Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial.
BACKGROUND
Laparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction.


METHODS
The study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated. A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair. After exclusion of 8 patients during the operation, outcomes were analyzed for laparotomy (n = 49) and for the laparoscopic procedure (n = 52).


RESULTS
Operating time in the laparoscopy group was significantly longer than in the open group (75 min versus 50 min). Differences regarding postoperative dosage of opiates and the visual analog scale (VAS) for pain scoring system were in favor of the laparoscopic procedure. The VAS score on postoperative days 1, 3, and 7 was significant lower (P < 0.05) in the laparoscopic group. Complications were equally distributed. Hospital stay was also comparable: 6.5 days in the laparoscopic group versus 8.0 days in the open group (P = 0.235).


CONCLUSIONS
Laparoscopic repair of PPU is a safe procedure compared with open repair. The results considering postoperative pain favor the laparoscopic procedure.
Department of Plastic and Reconstructive Surgery, Academic Hospital Maastricht, Maastricht, The Netherlands. doc.bert@orange.nl
Mariëtta J O E
MJ
Bertleff
Jens A
JA
Halm
Willem A
WA
Bemelman
Arie C
AC
van der Ham
Erwin
E
van der Harst
Hok I
HI
Oei
J F
JF
Smulders
E W
EW
Steyerberg
Johan F
JF
Lange
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007431:Intraoperative Complications / Q000175:diagnosis / Q000453:epidemiology; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000503:physiopathology*; D010439:Peptic Ulcer Perforation / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology; D011336:Probability; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome