Evidence map›Paper›PMID 27049778›Full record

Trial reportJournal of the American College of Surgeons2016

Pilot Randomized Controlled Trial of Laparoscopic Cholecystectomy vs Active Nonoperative Therapy for the Treatment of Biliary Dyskinesia.

Bryan K Richmond, Caresse Grodman, Jerri Walker, Scott Dean, Edward H Tiley, Roland E Hamrick, Kristen Statler, Mary Emmett

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Surgeons, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Biliary Dyskinesia - Is It Real?JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Bryan K RichmondDepartment of Surgery, West Virginia University/Charleston Division, Charleston, WV. Electronic address: brichmond@hsc.wvu.edu.
Caresse GrodmanCharleston Area Medical Center Health Education and Research Institute, Charleston, WV.
Jerri WalkerCharleston Area Medical Center Health Education and Research Institute, Charleston, WV.
Scott DeanCharleston Area Medical Center Health Education and Research Institute, Charleston, WV.
Edward H TileyDepartment of Surgery, West Virginia University/Charleston Division, Charleston, WV.
Roland E HamrickDepartment of Surgery, West Virginia University/Charleston Division, Charleston, WV.
Kristen StatlerDepartment of Surgery, West Virginia University/Charleston Division, Charleston, WV.
Mary EmmettCharleston Area Medical Center Health Education and Research Institute, Charleston, WV.
Charleston Area Medical Center · USUniversity of Charleston · USWest Virginia University · US

Funding

West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI Laura F. Gibson · 2012 to 2026
$81.0M
NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

backgroundDespite widespread adoption by the surgical community, high-quality prospective data supporting the practice of laparoscopic cholecystectomy (LC) for the treatment of biliary dyskinesia (BD) are lacking. STUDY

designAdult patients meeting criteria for diagnosis of BD (Rome III symptoms, normal ultrasound, gallbladder ejection fraction < 38%) were randomized to either LC or a trial of nonoperative (NO) therapy with a low-dose neuromodulator (amitriptyline 25 mg/day). Patients in the NO arm were allowed to cross over to the surgical arm and remain in the study for any reason. Besides collection of basic demographics and medical/surgical history, patients were administered a standardized quality of life (QOL) assessment (Short Form-8) and a symptom-specific questionnaire (Rome III criteria) at enrollment and monthly through the study to assess the effect of treatment on biliary symptoms and overall QOL.

resultsThirty patients were enrolled over 12 months (15 LC, 15 NO). In the LC group, 13 underwent LC, 1 refused surgery, 1 withdrew. In the NO group, 14 crossed over to the LC group (13 of whom had LC), yielding 26 patients who underwent LC. The SF-8 physical scores (PCS-8) were significantly improved at both the first and last follow-up visits (p < 0.0001, p = 0.0003, respectively). The SF-8 mental scores (MCS-8) were also significantly improved at both the first and last follow-up visits (p = 0.0187, p = 0.0017, respectively). With median follow-up of 12 months (range 3 to 14 months), all 26 reported relief of pain.

conclusionsThis pilot study raises doubts regarding the feasibility of a randomized trial, presumably due to both clinician and patient bias toward LC and the lack of "gold-standard" nonoperative treatments. However, these prospective data indicate that, with careful patient selection (standardized symptom criteria/imaging methodology), LC results in pain relief and significant improvement in QOL in BD patients. Further prospective study of these findings is warranted.

Indexed as

Cholecystectomy, LaparoscopicAdolescentAdrenergic Uptake InhibitorsAdultAgedAmitriptylineBiliary DyskinesiaDrug Administration ScheduleFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedPilot ProjectsProspective StudiesAdrenergic Uptake InhibitorsAmitriptyline

Identifiers

PMID27049778
PMCPMC4884483
OpenAlexW2293089887

What OpenQuestion holds

Textmetadata
LicenceTDM
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.