Prospective Randomized Trial Comparing Laparoscopic and NOTES Cholecystectomy: Preliminary Results

Introduction: the feasibility of hybrid NOTES cholecystectomy has been demonstrated. The recommendations from the 4th International Conference on NOTES (Boston, 2009) encouraged randomized trials to prove the advantages of this approach.

Methods: Between January and July 2009, a prospective randomized trial of hybrid NOTES cholecystectomy (H-NC) versus laparoscopic cholecystectomy (LC) for patients with symptomatic gallstone disease was undertaken in compliance with our IRB and Ethics Committee´s approval. Mean age was 42.5 years. The inclusion criteria specify: a) Age between 18 and 65 years, b) Previous pregnancy/ies, and negative pregnancy tests, c) Informed consent process, d) Symptomatic gallbladder stones with surgical indication, e) Absence of common bile obstruction, f) Body mass index below 25, j) Non relevant ultrasound findings. The patients were allocated randomly in 2 groups of 20 patients each: Group I (LC): a laparoscopic cholecystectomy was performed with a 3 5 mm trocars and in cases, an additional 2 mm forceps for retraction of the gallbladder fundus was used. Group II (H-NC): placement of a 5 mm umbilical trocar for insuflation and visualization, insertion of a 2 channel trocar through the right posterior vaginal cul de sac and introduction of a flexible videoendoscope (Olympus GIF-160) and long forceps and diverse instruments (Novare®). Disecction of the cystic elements (duct and artery) and the Calot´s triangle was performed with electrocautery, scissors and Maryland forceps through the umbilical port, in a laparoscopic fashion as well as the ligaclip instrument. Removal of the gallbladder through the vagina using an endoscopic loop placed at its neck. The access was closed with a running suture of absorbable vycril 2/0 from the vagina. Antibiotic prophylaxis was used with cefazolin 1g before anesthetic induction and post-operative analgesia was standardized for the 2 groups.

Results: 1) the procedure was completed as intended in both groups, 2) Mean operative time was 38 +/- 8.5 minutes for LC and 56 +/- 12 for H-NC, 3) Length of stay was similar for both groups, 4) No intraoperative complications were achieved, 5) In two of the H-NC an additional 2 mm forceps was required, 6) No infectious or parietal complications developed during follow-up, 7) Postoperative pain was less in the N-HC group as well as the need for additional painkiller medication, but not statistically significant, 8) Cosmetic results were excellent in the H-NC group, 9) Patients´ preferences were inclined to the H-NC procedure and 10) 9) Return to work was in average 39 hours earlier for the H-NC.

Conclusions: Our initial results conclude that H-NC is superior to LC for less postoperative pain and better cosmetic results, though it is associated with longer operative time and additional instruments. Nonetheless, H- NC can be performed safely and has an excellent outcome and high patient acceptability, comparable to LC for the treatment of cholelithiasis and intraoperative complications and total hospital stay.

Session: Podium Presentation

Program Number: S040

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