Surgical endoscopy · 2025
Comparative study between the effect of Nissen fundoplication and Toupet fundoplication on postoperative manometry findings. A randomized control trial study.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Gadalla Edward Atef Youssef, El Serafy Mohamed Ezzat, El Din Abd El Monaem Ayman Hossam, El Sayed Enaam Ali, Abdalla Ashraf Kamal Mohamad
Аннотация
BACKGROUND: Gastro-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.
METHODS: We 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.
RESULTS: Both 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.
CONCLUSIONS: LTF 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.
METHODS: We 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.
RESULTS: Both 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.
CONCLUSIONS: LTF 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.