferiority margin of 10%.

conclusionsThe study findings demonstrate that vNOTES was not inferior to CL in terms of adnexectomy or ovarian cystectomy. vNOTES can be considered a more minimally invasive surgical approach, as it results in reduced postoperative pain, faster recovery, and absence of visible incisions. Overall, vNOTES proves to be a safe, feasible, and less invasive treatment option.

trial registrationThis study retrospectively registered with the China Clinical Trial Registry with the registration number ChiCTR2100052223(22-10-2021).

Indexed as

Natural Orifice Endoscopic SurgeryOvarian CystsAdnexal DiseasesAdolescentAdultAgedFeasibility StudiesFemaleHumansLaparoscopyMiddle AgedProspective StudiesTreatment OutcomeVaginaYoung AdultOvarian cystProspective randomized controlled trialvNOTES

Identifiers

PMID38969995
PMCPMC11225116

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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.