Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829343
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-04-11
Brief Title:
RObotic Versus LAparoscopic Colectomy for DIverticulitis
Sponsor:
SM Misericordia Hospital
Organization:
SM Misericordia Hospital
Study Overview
Official Title:
RObotic vs LAparoscopic Colectomy for DIverticulitis A Multicenter Observational Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROLADI
Brief Summary:
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 ie 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
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 ie 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
Detailed Description:
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-analyses12 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
Demographic Outcomes Age gender body mass index BMI American Society of Anesthesiologists ASA Charlson Comorbidity Index CSI httpswwwmdcalccomcalc3917charlson-comorbidity-index-cci
Indications for surgery
Complicated DD colonic stenosis abscess fistula others
Recurrent DD multiple episodes of diverticulitis affecting quality of life
Planned vascular ligation inferior mesenteric artery vs sigmoid arteries
Preoperative bowel preparation
Indication for minimally invasive approach pursued Why Rob vs Lap
Intraoperative
Surgical approach laparoscopic or robotic
Intraoperative findings sigmoid stenosis stricture adhesion fistula
Intraoperative complications specify types
Conversion to open approach
Operative times
Effective vessel ligation
Splenic flexure mobilization
Type of colon resection sigmoidectomy left colectomy anterior rectal resection Hartmann procedure
Stoma ileostomy vs colostomy
Associated procedures
Specimen extraction midline off midline suprapubic or natural orifice Postoperative
30-day postoperative complications Clavien-Dindo classification
30-day reoperation
30-day readmission
Length of stay LOS
Time to return to work days
30 days - Mortality
One-year follow-up
Sample size The estimated sample sizes for the study using a proportion of 0125 for Laparoscopic approach and a proportion of 0074 for Robotic approach and a risk of conversion rate OR056 IC95 045-070 is at least 1450 patients 725 for the group - alpha 00500 power 09000 delta 05600 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 meanmedian 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 ClinicalTrialgov 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
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
Demographic Outcomes Age gender body mass index BMI American Society of Anesthesiologists ASA Charlson Comorbidity Index CSI httpswwwmdcalccomcalc3917charlson-comorbidity-index-cci
Indications for surgery
Complicated DD colonic stenosis abscess fistula others
Recurrent DD multiple episodes of diverticulitis affecting quality of life
Planned vascular ligation inferior mesenteric artery vs sigmoid arteries
Preoperative bowel preparation
Indication for minimally invasive approach pursued Why Rob vs Lap
Intraoperative
Surgical approach laparoscopic or robotic
Intraoperative findings sigmoid stenosis stricture adhesion fistula
Intraoperative complications specify types
Conversion to open approach
Operative times
Effective vessel ligation
Splenic flexure mobilization
Type of colon resection sigmoidectomy left colectomy anterior rectal resection Hartmann procedure
Stoma ileostomy vs colostomy
Associated procedures
Specimen extraction midline off midline suprapubic or natural orifice Postoperative
30-day postoperative complications Clavien-Dindo classification
30-day reoperation
30-day readmission
Length of stay LOS
Time to return to work days
30 days - Mortality
One-year follow-up
Sample size The estimated sample sizes for the study using a proportion of 0125 for Laparoscopic approach and a proportion of 0074 for Robotic approach and a risk of conversion rate OR056 IC95 045-070 is at least 1450 patients 725 for the group - alpha 00500 power 09000 delta 05600 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 meanmedian 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 ClinicalTrialgov 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None