Trial reportSurgery today2016
A randomized clinical study on postoperative pain comparing the Polysoft patch to the modified Kugel patch for transinguinal preperitoneal inguinal hernia repair.
Trial report in Surgery today, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Transinguinal preperitoneal (TIPP) versus Lichtenstein for inguinal hernia repair: a systematic review and meta-analysis.Hernia : the journal of hernias and abdominal wall surgery · 2023Pooled it
- Long-term outcomes of single-incision versus multiport laparoscopic totally extra-peritoneal inguinal hernia repair: a single-institution experience of 186 consecutive cases.Surgery today · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe transinguinal preperitoneal approach is a relatively new technique for inguinal hernia repair. Two types of memory-ring mesh are available in Japan: the modified Kugel patch (MK) and the Polysoft patch (PP). We tested the hypothesis that the PP is noninferior to the MK with respect to chronic postoperative pain.
methodsAn unblinded randomized controlled trial was conducted to assess the noninferiority of PP compared to MK with a 5 % noninferiority margin. A total of 442 inguinal hernia patients operated on from November 2010 to December 2012 were included in this study. The primary endpoint was the pain score assessed by the visual analog scale (VAS) (0-1 vs. 2-10) 1 year after surgery.
resultsThe patients were randomized to the PP and MK groups (n = 221 each). One year after surgery, 206 patients (95.4 %) in the PP group and 182 patients (89.6 %) in the MK group rated pain at 0-1 on the VAS scale. According to this rating, the PP group appeared not to be inferior to the MK group (95 % confidence interval, 0.7-10.7 %, P < 0.05). Furthermore, crude superiority tests, adjusting for 1 month of pain, denoted that the outcomes were significantly improved with the PP compared to the MK.
conclusionsThe use of the PP was noninferior to the MK with respect to the severity of postoperative chronic pain scores 12 months after surgery.
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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.