Evidence map›Paper›PMID 21910897›Full record

Trial reportBMC surgery2011

Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial).

Daniel C Steinemann, Dimitri A Raptis, Georg Lurje, Christian E Oberkofler, Roland Wyss, Adrian Zehnder, Mickael Lesurtel, René Vonlanthen, Pierre-Alain Clavien, Stefan Breitenstein

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
6.2field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Fewer-than-four ports versus four ports for laparoscopic cholecystectomy.The Cochrane database of systematic reviews · 2014
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  9. Review
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  13. Feasibility of single-port laparoscopic surgery for sigmoid colon and rectal cancers and preoperative assessment of operative difficulty.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2014
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  17. Single-site Nissen fundoplication versus laparoscopic Nissen fundoplication.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
  18. Single-incision laparoscopic Ladd's procedure for intestinal malrotation.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    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

10 authors at 2 institutions in 1 country.

Daniel C SteinemannDepartment of Surgery, Division of Visceral and Transplantation Surgery, University Hospital Zurich, Switzerland. daniel.steinemann@gmx.ch
Dimitri A Raptis
Georg Lurje
Christian E Oberkofler
Roland Wyss
Adrian Zehnder
Mickael Lesurtel
René Vonlanthen
Pierre-Alain Clavien
Stefan Breitenstein
University Hospital of Zurich · CHKantonsspital Winterthur · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEmerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated. METHODS/

designThe SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm. DISCUSSION: The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.

trial registration(clinicaltrial.gov): NCT 01278472.

Indexed as

Body ImagePatient SatisfactionAdultAgedCholecystectomy, LaparoscopicCholecystolithiasisDouble-Blind MethodElective Surgical ProceduresFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesTreatment Outcome

Identifiers

PMID21910897
PMCPMC3189390
OpenAlexW2083564360

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.