No long-term studies of laparoscopic and open fundoplication were available in 1994.
Dr Thomas Franzén and colleagues from Sweden compared reflux control and side effects after laparoscopic and open fundoplication.
Adult patients with uncomplicated gastro-esophageal reflux (GERD) disease were included.
The research team conducted a prospective randomized clinical trial between laparoscopic and open 360° fundoplication.
Patients with uncomplicated GERD were included with the exception of those with weak peristalsis or suspected short esophagus.
The team reported that 2 senior surgeons, well trained in laparoscopic antireflux surgery, performed the 45 laparoscopic operations.
There were 48 patients who underwent open surgery performed or supervised by 2 other senior surgeons, also well trained in GERD surgery.
Only 1 of the senior surgeons recruited all the patients.
Manometry and 24-h esophageal pH monitoring were performed before operation and 6 months postoperatively.
|4 patients had mild heartburn 6 months after laparoscopy vs 2 after laparotomy|
|Scandanavian Journal of Gastroenterology|
The team noted that manometry also included a short-term reflux test, an acid clearing test and an acid perfusion test.
Symptom evaluation before surgery, 6 moths after and at long-term follow-up was performed by the same surgeon.
Long-term follow-up also included endoscopy.
The researchers noted that 6 months after laparoscopy 4 patients had disabling dysphagia.
None of the patient had disabling dysphagia after laparotomy.
The research team found that 4 patients had mild heartburn 6 months after laparoscopy vs 2 patients after laparotomy.
Between 6 months' follow-up and long-term follow-up, the team noted that 6 patients were reoperated on in the laparoscopy group.
In the laparotomy group, 2 patients were reoperated at long-term follow-up.
The researchers observed that 3 patients operated on with laparotomy had died of intercurrent diseases.
After laparoscopy, at long-term follow-up, 62% of patients were satisfied compared with 91% after laparotomy, a significant difference.
Dr Franzén's team concludes, “Early postoperative reflux control was similar for laparoscopic and conventional fundoplication.”
“At long-term follow-up significantly more patients were satisfied after laparotomy than after laparoscopy.”