Evidence map›Paper›PMID 25552236›Full record

Trial reportSurgical endoscopy2015

Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial).

J P J Burgmans, C E H Voorbrood, N Schouten, N Smakman, S Elias, G J Clevers, P H P Davids, E J M M Verleisdonk, M E Hamaker, R K J Simmermacher and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. International guidelines for groin hernia management.Hernia : the journal of hernias and abdominal wall surgery · 2018
    Guideline
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Varying convalescence recommendations after inguinal hernia repair: a systematic scoping review.Hernia : the journal of hernias and abdominal wall surgery · 2022
    Article
  9. Article
  10. Article
  11. Article
  12. Observational
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

11 authors.

J P J BurgmansDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands. iburgmans@diakhuis.nl.
C E H VoorbroodDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.
N SchoutenDepartment of Surgery, Atrium Medical Centre Parkstad, Heerlen, The Netherlands.
N SmakmanDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.
S EliasJulius Centre for Health Sciences and Primary Care, Utrecht, The Netherlands.
G J CleversDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.
P H P DavidsDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.
E J M M VerleisdonkDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.
M E HamakerDepartment of Geriatric Medicine, Diakonessenhuis Utrecht/Zeist, Zeist, The Netherlands.
R K J SimmermacherDepartment of Surgery, UMCU, Utrecht, The Netherlands.
T van DalenDepartment of Surgery, Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce post-operative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair.

methodsIn a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro(®) or a Prolene(®) mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score >3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities.

resultsAt 3-month follow-up, the incidence of pain (NRS 4-10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21-3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months.

conclusionThree months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint.

Indexed as

PolypropylenesSurgical MeshAdolescentAdultAgedAged, 80 and overDouble-Blind MethodEndoscopyFemaleFollow-Up StudiesHernia, InguinalHerniorrhaphyHumansMaleMiddle AgedPain MeasurementPolypropylenesChronic groin painHeavyweight meshLightweight meshMesh awarenessQuality of lifeTEP repair

Identifiers

PMID25552236

What OpenQuestion holds

Textmetadata
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Registered trials

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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.