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Clin Colon Rectal Surg. 2006 November; 19(4): 247–250.
PMCID: PMC2780115
Reoperative Surgery
Guest Editor Michael J. Stamos M.D.

Reoperative Surgery: What Can We Learn from a Large Randomized Prospective Trial?

ABSTRACT

Several recent large prospective trials and surveys of colon and rectal surgery patients have been conducted. Reviewing these studies can provide insight into current colorectal surgery practices.

Keywords: Prospective trials, colon and rectal surgery practice

Several recent large prospective trials and surveys of colon and rectal surgery patients have been conducted. Reviewing these studies can provide insight into current colorectal surgery practices.

METHODS

A PubMed search of large prospective trials or surveys of colorectal patients for the previous 5 years was performed. Studies that focused on one operative procedure such as restorative proctocolectomies or laparoscopy were eliminated. Each of the studies reviewed can provide a perspective on colorectal surgery practice, but each has limitations related to selection of patients and methods of data collection.

The Seprafilm® Outcome Study1 was a large, prospective, randomized controlled trial that looked at the effect of an antiadhesive product (Seprafilm®) in preventing small bowel obstruction (SBO). Inclusion criteria included patients undergoing large bowel resection or adhesiolysis for SBO. Cancer patients were excluded. The study was conducted at 22 centers, and 83 surgeons were involved. Patients were randomly allocated to receive Seprafilm® to adhesiogenic areas in the abdomen or nothing (control) at the completion of the study. Patients' demographics and intraoperative information provide an accurate summary or “snapshot” of the colorectal surgery practice at many of the busiest colorectal surgery centers. Patients were followed up for a mean of 3.5 years (range 2 to 5 years) to assess the safety and long-term clinical benefit of Seprafilm®, specifically the incidence and types of subsequent bowel obstruction.

The Opening Time study2 was a prospective consecutive case series from 11 colorectal surgeons at three referral centers (Ochsner Clinic, Washington University in St Louis, and Cleveland Clinic Florida). The study evaluated the differences in opening time between patients with and without previous abdominal operations. Opening time was defined to start at skin incision and end when the surgeon's usual abdominal retractor was placed.

The Adhesiotomy Study3 was a retrospective review of reoperative patients to evaluate risk factors for inadvertent enterotomy. Records of consecutive patients who underwent abdominal reoperation at which adhesions were divided at a large referral hospital in the Netherlands were reviewed for preoperative and perioperative data. The retrospective nature of the data collection limits its value.

The COST Study4 was a prospective randomized controlled noninferiority trial from 48 institutions of patients with adenocarcinoma of the colon to compare open or laparoscopy-assisted colectomy. Surgeons participating in the study had their laparoscopic techniques evaluated by videotape. Patients were followed up a median of 4.4 years to assess time to tumor recurrence. The study was limited to patients with cancer, those willing to participate in such a study, and those thought to be candidates for either a laparoscopic or open procedure.

The Care Survey Study5 was a prospective survey of postoperative care in the United States and Europe. Data from U.S. patients (39 hospitals) undergoing elective abdominal operations were used for this review article. Emergency operations as well as patients with inflammatory bowel disease or stoma were excluded. Details of perioperative care and postoperative recovery were recorded to assess practice patterns that might improve recovery and reduce complications. The retrospective data collection limits its accuracy.

PATIENTS' DEMOGRAPHICS

Patients' demographics from each of the selected studies are summarized in Table Table1.1. In these studies, the mean ages varied from 45 to 70 years with a range of 18 to 96 years. Female patients constituted 46 to 66% of patients and a large percentage of patients had previous abdominopelvic surgery (43 to 100%). The disease processes and operations performed varied with the inclusion and exclusion criteria of each study. Comorbid conditions were common.

