PMID- 28294958
OWN - NLM
STAT- MEDLINE
DCOM- 20170821
LR  - 20171214
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Linking)
VI  - 266
IP  - 1
DP  - 2017 Jul
TI  - Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and 
      Conventional Nissen Fundoplication: A Plea for Patient Counseling and 
      Clarification.
PG  - 23-28
LID - 10.1097/SLA.0000000000002106 [doi]
AB  - OBJECTIVE: 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). BACKGROUND: 
      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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
FAU - Oor, Jelmer E
AU  - Oor JE
AD  - *St. Antonius Hospital, Department of Surgery, Nieuwegein, The Netherlands 
      daggerRadboud University Medical Center, Department of Operation Rooms/Evidence Based 
      Surgery, Nijmegen, The Netherlands double daggerUniversity Medical Center Utrecht, Department 
      of Surgery, Utrecht, The Netherlands.
FAU - Roks, David J
AU  - Roks DJ
FAU - Broeders, Joris A
AU  - Broeders JA
FAU - Hazebroek, Eric J
AU  - Hazebroek EJ
FAU - Gooszen, Hein G
AU  - Gooszen HG
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
SB  - IM
MH  - Adult
MH  - Counseling
MH  - Deglutition Disorders/surgery
MH  - Female
MH  - Follow-Up Studies
MH  - Fundoplication/adverse effects/*methods
MH  - Gastroesophageal Reflux/complications/*surgery
MH  - Humans
MH  - Incisional Hernia/surgery
MH  - Laparoscopy/*methods
MH  - Male
MH  - Middle Aged
MH  - Patient Education as Topic
MH  - Postoperative Complications
MH  - Quality of Life
MH  - Recurrence
MH  - Reoperation
MH  - Treatment Outcome
EDAT- 2017/03/16 06:00
MHDA- 2017/08/22 06:00
CRDT- 2017/03/16 06:00
PHST- 2017/03/16 06:00 [pubmed]
PHST- 2017/08/22 06:00 [medline]
PHST- 2017/03/16 06:00 [entrez]
AID - 10.1097/SLA.0000000000002106 [doi]
PST - ppublish
SO  - Ann Surg. 2017 Jul;266(1):23-28. doi: 10.1097/SLA.0000000000002106.