The diagnostic criteria for ESPBO-OP were: (1) intestinal obstruction that developed 1-4 wk postoperatively after initial recovery of postoperative ileus, as defined previously[16,17]; (2) typical operative history with extensive enterolysis or repeated laparotomy over a short period; (3) absence of severe colicky abdominal pain, but with obstipation, abdominal distension, nausea and vomiting; (4) palpation of a subincisional or whole abdominal mass on physical examination, with only mild or no tenderness on palpation, no peritoneal signs, and low-pitched or no bowel tones; and (5) low or absent air-fluid levels on upright abdominal film, edematous and thickened bowel wall with unclear borders on abdominal computed tomography (CT), and fluid-filled lumen with paucity of gas.

Exclusion criteria included: patients aged < 18 years; patients with terminal disease or presence of metastatic cancer; CT or X-ray film suggesting local adhesions, intussusceptions, volvulus, internal hernia, intra-abdominal abscesses, or hematoma; patients with suspicion of mechanical bowel obstruction, paralytic ileus, or idiopathic pseudo-obstruction; and patients with hypokalemia and retroperitoneal injury that may cause paralytic ileus. On previous laparotomy, all adhesions should have been freed and the possibility of mechanical obstruction, such as anastomotic stenosis or residual malignancy, excluded. All radiographs (X-ray and CT scan) were extrapolated by a specialist in gastrointestinal radiology.

Assignments were based on computer-generated randomizations that were kept in sealed, sequentially numbered envelopes until used. After a diagnosis of EPSBO-OP was made, patients were randomly assigned into one of the two groups: TPN group (T group) or TPN + dexamethasone + somatostatin group (TDS group). The study was approved by the ethics committee of the hospital, and all patients provided written informed consent before enrollment.

Nil by mouth and nasogastric tube were introduced for all patients. For patients in the control group (T group), a central venous catheter was placed on admission. After fluid resuscitation and correction of electrolyte abnormalities, patients were infused with TPN from all-in-one bags. The amount of non-protein calories (NPCs) was 20-25 kcal/kg per day or determined by indirect calorimetry. The NPCs consisted of 60%-70% carbohydrate, with the ratio of NPC: nitrogen = 120-140:1. Parenteral antibiotics were administered when leukocytosis was present. The amount of intravenous fluid was adjusted to maintain optimal hydration and sufficient urine output (> 1 L/d).

The duration of NG tube feeding depended on daily output. If daily NG output was < 200 mL for 2 d, the NG tube was clamped. The NG tube was removed if the patient was able to tolerate for 12 h after clamping. After patients resumed oral intake, gastrointestinal prokinetics (mosapride, 5 mg/8 h, Gasmotin; Dainippon Sumitomo Pharma Co. Ltd., Osaka, Japan) was given until discharge.

In the intervention group (TDS group), in addition to the treatment protocol in the control group, somatostatin (Stilamin; Merck-Serono S.A., Geneva, Switzerland) was given at 6 mg/d by continuous intravenous infusion. The criteria for stopping NG tube usage were similar to those for the T group, while somatostatin was stopped within 24 h after the patient defecated or passed gas. Dexamethasone sodium phosphate (5 mg/mL, Lukang Pharmaceuticals, Shandong, China) was used since the first day of treatment with an intravenous dosage of 5 mg/8 h for seven consecutive days, then 2.5 mg/12 h for 1 d, and stopped. If the patient defecated or passed gas in < 8 d after treatment, dexamethasone was withdrawn within 24 h after resolution of obstruction. During treatment, patients were carefully monitored for abdominal symptoms and systemic complications, such as cholestasis, central catheter infections, and systemic infections. Other complications, such as hypovolemia, electrolyte-fluid imbalance, and hyperglycemia, were corrected during treatment and not documented.

Indications for prompt surgery included suspicion for strangulation (continuous vs colicky pain, fever, tachycardia, peritoneal signs, and sustained leukocytosis), or clinical deterioration that implied failure of conservative management for > 3 mo.

The following parameters were recorded in each patient: age and sex; interval between symptom onset and the most recent laparotomy; clinical features including symptoms, presence or absence of fever, white blood cells, nutritional status, and comorbidity; procedures and duration of last operation; and time of previous laparotomy. Complete resolution of obstruction was established when symptoms and signs of obstruction subsided, normal flatus and defecation returned, and there was no relapse of obstructive symptoms after withdrawal of somatostatin. Then, liquid food or enteral nutrition was started. A semiliquid food was usually given 2 d later. Patients were discharged when intravenous fluid was stopped and semiliquid food was tolerated for 3 d.

