randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the...

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Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem A. Bemelman, Arie C. van der Ham, Erwin van der Harst, Hok I. Oei, J. F. Smulders, E. W. Steyerberg, Johan F. Lange

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Page 1: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial

Marietta J. O. E. Bertleff, Jens A. Halm, Willem A. Bemelman, Arie C. van der Ham,

Erwin van der Harst, Hok I. Oei, J. F. Smulders, E. W. Steyerberg, Johan F. Lange

Page 2: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

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).

Page 3: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Objective

• The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction using a multicenter randomized trial.

Page 4: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Participants

• The study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated (March 2009 to July 2005).

• A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair.

Page 5: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Participants

• Exclusion criteria:– inability to read the Dutch language patient

information booklet– inability to complete informed consent– prior upper abdominal surgery and current

pregnancy.• After exclusion of 8 patients during the operation,

outcomes were analyzed for laparotomy (n = 49) and for the laparoscopic procedure (n = 52)

Page 6: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Randomization

• Randomization took place by opening a sealed envelope.

• The envelope randomization was based on a computer-generated list provided by the trial statistician.

Page 7: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Surgical Procedure

• All patients received intravenous antibiotics prior to operation and were allocated for Helicobacter pylori eradication therapy.

• The open surgical procedure was performed through an upper abdominal midline incision. Closure of PPU was to be achieved by sutures alone or in combination with an omental patch.

Page 8: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Surgical Procedure

• Laparoscopic repair was performed with the patient and the team set up in the ‘‘French’’ position.

• Trocars were placed at the umbilicus (video scope) and on the left and right midclavicular line above the level of the umbilicus (instruments). If necessary a fourth trocar was placed in the subxiphoid space for lavage or retraction of the liver.

• The rest of the procedure was identical to that described for open repair.

Page 9: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Postoperative Follow-up

• Postoperative pain was scored by means of a visual analog scale (VAS) for pain on days 1, 3, 7, and 28 ranging from 0 (no pain) to 10 (severe pain).

• The days during which opiates were used by the patients were registered.

• All complications, minor and major, and length of hospital stay were monitored.

Page 10: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Statistical analysis

• Data analysis was carried out according to the intention-to- treat principle as established in the trial protocol.

• Data were collected in a database, and statistical analyses were per- formed with the Statistical Package for Social Sciences for Windows (SPSS 15.0, SPSS Inc., Chicago, IL).

• A researcher blinded to the nature of the procedures performed all data analyses.

Page 11: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Methods: Statistical Analysos

• The primary outcome of the trial was duration of hospital stay.– The power analysis was performed on basis of a

reduction in hospital stay by 1.5 days (10–8.5 days from admission) in favor of the laparoscopically treated group using a b of 0.80 and an a of 0.05. This resulted in a trial size of 50 patients per group.

• Null hypotheses were tested two-sided and a P value

of 0.05 or less was considered statistical significant.

Page 12: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Results

Page 13: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Table 1: Baseline Parameters

Page 14: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Table 2. Intraoperative Findings

Page 15: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Intraoperative complications

• Four patients on the laparoscopic group were required to convert to the open surgery group.

• Inability to visualize the ulcer defect because of bleeding (n=1/52)

• Inability to reach the defect because of the perforation in the vicinity of the gastroduodenal ligament and because of dorsal gastric ulcer (n=2/52)

• Inability to find the perforation (n=1/52)

Page 16: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Table 3.Postoperative Complications

Page 17: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Table 4. Duration of Hospital stay

Page 18: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Table 5. Postoperative Pain

Page 19: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Discussions

Page 20: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

• Since eight out of 109 patients were discovered to have a diagnosis different than PPU, this study supported the benefit of using laparoscopy as a diagnostic procedure.

• Conversion rate in the laparoscopy group were much lower than the reported literature (8% vs 60%), although this can be attributed to the fact that only trained and experienced (more than 50 procedures year) participated in the study.

Page 21: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

• Operating time was significantly longer in the laparoscopy group (75min vs 50min) which may be due to the following:– Laparoscopic suturing is more demanding– Longer irrigation procedure

Page 22: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

• This study further support the evidence that laparoscopic correction of PPU causes less postoperative pain.

• This study also proves the cosmetic benefit of laparoscopic surgery because it decreases the awareness or concern of the patients with the appearance of scars, as supported by the VAS scores.

• However, no statistical difference were noted on the hospital stay of both groups.

Page 23: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Conclusion

• This LAMA trial confirm the results of other trials that laparoscopic correction of PPU is safe, feasible for the experienced laparoscopic surgeon, and causes less operative pain.

• Operating time was longer in the laparoscopic group.

• No difference in the length of hospital stay or incidence of postoperative complications.

Page 24: Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial Marietta J. O. E. Bertleff, Jens A. Halm, Willem

Thank You