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Study Title and Description

Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial.



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial.
Author van de Wall BJM., Stam MAW., Draaisma WA., Stellato R., Bemelman WA., Boermeester MA., Broeders IAMJ., Belgers EJ., Toorenvliet BR., Prins HA., Consten ECJ.
Country Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands.
Year 2017
Numbers Pubmed ID: 28404008

Secondary Publication Information
UI Title Author Country Year
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 HE., Consten ECJ., van der Palen J., van de Wall BJM., Broeders IAMJ., Bemelman WA., Lange JF., Boermeester MA., Draaisma WA. Department of Surgery, Meander Medisch Centrum, Amersfoort, The Netherlands. 2019
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DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial. van de Wall BJ., Draaisma WA., Consten EC., van der Graaf Y., Otten MH., de Wit GA., van Stel HF., Gerhards MF., Wiezer MJ., Cense HA., Stockmann HB., Leijtens JW., Zimmerman DD., Belgers E., van Wagensveld BA., Sonneveld ED., Prins HA., Coene PP., Karsten TM., Klaase JM., Statius Muller MG., Crolla RM., Broeders IA. Department of Surgery, Meander Medical Center Amersfoort, The Netherlands. 2010
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Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Elective surgery Laparoscopic surgery
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2 No intervention (non-placebo) Conservative management treatment: current daily practice
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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Study Design RCT
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RCT
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Country ... Specify Other ... Netherlands
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Funder Non-industry (fully)
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Study name DIRECT trial
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2010
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2014
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Inclusion criteria patients aged 18–75 years who presented to trial centres with either ongoing abdominal complaints or frequently recurring left-sided diverticulitis after a confirmed (ie, seen with CT scan, ultrasonography, or endoscopy) episode of diverticulitis.
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Exclusion criteria 1) previous elective or emergency surgery for acute sigmoid diverticulitis, OR 2) an absolute operation indication, OR 3) suspicion of a colorectal malignancy, OR 4) patients classified with a preoperative or postoperative risk of greater than III on the American Society of Anesthesiologists (ASA) classification
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... CT scan, ultrasonography, or endoscopy
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed The Hinchey classification was used to classify the primary episode of diverticulitis and was based on findings of either CT scan or ultrasonography
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery No intervention (non-placebo) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 28 Male 43
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Participant Age - Continuous data (in years) Median 54.1 Median 56.5
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IQR 44.6-62.1 IQR 48.3-63.2
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported 100 Not reported 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis Not reported Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Mean 3.1 Mean 4.1
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SD 1.0 SD 2.0
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Results & Comparisons


Results Data
Outcome: Mortality - All-cause (non-AE)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

N Analyzed 53 56
Counts 0 0
Percentage 0 0


5 years

N Analyzed 53 56
Counts 0 1
Percentage 0 1.8
Outcome: Recurrence of diverticulitis      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

N Analyzed 53 56
Counts 1 7
Percentage 1.9 12.5


5 years

N Analyzed 53 56
Mean 6 17
SD 11.3 30.4
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 38 30


5 years

Counts 103 127
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 18 23
N Analyzed 53 56
Percentage 34.0 41.1


5 years

Counts 37 45
N Analyzed 53 56
Percentage 69.8 80.4
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 4 2
N Analyzed 53 56
Percentage 7.5 3.6


5 years

Counts 0 2
N Analyzed 53 56
Percentage 0 3.6
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 0 1
N Analyzed 53 56
Percentage 0 1.8


5 years

Counts 2 1
N Analyzed 53 56
Percentage 3.8 1.8
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 1 0
N Analyzed 53 56
Percentage 1.9 0
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


6 months

Counts 7 0
N Analyzed 53 56
Percentage 13.2 0
P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


0 months

N Analyzed 53 56
Mean 92.6 92.2
SD 22.8 21.3


6 months

N Analyzed 53 56 0.0001
Mean 114.4 100.4
SD 22.3 22.7


1 years

N Analyzed 53 56
Mean 112.8 101.2
SD 23.3 25.3


5 years

N Analyzed 53 56 0.018
Mean 118.2 108.5
SD 21.0 20.0
P-Value P-Value P-Value P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


0 months

N Analyzed 53 56
Mean 63.3 69.3
SD 21.7 13.6




N Analyzed
Mean
SD


6 months

N Analyzed 53 56 <0.0001
Mean 23.9 48.3
SD 23.4 22.9


1 years

N Analyzed 53 56
Mean 30.5 47.5
SD 29.6 25.1


5 years

N Analyzed 53 56 0.011
Mean 28.6 44.1
SD 27.9 27.0
P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


0 months

N Analyzed 53 56
Mean 0.69 0.74
SD 0.21 0.20


6 months

N Analyzed 53 56 0.001
Mean 0.84 0.73
SD 0.20 0.19


1 years

N Analyzed 53 56
Mean 0.84 0.76
SD 0.15 0.24


5 years

N Analyzed 53 56 0.016
Mean 0.85 0.74
SD 0.18 0.21
P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


0 months

N Analyzed 53 56
Mean 37.0 36.9
SD 7.1 6.7


6 months

N Analyzed 53 56 0.016
Mean 43.5 39.5
SD 8.8 7.0


1 years

N Analyzed 53 56
Mean 46.7 42.4
SD 9.6 9.8


5 years

N Analyzed 53 56 0.030
Mean 47.6 42.6
SD 9.9 10.5
P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


0 months

N Analyzed 53 56
Mean 41.6 43.3
SD 14.5 9.5


6 months

N Analyzed 53 56 0.263
Mean 47.7 45.3
SD 12.4 10.3


1 years

N Analyzed 53 56
Mean 48.7 47.8
SD 10.2 9.6


5 years

N Analyzed 53 56 0.010
Mean 50.7 46.0
SD 9.4 9.2


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unsure
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Low
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No cross-over between two groups existed
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.