The primary endpoints of the study were time to resolution of obstruction and length of hospital stay, and the secondary endpoints were daily NG output, NG tube placement duration, treatment-related complications, postoperative obstruction relapse, and patient satisfaction.

Sample size calculation was based on our previous data of historical comparison[18], which showed a mean 26.0 d for the intervention group and 30.3 d for the control group, with mean ± SD of 9.0 d. Approximately 35 patients in each group were needed to detect a difference in hospital stay with 80% power and a two-sided 5% significance level.

The patients were followed for ≥ 3 years after discharge. At each 6-mo visit, patients were given a questionnaire that was completed and returned by mail or they were contacted by telephone with the complete questions answered. Obstruction relapse was defined as abdominal pain with the halt of flatus, and nausea/vomiting, which needed further medical treatment and admission to hospital. At 1, 2 and 3 years, the degree of postoperative satisfaction was evaluated in every patient by using a unified scale (1-4) that indicated very unsatisfied, unsatisfied, satisfied, and very satisfied, respectively. Patient satisfaction was based on the core symptoms of the Gastrointestinal Quality of Life Index such as abdominal pain, feeling of abdominal distension, flatus and stool frequency, anorexia, fatigue, and nausea and vomiting[19]. The definition of “very satisfied” was the presence of none of the above-mentioned gastrointestinal symptoms in the past year; “satisfied” was occasional gastrointestinal symptoms; “unsatisfied” was several episodes of abdominal symptoms in the past year, and “very unsatisfied” was frequent abdominal symptoms.

Statistical analysis was performed by per-protocol analysis. Quantitative variables, presented as mean ± SD (range), were analyzed by Mann-Whitney U test or Student’s t test if appropriate. Quantitative variables, expressed as a number (percentage), were analyzed by Pearson’s χ² test or Fisher’s exact test. All analyses were performed with SPSS version 13.0 (SPSS, Chicago, IL, United States). P < 0.05 indicated statistical significance.

Between June 2002 and January 2009, 82 patients were diagnosed with EPSBO-OP in our department. Six patients were aged < 18 years and two declined to participate in the study, which left 74 patients enrolled in the study. Two patients were eventually confirmed to have mechanical obstruction and two had intra-abdominal abscesses or anastomotic fistulae and withdrew from the study. The dropout patients were eventually proven not to have EPSBO-OP, therefore, we used per-protocol analysis instead of intention-to-treat statistical analysis. Therefore, 70 cases were evaluated (34 in the T group and 36 in the TDS group) (Figure 1).

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Figure 1 Flow chart of patient inclusion and follow-up. TPN: Total parenteral nutrition; NG: Nasogastric; DM: Dexamethasone; SS: Somatostatin.

Patients’ demographic data and previous surgeries are listed in Tables 1 and 2. Fifteen patients (10 in the TDS group and 5 in the T group) had a history of malignancy but all underwent radical surgical resection. There were no significant differences between the two groups with respect to laboratory and clinical features at trial entry. The median onset of obstructive symptoms was postoperative day 9.4 ± 3.5 (range: 5-23 d).

Sixty-three patients underwent more than two operations before EPSBO-OP developed. At last surgery, extensive adhesiolysis (including intestinal splinting[20]) was performed in 54 (77.1%) of the operations; six (8.6%) received repeated laparotomy within 2 wk, and another six patients had diffuse peritonitis during last laparotomy. Although the mean number of operations (2.9 ± 1.3 vs 3.0 ± 1.0, P = 0.927) and type of operation were similar between the two groups, the operation time was shorter in the TDS group compared with the T group (4.1 ± 1.3 vs 4.8 ± 1.1 h, P = 0.041). Typical radiographic and intraoperative findings at the last operation are shown in Figures 2 and 3, respectively.

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Figure 2 Typical radiographic and intra-operative finding in the last operation. A: Typical upright radiograph of early postoperative small bowel obstruction with obliterative peritonitis after extensive adhesiolysis for abdominal cocoon, showing only mild air-fluid levels. No isolated small bowel loops were observed; B, C: Computed tomography scan reveals edematous small bowel filled-up with fluids. The border between the small bowel loops is not clear. No significant discrepancies in small bowel diameter and air-fluid levels were observed.

