Evidence map›Paper›PMID 38902558›Full record

Trial reportHernia : the journal of hernias and abdominal wall surgery2024

A multicenter randomized controlled trial comparing short- and medium-term outcomes of novel biologics and lightweight synthetic mesh for laparoscopic inguinal hernia repair.

P Xue, F Yue, S Li, W Cheng, H Zhou, W Yan, Y Zhou, J Tang, J Li, J Zhang

Abstract readMulticenter StudyRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Hernia : the journal of hernias and abdominal wall surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

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

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

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

P Xue *Department of Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 197 Ruijin Road (No.2), Shanghai, 200025, China.
F Yue *Department of Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 197 Ruijin Road (No.2), Shanghai, 200025, China.
S Li *Department of Surgery, Huadong Hospital, Fudan University, Shanghai, China.
W ChengDepartment of Colorectal Surgery, Shanghai Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China.
H ZhouDepartment of Colorectal Surgery, Shanghai Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China.
W YanDepartment of Colorectal Surgery, Shanghai Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China.
Y ZhouDepartment of Colorectal Surgery, Shanghai Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China.
J TangDepartment of Surgery, Huadong Hospital, Fudan University, Shanghai, China.
J LiDepartment of Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 197 Ruijin Road (No.2), Shanghai, 200025, China. lijianwen0707@163.com.
J ZhangDepartment of Colorectal Surgery, Shanghai Changzheng Hospital, Naval Medical University, 415 Fengyang Road, Shanghai, 200003, China. txzhangjian@126.com.

Funding

National Defense Science and Technology Excellent Youth Science Fund 2019-JCJQ-ZQ-002National Defense Science and Technology Foundation Strengthening Plan 2019-JCJQ-JQ-069
6 · The paper itself

Abstract

introductionThe use of biological graft in laparoscopic inguinal hernia repair (LIHR) has been controversial, and there is a lack of high-level evidence to confirm the value of biological graft in LIHR. The purpose of this study is to evaluate the effectiveness of a novel composite biologics in LIHR.

methodsA multicenter, single-blinded, randomized controlled clinical trial was designed. Fifty patients with unilateral primary inguinal hernia were randomly assigned to the experimental and control group (1:1). The experimental group was repaired with a non-crosslinked composite extracellular matrix from porcine urinary bladder matrix and small intestinal submucosa (UBM/SIS). The control group was repaired with a lightweight, large-pore, synthetic mesh. The primary endpoint was the effectiveness rate of hernia repair.

resultsThe patients were followed up for four years. No significant difference was found between the experimental group and the control group in the effective rate of hernia repair (24/24[100%] vs 21/22[95.45%], RR, 0.4667; 95%CI, 0.3294-2.304; P = 0.4783). There was no fever, seroma, infection, groin pain, foreign body discomfort or recurrence in the experimental group during the follow-up. In the control group, there were 2 cases of seroma 14 days after operation, 1 case of groin discomfort 60 days after operation and one case of recurrence 410 days after surgery.

conclusionCompared with the lightweight synthetic mesh, the novel UBM/SIS graft has comparable short-term and medium-term effectiveness in LIHR, and the incidence of postoperative complications such as seroma groin discomfort is lower. Trial registration Clinical Trials Registry: ChiCTR1800020173.

Indexed as

Hernia, InguinalHerniorrhaphyLaparoscopySurgical MeshAdultAgedBiological ProductsFemaleHumansMaleMiddle AgedSingle-Blind MethodTreatment OutcomeBiological ProductsBiologicsLaparoscopic inguinal hernia repairUBM/SIS composite graft

Identifiers

PMID38902558

What OpenQuestion holds

Textmetadata
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.