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

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?

Comments (
0
) |
Post/View

Primary Publication Information

Comments (
0
) |
Post/View

Title	Data
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	Comments ( 0 ) \| Post/View
	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	Comments ( 0 ) \| Post/View

Extraction Form: Extraction Form for KQs 2 and 4

Arms

Number	Title	Description	Comments
1	Elective surgery	Laparoscopic surgery	Comments ( 0 ) \| Post/View
2	No intervention (non-placebo)	Conservative management treatment: current daily practice	Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Specific KQ	KQ 4c: Surgery (recur prev)		Comments ( 0 ) \| Post/View
	KQ 4c: Surgery (recur prev)		Comments ( 0 ) \| Post/View
	KQ 4c: Surgery (recur prev)		Comments ( 0 ) \| Post/View
Study Design	RCT		Comments ( 0 ) \| Post/View
Study Design	RCT		Comments ( 0 ) \| Post/View
Country ... Specify	Other ...	Netherlands	Comments ( 0 ) \| Post/View
Funder	Non-industry (fully)		Comments ( 0 ) \| Post/View
Study name	DIRECT trial		Comments ( 0 ) \| Post/View
Associated articles			Comments ( 0 ) \| Post/View
ClinicalTrials.gov identifier			Comments ( 0 ) \| Post/View
Start and end years of the Study	2010		Comments ( 0 ) \| Post/View
Start and end years of the Study	2014		Comments ( 0 ) \| Post/View
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.		Comments ( 0 ) \| Post/View
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		Comments ( 0 ) \| Post/View
Specific population?	No (all comers)		Comments ( 0 ) \| Post/View
Was diverticulitis diagnosed with CT? ...	Unclear/Multiple methods (explain) ...	CT scan, ultrasonography, or endoscopy	Comments ( 0 ) \| Post/View
If NRCS, what analytic method was used to account for differences between study arms?			Comments ( 0 ) \| Post/View
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		Comments ( 0 ) \| Post/View
Note/Comment about Design (or overall study)			Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	Elective surgery		No intervention (non-placebo)		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
Participant race/ethnicity characteristics	Male	28	Male	43			Comments ( 0 ) \| Post/View
Participant Age - Continuous data (in years)	Median	54.1	Median	56.5			Comments ( 0 ) \| Post/View
Participant Age - Continuous data (in years)	IQR	44.6-62.1	IQR	48.3-63.2			Comments ( 0 ) \| Post/View
Participant Age - Categorical data	No data entered.
Participants with Un/Complicated Diverticulitis	Not reported	100	Not reported	100			Comments ( 0 ) \| Post/View
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				Comments ( 0 ) \| Post/View
KQ 4: Time Since Last Episode of Diverticulitis	Not reported		Not reported				Comments ( 0 ) \| Post/View
Note/Comment about baseline characteristics	No data entered.
Number of Prior Episodes of Diverticulitis (continuous)	Mean	3.1	Mean	4.1			Comments ( 0 ) \| Post/View
Number of Prior Episodes of Diverticulitis (continuous)	SD	1.0	SD	2.0			Comments ( 0 ) \| Post/View

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		Comments ( 0 ) \| Post/View
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment	Unsure		Comments ( 0 ) \| Post/View
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study	High		Comments ( 0 ) \| Post/View
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		Comments ( 0 ) \| Post/View
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.	Low		Comments ( 0 ) \| Post/View
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data	Low		Comments ( 0 ) \| Post/View
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting	Low		Comments ( 0 ) \| Post/View
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.			Comments ( 0 ) \| Post/View
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?			Comments ( 0 ) \| Post/View
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?			Comments ( 0 ) \| Post/View
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?			Comments ( 0 ) \| Post/View
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?			Comments ( 0 ) \| Post/View
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING			Comments ( 0 ) \| Post/View
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?			Comments ( 0 ) \| Post/View
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?			Comments ( 0 ) \| Post/View
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?			Comments ( 0 ) \| Post/View
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?			Comments ( 0 ) \| Post/View
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?			Comments ( 0 ) \| Post/View
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY			Comments ( 0 ) \| Post/View
Q2: Did the study divide the follow up time of each individual participant into the different interventions?			Comments ( 0 ) \| Post/View
Q11: Did the start and follow up calendar years coincide for most participants in the study?			Comments ( 0 ) \| Post/View
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.	High		Comments ( 0 ) \| Post/View
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?	Yes		Comments ( 0 ) \| Post/View
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?	No	cross-over between two groups existed	Comments ( 0 ) \| Post/View
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?	Yes		Comments ( 0 ) \| Post/View

Quality Rating

No quality rating data was found.

Select a Topic:
Your Feedback:

Study Preview

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

Exit Disclaimer