Surgery May Improve Quality of Life in Unrelenting Diverticulitis

Caroline Helwick

May 29, 2015

WASHINGTON, DC — For patients with persistent or recurring diverticulitis, elective resection improves quality of life more than conservative management of the disease, results from the DIRECT study suggest.

"Elective resection is significantly better in terms of quality of life, despite surgery-related risks," said Marguerite Stam, MD, from the Meander Medical Center in Amersfoort, the Netherlands.

Approximately 30% of diverticulitis patients remain symptomatic after an initial episode, and 30% experience recurrence, she explained. Previous studies have suggested that surgery offers advantages to these patients, but many surgeons are reluctant to operate because of the potential for complications.

"We believe our results are imperative for counseling these patients," said Dr Stam, who reported the study findings during a late-breaking session here at Digestive Disease Week 2015.

The multicenter randomized controlled DIRECT trial compared a conservative approach with a surgical option in patients presenting with either persistent abdominal complaints for at least 3 months or at least 3 recurring episodes of diverticulitis in the 2 years after a confirmed episode of diverticulitis.

DIRECT Trial

The 109 patients from 27 different hospitals were randomized to either laparoscopic elective resection or conservative management, which primarily consisted of pain medication and stool softeners.

Mean age was 54 years, and 64% of the participants were women.

Of the 53 patients in the resection group, 47 underwent surgery and six switched over to conservative treatment. Of the 56 patients in the conservative-management group, 43 continued on with the planned approach and 13 requested surgery.

Baseline demographic and disease characteristics were similar in the two groups, and more than half the patients in each group had experienced symptoms for more than 1 year.

The primary end point of quality-of-life score at 6 months, determined with the Gastro-Intestinal Quality of Life Index in conjunction with other validated quality-of-life instruments, was significantly better with resection than with conservative management (114.4 vs 100.4; P = .0001).

On the Short-Form Health Survey (SF-36), physical measure scores were significantly higher with surgery than with conservative management (P = .0106), but mental health scores were similar.

In addition, scores were significantly higher with surgery on the 100-point EuroQOL 5D (EQ-5D6), another quality-of-life measure (80 vs 70; P = .0013), as were pain scores on a visual analog scale (20 vs 42; P < .0001).

The 13 patients in the conservative-management group who "demanded surgery" did so a mean of 2.5 months after randomization. Of these, five had recurrences and eight had ongoing complaints. The decision to perform surgery on these patients was made by a multidisciplinary team. There were no differences between these patients and others in terms of quality of life at baseline, so they were included in the intent-to-treat analysis.

In 87% of the patients, surgery was laparoscopic; in 13%, an open approach was used. Three patients had stoma at 6 months, seven patients experienced anastomic leakage, five patients had surgical-site infections, and two had cardiovascular or pulmonary complications.

There were fewer recurrences with surgery than with conservative management (1 vs 7), and no deaths related to treatment.

A Question of Bias

This study probably suffered from bias, said Ronald Koretz, MD, from the David Geffen School of Medicine at the University of California, Los Angeles.

"We view randomized controlled trials as the gold standard for treatment comparisons, but they are not all constructed equally. Some have subtle biases, which can make the results look better or hide things that are worse," Dr Koretz told Medscape Medical News.

"The researchers measured subjective outcomes — pain and quality of life. They said they used a validated scoring system, but the fact that it's validated doesn't matter. The patient's answer is still subjective," he explained. "They would have come into the study with a preconceived notion of which treatment would be better or worse."

However, "it is almost impossible to do this kind of trial in a blinded fashion," he acknowledged.

The difference in quality-of-life scores on the Gastro-Intestinal Quality of Life Index was "not huge," he pointed out.

"The data do not convince me that quality of life gets better, whether you have the surgery or not," Dr Koretz said.

Dr Stam and Dr Koretz have disclosed no relevant financial relationships.

Digestive Disease Week (DDW) 2015: Abstract 901c. Presented May 19, 2015.

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