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Figure 3 Intraoperative photo of a patient who developed early postoperative small bowel obstruction with obliterative peritonitis. The 40-year-old male had a colostomy and patch-repair (arrow) of the abdominal defect after open abdomen due to trauma. He required closure of the stoma 6 months after colostomy. On operation, dense matted adhesions were found, especially beneath the patch, and full enterolysis resulted in extensive intestinal deserosalization (A). An intestinal splinting was performed (B). On postoperative day (POD) 10 the tube was removed, and he had a temporary return of bowel function but early postoperative small bowel obstruction with obliterative peritonitis on POD 15.

Treatment was successful for all patients in both groups. The mean length of hospital stay was 30.5 ± 10.9 (16-69) d. No patients withdrew because they needed surgery for strangulation or failure of conservative therapy. There were no deaths during treatment. In the TDS group, the mean duration of somatostatin usage was 23.5 ± 9.1 (14-53) d, while dexamethasone was used for 8 d in all patients.

As shown in Table 3, somatostatin and dexamethasone had a marked effect on the recovery of bowel function, as indicated by earlier passage of stool or gas (22.4 ± 9.1 vs 29.9 ± 10.1 d, P = 0.002). The length of hospital stay in the intervention group was shorter than in the control group (25.8 ± 9.9 vs 34.7 ± 11.2 d, P = 0.001).

The daily NG output and NG duration were evaluated as indicators of symptom control. The daily NG output was 583 ± 208 (150-1050) mL in the TDS group, which was significantly lower (P < 0.001) than that in the T group [922 ± 399 (400-1825) mL]. The need for NG tube use was also significantly shorter in the TDS group (16.7 ± 8.8 vs 27.7 ± 9.9 d, P < 0.001).

Treatment-related complications are shown in Table 4. The rate of overall complications was comparable in the TDS and T group (41.7% vs 38.2%, P = 0.770). Cholestasis, as revealed by increased bilirubin, AKP, γ-glutamyltransferase, or biliary sludge on ultrasonography, developed in 13 patients, and percutaneous transhepatic cholecystostomy (PTC) was performed in eight patients presenting with acalculous cholecystitis. The incidence of cholestasis and need for PTC were higher in the TDS group, but not significantly (P = 0.419 and 0.264, respectively). Infectious complications, including catheter-related sepsis, wound infection, and pneumonia, occurred in 15 patients. All blood culture-positive, catheter-related sepsis was cured with antibiotics. Statistical analysis revealed that there was no significant difference in infectious complications between the two groups (P = 0.677). Two patients had pneumothorax on catheter insertion.

Treatment with somatostatin and dexamethasone was well tolerated and did not cause any serious or clinical significant adverse reactions except that one patient in the intervention group complained of dry mouth.

Twelve patients were lost to follow-up (7 in the TDS group and 5 in the T group), and two patients in the T group died of relapse of primary colon cancer and gastric cancer after 12 and 18 mo of follow-up, respectively, while one in the TDS group died of cardiovascular disease (at 30 mo follow-up). Long-term follow-up data indicated that the rates of recurrence of obstruction at 1, 2 and 3 years postoperatively were similar between the two groups (Table 3). In addition, there was no significant difference in postoperative satisfaction at 1, 2 and 3 years between the two groups (Table 3).

Early postoperative small bowel obstruction due to obliterative peritonitis (EPSBO-OP) is a rare complication after abdominal surgery, especially extensive adhesiolysis and enterocutaneous fistula. Traditionally, the only treatment for these patients was total parenteral nutrition, nasogastric tube feeding, and observation. The time to the recovery of bowel function is often long and patients often suffer from low quality of life. Methods to promote resolution and control obstruction-related symptoms are lacking.

Somatostatin or its analogs and corticosteroids are effective and safe in patients with inoperative bowel obstruction due to peritoneal carcinomatosis or encapsulating peritoneal sclerosis. Therefore, their clinical role in the management of postoperative OP warrants further investigation.

Somatostatin and dexamethasone shorten the time to obstruction resolution and length of hospital stay, and decrease nasogastric output and duration of nasogastric tube usage. They do not increase treatment-related complications and relapse of obstruction.

This study revealed that somatostatin and dexamethasone are effective in promoting resolution and controlling symptoms in patients with EPSBO-OP.

This paper provides some useful information on the management of EPSBO-OP.