Table 1
Patients' Demographics

OPERATIVE ASPECTS

The types of cases performed also vary with inclusion and exclusion criteria of the studies. Adhesions clearly represent a major problem. They add additional time, cost, and morbidity to operative cases.2,3 Previous studies have demonstrated that Seprafilm® is effective in reducing adhesions6 Adhesions lengthen operations by increasing the time required to open an abdomen and the time required to divide the adhesions (Table 2). In the Opening Time study by Beck and colleagues, adhesions increased the opening time by an average of 16 minutes. Another study by Coleman and colleagues found a median increase in “incision time” of 5 minutes and an additional 15 minutes to divide adhesions if patients had previous surgery.7 In the Seprafilm Outcome study, adhesiolysis added 25.2 minutes. If operating room time has an estimated cost of $30 per minute, adhesions add $480 to $756 to each case.

Table 2
Operative Parameters

Enterotomies are another major intraoperative consequence or complication of adhesions. They occur in 8 to 19% of patients with adhesions.3,8 In addition to lengthening operating room time and increasing the stress on the surgeon, enterotomies result in significantly more complications (leaks, fistulas, sepsis, etc.), higher use of intensive care units, and longer hospital stays.4,9

As expected, incision length was greater in the open cases than in the laparoscopic cases, but there is wide variability and overlap. The open procedures averaged over 2 hours in duration, but as multiple studies have shown that open procedures are faster than laparoscopic cases. The incidence of cases that are performed with laparoscopic technique is difficult to document accurately. Most current estimates suggest that 15 to 20% of cases are laparoscopy assisted.

POSTOPERATIVE ASPECTS AND OUTCOMES

Several outcomes were evaluated in the reviewed articles (Table 3). The Seprafilm Outcome study demonstrated that Seprafilm® was safe with respect to abdominal abscess, pelvic abscess, and pulmonary embolism in patients undergoing abdominopelvic surgery.7 Foreign body reaction was not reported for any patient. However, wrapping the suture or staple line of a fresh bowel anastomosis or enterotomy repair with Seprafilm® was discouraged, as the data suggest that this practice might increase the risk of sequelae associated with anastomotic leak.7 This study revealed a surprisingly low incidence of overall and adhesive SBO after intestinal resection and anastomosis (12%). There was no significant difference between treatment and control groups in the overall rate of SBO. However, Seprafilm® adhesion barrier did reduce adhesive SBO (1.8 versus 3.4%, p < 0.05) and was the only factor that predicted this outcome. The clinical relevance of this reduction along with the advantages and disadvantages of adhesive prevention products must be individually determined. Unfortunately, a single adhesion can cause an SBO and a gross reduction of adhesions does not eliminate that possibility. Patients who have a high likelihood of recurrence of disease requiring operation (e.g., Crohn's disease) or develop functional problems after major procedures (ileoanal pouch procedures) that require reoperation will benefit from the use of antiadhesive therapy for the previously mentioned reasons. Although minimally invasive procedures may produce less adhesions than traditional open cases, as discussed in other articles in this issue, patients undergoing laparoscopic procedures do produce adhesions and experience SBOs. Each surgeon must weigh the value of these advantages against the cost of the antiadhesive product.

Table 3
Outcome Measures

Length of hospital stay is dependent on several factors. These include patient-related and cultural factors as well as postoperative management. The mean reported length of stay varied from 5 to 10 days in the reviewed studies, and a Medicare data review documented an average postoperative stay of 10 days. Perioperative care measures that have been shown to reduce postoperative stay include avoidance of nasogastric tubes and drains, early feeding and ambulation, pain management, and minimally invasive techniques.10,11,12,13,14 Many of these activities have been put together into “care paths” or “fast track” programs. The survey by Kehlet and Dahl suggests that few of these measures have yet gained widespread acceptance outside major training institutions.11

Mortality was low in the mostly elective cases reviewed, but morbidity remains significant (20 to 38%). Morbidity is higher in reoperative surgery, and many of the articles in this issue address this aspect.

SUMMARY

Review of large series of colon and rectal surgery patients provides insight into current practice patterns. Colorectal surgeons operate on challenging patients with overall good results.

DISCLOSURE

The author of this article was the author of several articles reviewed and has been a consultant for Genzyme.

REFERENCES

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Articles from Clinics in Colon and Rectal Surgery are provided here courtesy of Thieme Medical Publishers