An observational study in Diverticular Diseases and Diverticulitis, sponsored by S.M. Misericordia Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by S.M. Misericordia Hospital · Observational
Over the last decade there has been a growing interest toward the application of robotic approach for diverticular disease. The evidence available on the literature showed that robotic approach, compared to the laparoscopic surgery, offers significant advantages in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease.
The investigators aimed at evaluating whether robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease by analyzing a one year multicenter prospective study.
Primary objective is to evaluate if robotic approach reduce the rate of conversion to open approach compared to laparoscopic surgery. Secondary objective is to assess difference between the two approaches in terms of rate of intraoperative complication, postoperative morbidities (according with Clavien and Dindo Classification), hospital stay and at one year follow up. Inclusion criteria are: elective colectomy for complicated or non-complicated diverticular disease performed with laparoscopic or robotic approach and age between 18 and 90 years. Exclusion criteria are non-elective colectomy (emergency resection), open procedure, diverticular resection performed during other procedure (i.e. colectomy for cancer). Data will be collected in one year from the start of the study.
Due to the lack of available evidence, it is impossible to draw definitive conclusions. With this study, the investigators hope to clarify the role of the robotic approach in the treatment of diverticular disease.
Background Over the past decade, there has been a growing interest in the use of robotic surgery for diverticular disease (DD). The evidence available in the literature is based on retrospective studies and two meta-analyses1,2. To date, the robotic approach offers significant advantages over laparoscopic surgery in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease.
The investigators aimed to evaluate whether elective robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease performing a prospective multicenter study.
Methods and Materials This is a multi-center, prospective, not-for-profit cohort study that will enroll patients undergoing elective or delayed urgent surgical treatment for left-sided colonic diverticular disease. The enrollment period will be one year, followed by one year of follow-up. The study will start in Juin 2023.
Data will be collected in a prospective database using an easy to fill out Google form, also available on mobile devices.
Several preoperative, intraoperative and postoperative outcomes will be analyzed.
OUTCOMES Pre-Operative
Intraoperative
Sample size The estimated sample sizes for the study using a proportion of 0.125 for Laparoscopic approach and a proportion of 0.074 for Robotic approach, and a risk of conversion rate OR=0.56 (IC95% 0.45-0.70), is at least 1450 patients (725 for the group - alpha = 0.0500, power = 0.9000, delta = 0.5600). MICE (Multivariate Imputation via Chained Equations) is the procedure used to impute missing data for explanatory variables. In this approach, instead of imputing all missing values with a single value (mean/median), the statistical information is derived from the median), it takes into account the statistical information derived from the distribution of the other variables. The missing values are considered as an outcome to be predicted. This allows to take into account the correct variability in the entire data set and to obtain estimates that are as unbiased as possible.
Statistical Analysis The quantitative variables included in the study are expressed as mean ± standard deviation, median and range (distance between maximum and minimum values), both at the overall level and by surgical approach. The qualitative (categorical) variables are presented as percentages and absolute values, both at a general level and divided by surgical approach. It will be evaluated, if necessary, to perform a propensity score matching procedure between the two approaches (Rob and Lap), using the nearest neighbor matching technique, without replacement. Demographics, pre-operative and intra-operative characteristics are used in the propensity score logistic regression models to minimize selection bias, by assembling a matched cohort in which confounding factors are balanced between the two groups. In the matched cohort bivariate analyses are performed to .compare the primary and secondary outcomes between the two groups.
The comparison between the quantitative variables of interest is performed by the two-tailed Student T-test (in case of heteroskedasticity of variances) or with nonparametric tests, such as the Mann-Whitney U test or theKruskal-Wallis test. The comparison between qualitative variables of interest is carried out to evaluate the association or not between them, through an extension of the chi-square test suitable for multicenter studies (the Cochran - Mantel - Haenszel test).
For the entire cohort multivariate logistic regression models are performed to test the effect of surgical approach on primary and secondary outcomes.
Ethics and dissemination The trial will be conducted in accordance with the Declaration of Helsinki and in compliance with the Good Clinical Practice, Principle E6 (R2). The study will be approved by the Ethics Committee of the coordinating center (Comitato Etico di Area Vasta Sud Est Dipartimento Politiche del Farmaco e Attività Farmaceutiche Segreteria Amministrativa) and then will be registered at ClinicalTrial.gov. Subsequently, all participating centers will receive approval to participate from the local institutional review board. Authorship for written publications will be confirmed for all participating investigators (2 investigators per center). Anonymized participant-level data sets will be made available upon reasonable upon reasonable request by contacting the principal investigator. Study results will be presented at international or national meetings and published in surgical journals.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's planned enrollment of 1,450 is above the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →S.M. Misericordia Hospital is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within Diverticulitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diverticular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with diverticular disease of the left colon with surgical indication.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with diverticular disease resected with a robotic approach.
Procedure: Robotic left colectomy
Patients with diverticular disease resected with a laparoscopic approach.
Procedure: Laparoscopic Left colectomy
Patients are treated with a laparoscopic approach as the standard of care for the treatment of left-sided colonic diverticular disease, depending on the experience of the surgeon or institution.
Patients are treated with a robotic approach as the standard of care for the treatment of left-sided colonic diverticular disease, depending on the experience of the surgeon or institution.
Conversion rate
The primary objective is to evaluate whether the robotic approach reduces the rate of conversion to open surgery compared to laparoscopic surgery.
Time frame: One year
Intra - operative complications
The first secondary outcome measure is to assess the difference between the two approaches in terms of intra-operative complications (e.g. bleeding, spleen injury, ureteral injury, bowel perforation)
Time frame: One year
Operative time
Evaluate the possible difference in terms of operative time (expressed in minutes) between the two groups, to assess whether the robotic approach has a longer operative time than the laparoscopic approach.
Time frame: One year
Complicated disease
Evaluate the difference between the two approaches in the number of complicated cases performed. For example, analyze whether one group performs more complicated diverticular disease (e.g., colonic stenosis, colorectal fistula, intraperitoneal abscess) than the other.
Time frame: One year
30 day Post - operative complications
Another secondary outcome measure is to assess the difference between the two groups in terms of post-operative complications (using the Clavien and Dindo classification).
Time frame: One year
30-day Post - operative re-operation
Evaluate the possible difference in term of rate of re-operation between the two groups within 30 day after surgery.
Time frame: One year
30-day Post - operative mortality
Evaluate the possible difference in term of rate of mortality between the two groups within 30 day after surgery.
Time frame: One year
Length of hospital stay
Evaluate the possible difference in term of length of hospital stay (expressed in day) between the two groups.
Time frame: One year
Time to return at work
Evaluate the possible difference in time to return to work (expressed in days from surgery) between the two groups.
Time frame: One year
One year follow up
Evaluate the possible difference in terms of disease recurrence or incisional hernia, between the two groups at one year after surgery.
Time frame: Two years
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Mar 2025, 21 months after the start.
Of 22 observational studies under Diverticulitis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 101. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
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S.M. Misericordia Hospital