Oor Jelmer E, Roks David J, Broeders Joris A, Hazebroek Eric J, Gooszen Hein G
*St. Antonius Hospital, Department of Surgery, Nieuwegein, The Netherlands †Radboud University Medical Center, Department of Operation Rooms/Evidence Based Surgery, Nijmegen, The Netherlands ‡University Medical Center Utrecht, Department of Surgery, Utrecht, The Netherlands.
Ann Surg. 2017 Jul;266(1):23-28. doi: 10.1097/SLA.0000000000002106.
To analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD).
LNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling.
Between 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported.
A total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047).
The effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.
分析一项比较腹腔镜尼氏胃底折叠术（LNF）与传统尼氏胃底折叠术（CNF）治疗胃食管反流病（GERD）的随机临床试验的长期结果。
基于积极的短期和中期结果，LNF已取代CNF。随访超过15年的研究很少，但患者咨询迫切需要此类研究。
1997年至1999年期间，177例质子泵抑制剂（PPI）难治性GERD患者被随机分为CNF组或LNF组。报告了17年时反流症状、吞咽困难、总体健康状况、PPI使用情况以及手术再次干预需求的数据。
共纳入111例患者（60例LNF，51例CNF）。LNF和CNF术后17年，90%和95%的患者报告症状缓解，GERD症状或吞咽困难无差异。43%和49%的患者使用PPI（无统计学差异）。两组患者的总体健康状况（77%对71%；无统计学差异）和生活质量（75.3对74.7；无统计学差异）均有显著改善。CNF术后手术再次干预更频繁（18%对45%；P = 0.002），主要是由于切口疝修补（3%对14%；P = 0.047）。
LNF和CNF对症状结局和总体健康状况的影响在术后长达17年仍存在，两种手术方法之间无差异。CNF手术再次干预风险更高，主要是由于切口疝修补。应告知患者，尼氏胃底折叠术后17年，60%的患者停用PPI，16%的患者因复发性GERD和/或吞咽困难需要再次手术。
