Evidence map›Paper›PMID 40858943›Full record

Trial reportSurgical endoscopy2025

Comparative study between the effect of Nissen fundoplication and Toupet fundoplication on postoperative manometry findings. A randomized control trial study.

Edward Atef Youssef Gadalla, Mohamed Ezzat El Serafy, Ayman Hossam El Din Abd El Monaem, Enaam Ali El Sayed, Ashraf Kamal Mohamad Abdalla

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05432109, which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from 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.

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.

NCT05432109 no registry record found
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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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

5 authors.

Edward Atef Youssef GadallaGeneral Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. edward.attef@med.asu.edu.eg.ORCID http://orcid.org/0009-0002-7119-8045
Mohamed Ezzat El SerafyGeneral Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ayman Hossam El Din Abd El MonaemGeneral Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Enaam Ali El SayedTropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ashraf Kamal Mohamad AbdallaGeneral Surgery Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGastro-esophageal reflux disease (GERD) impairs quality of life and may require surgery when medical treatment fails. Laparoscopic Nissen fundoplication (LNF) is the traditional gold-standard, whereas laparoscopic Toupet fundoplication (LTF) may provide comparable reflux control with fewer motility-related side-effects.

methodsWe conducted a single-center, parallel-group, randomized controlled trial (ClinicalTrials.gov identifier: NCT05432109) at Ain Shams University Hospitals. Twenty adults with medically refractory GERD were randomized (1:1) to LNF or LTF. Primary outcome was change in lower esophageal sphincter (LES) pressure measured by high-resolution manometry (HRM) 6 weeks post-operatively. Secondary outcomes included distal contractile integral (DCI), largest break size, distal latency (DL), hiatus hernia resolution, GERD Health-Related Quality of Life (GERD-HRQL) score, and adverse events. Analyses followed CONSORT guidelines and utilized an intention-to-treat approach.

resultsBoth procedures significantly increased median LES pressure (LNF: + 12 mmHg; LTF: + 10 mmHg, p < 0.001 each). LTF produced greater improvement in largest break size (- 1.60 cm vs. - 1.00 cm; p = 0.013) and GERD-HRQL (median reduction - 3 vs. - 2; p = 0.019). DCI rose more after LTF (+ 710 vs. + 225 mmHg s cm; p = 0.051). Early dysphagia occurred in 40% of LNF versus 10% of LTF patients, while gas-bloat syndrome occurred in 30% vs. 0% (p = 0.07 and 0.04, respectively). No serious adverse events were observed.

conclusionsLTF provided equivalent reflux control, superior motility preservation, and fewer early obstructive symptoms compared with LNF. LTF should be considered the preferred anti-reflux procedure, particularly in patients with borderline esophageal motility. Larger multicenter trials with longer follow-up are warranted.

Indexed as

FundoplicationGastroesophageal RefluxLaparoscopyAdultAgedEsophageal Sphincter, LowerFemaleHumansMaleManometryMiddle AgedQuality of LifeTreatment OutcomeAnti-reflux surgeryGERDHigh-resolution manometryNissen fundoplicationRandomized controlled trialToupet fundoplication

Identifiers

PMID40858943
PMCPMC12618373

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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.