Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction

A Multicenter, Prospective, Randomized, Controlled Trial

Ville Sallinen; Heidi Wikström; Mikael Victorzon; Paulina Salminen; Vesa Koivukangas; Eija Haukijärvi; Berndt Enholm; Ari Leppäniemi; Panu Mentula

Disclosures

BMC Surg. 2014;14(77) 

In This Article

Discussion

While laparoscopy has become the treatment-of-choice in acute cholecystitis, acute appendicitis, and perforated peptic ulcer, there are still areas of emergency surgery that are under debate.[6,7] It has been suggested that purulent peritonitis caused by acute diverticulitis can be treated by laparoscopic lavage,[8] and randomized studies are on their way to either prove or disprove this approach.[9,10]

As laparoscopic surgery is becoming more common in emergency surgery, adhesive SBO is the obvious next target for a laparoscopic approach.[1] Although there are several retrospective series, and meta-analyses comparing open approach to laparoscopy, there are no prospective, randomized studies. A search for ongoing trials reveals that, except for this trial, there are no other prospective, randomized trials enrolling patients at the moment of writing. Although previous retrospective series have shown association of less complications and shorter hospital stay with the laparoscopic approach, all previous retrospective series are more or less biased as the easiest cases are selected for laparoscopic approach.

This trial aims to provide level Ib evidence for the use of laparoscopy in the treatment of adhesive SBO that is not resolving by conservative means. Two large meta-analyses have shown that the advancement of oral contrast agent (Gastrografin) to the colon predicts that the obstruction would resolve with 0.97 sensitivity and 0.96 speficity.[5,11] Optimal timing of the abdominal radiograph to predict the success of nonoperative management is unknown.[5] In this study, the sensitivity, specificity, positive and negative likelihood ratios for waiting 4–8 hours were similar to waiting 24 hours before abdominal radiograph is carried out.[5,11] Thus, there appears to be no advantage of waiting more than 4–8 hours. In this trial, if the oral contrast agent is not detected in the colon after 8 hours the conservative management is considered a failure and operative management is warranted. Further, the intestine is decompressed using a nasogastric tube for a minimum of 12 hours before commencing the oral contrast agent study. Thus, in total, the nonoperative management trial takes at minimum 20 hours.

Because there are several exclusion criteria in this trial, the patients are selected, and the results will not be applicable to all patients presenting with an adhesive SBO. These exclusion criteria, however, should not be regarded as absolute contraindications for laparoscopic approach. Many of the exclusion criteria are relative contraindications (peritonitis, suspicion of other cause than adhesions, pregnancy, wide diffuse adhesions, peritoneal carcinosis) or predictors of failure of laparoscopic approach (endometriosis, earlier generalized peritonitis, over 3 open procedures, radiotherapy, vascular procedures).[12] Furthermore, earlier obesity surgery is an indication for laparoscopic approach, and these patients are excluded because we do not think it is ethical to randomize them for open approach. Some of the exclusion criteria (age >95 years, earlier abdominal surgery within 30 days, patient living in an institutional care, or prior hospital stay of over 1 week) were included to reduce the morbidity of the patients included in the study, as inclusion of a few of these patients in one of the arms would create a strong bias (i.e. the length of stay would be longer because of the morbidity of the patients, not because of the approach used).

The trial has been recruiting since summer 2013. Enrollment of the patients is estimated to last for 4–5 years and primary end-point results are estimated to be available in 2018.

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