Study Preview
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? |
Primary Publication Information
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 | ||
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 |
Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | Elective surgery | Laparoscopic surgery | |
2 | No intervention (non-placebo) | Conservative management treatment: current daily practice |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
Study Design | RCT | ||
RCT | |||
Country ... Specify | Other ... | Netherlands | |
Funder | Non-industry (fully) | ||
Study name | DIRECT trial | ||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2010 | ||
2014 | |||
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. | ||
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 | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | CT scan, ultrasonography, or endoscopy | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
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 | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | No intervention (non-placebo) | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 28 | Male | 43 | |||
Participant Age - Continuous data (in years) | Median | 54.1 | Median | 56.5 | |||
IQR | 44.6-62.1 | IQR | 48.3-63.2 | ||||
Participant Age - Categorical data | No data entered. | ||||||
Participants with Un/Complicated Diverticulitis | Not reported | 100 | Not reported | 100 | |||
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 | |||||
KQ 4: Time Since Last Episode of Diverticulitis | Not reported | Not reported | |||||
Note/Comment about baseline characteristics | No data entered. | ||||||
Number of Prior Episodes of Diverticulitis (continuous) | Mean | 3.1 | Mean | 4.1 | |||
SD | 1.0 | SD | 2.0 |
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 |
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 |
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 |
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 |
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 |
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 | ||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | Unsure | ||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | High | ||
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 | ||
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | Low | ||
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | Low | ||
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | Low | ||
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | |||
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | |||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
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? | |||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | |||
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? | |||
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? | |||
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? | |||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | |||
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? | |||
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | |||
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | |||
Q11: Did the start and follow up calendar years coincide for most participants in the study? | |||
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | High | ||
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | No | cross-over between two groups existed | |
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
No quality rating data was found.