Bryan J M van de Wall1, Marguerite A W Stam1, Werner A Draaisma1, R Stellato2, Willem A Bemelman3, Marja A Boermeester3, Ivo A M J Broeders1, Eric J Belgers4, Boudewijn R Toorenvliet5, Hubert A Prins6, Esther C J Consten7. 1. Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands. 2. Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands. 3. Department of Surgery, Academic Medical Centre, Amsterdam, Netherlands. 4. Department of Surgery, Atrium Medical Centre, Heerlen, Netherlands. 5. Department of Surgery, Ikazia Hospital, Rotterdam, Netherlands. 6. Department of Surgery, Jeroen Bosch Hospital, Den Bosch, Netherlands. 7. Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands. Electronic address: ecj.consten@meandermc.nl.
Abstract
BACKGROUND:Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with eitherconservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. METHODS: We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18-75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. FINDINGS: Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months' follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114·4 [SD 22·3]) than conservative management (100·4 [22·7]; mean difference 14·2, 95% CI 7·2-21·1, p<0·0001). 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs 23 [40%] of 57 patients in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. INTERPRETATION:Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.
RCT Entities:
BACKGROUND:Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. METHODS: We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18-75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. FINDINGS: Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months' follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114·4 [SD 22·3]) than conservative management (100·4 [22·7]; mean difference 14·2, 95% CI 7·2-21·1, p<0·0001). 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs 23 [40%] of 57 patients in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. INTERPRETATION: Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.
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