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Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis

5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial)

Bolkenstein, Hendrike E., MD*; Consten, Esther C. J., MD, PhD*; van der Palen, Job, MD, PhD; van de Wall, Bryan J. M., MD, PhD; Broeders, Ivo A. M. J., MD, PhD§; Bemelman, Willem A., MD, PhD; Lange, Johan F., MD, PhD||; Boermeester, Marja A., MD, PhD; Draaisma, Werner A., MD, PhD** Dutch Diverticular Disease (3D) Collaborative Study Group

doi: 10.1097/SLA.0000000000003033

Objective: The aim of this study was to establish whether surgical or conservative treatment leads to a higher quality of life (QoL) in patients with recurring diverticulitis and/or ongoing complaints.

Summary of Background Data: The 6 months’ results of the DIRECT trial, a randomized trial comparing elective sigmoidectomy with conservative management in patients with recurring diverticulitis (>2 episodes within 2 years) and/or ongoing complaints (>3 months) after an episode of diverticulitis, demonstrated a significantly higher QoL after elective sigmoidectomy. The aim of the present study was to evaluate QoL at 5-year follow-up.

Methods: From January 2010 to June 2014, 109 patients were randomized to either elective sigmoidectomy (N = 53) or conservative management (N = 56). In the present study, the primary outcome was QoL measured by the Gastrointestinal Quality of Life Index (GIQLI) at 5-year follow-up. Secondary outcome measures were SF-36 score, Visual Analogue Score (VAS) pain score, EuroQol-5D-3L (EQ-5D-3L) score, morbidity, mortality, perioperative complications, and long-term operative outcome.

Results: At 5-year follow-up, mean GIQLI score was significantly higher in the operative group [118.2 (SD 21.0)] than the conservative group [108.5 (SD 20.0)] with a mean difference of 9.7 (95% confidence interval 1.7–17.7). All secondary QoL outcome measures showed significantly better results in the operative group, with a higher SF-36 physical (P = 0.030) and mental score (P = 0.010), higher EQ5D score (P = 0.016), and a lower VAS pain score (P = 0.011). Twenty-six (46%) patients in the conservative group ultimately required surgery due to severe ongoing complaints. Of the operatively treated patients, 8 (11%) patients had anastomotic leakage and reinterventions were required in 11 (15%) patients.

Conclusion: Consistent with the short-term results of the DIRECT trial, elective sigmoidectomy resulted in a significantly increased QoL at 5-year follow-up compared with conservative management in patients with recurring diverticulitis and/or ongoing complaints. Surgeons should counsel these patients for elective sigmoidectomy weighing superior QoL, less pain, and lower risk of new recurrences against the complication risk of surgery.

*Department of Surgery, Meander Medisch Centrum, Amersfoort, The Netherlands

Department of Research Methodology, Measurement & Data Analysis, University of Twente, Enschede, The Netherlands

Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands

§Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands

Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands

||Department of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands

**Department of Surgery, Jeroen Bosch Hospital, Hertogenbosch, The Netherlands.

Reprints: Hendrike E. Bolkenstein, MD, Meander Medisch Centrum, 3800 BM Amersfoort, the Netherlands. E-mail:

HE Bolkenstein was involved in data acquisition, data analysis, interpretation of the data, and writing of the report. ECJ Consten, BJM van de Wall, IAMJ Broeders, WA Bemelman, JF Lange, MA Boermeester, and WA Draaisma were involved in the study design, data acquisition, interpretation of the data, and writing of the report. J van der Palen was involved in data analysis, interpretation of the data, and writing of the report. All authors gave final approval of the version to be published and agree to be accountable for all aspects of the work.

The DIRECT trial was funded by the Netherlands Organization for Health Research and Development (ZonMW: 171002201).

The authors declare no conflict of interest.

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