Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-19
First Post:
2023-04-11
Brief Title:
REsectability Small Bowel Obstruction LAParoscopic RESBOLAP Score Multicentric Data Registry
Sponsor:
San Salvatore Hospital AST Pesaro-Urbino
Organization:
San Salvatore Hospital AST Pesaro-Urbino
Study Overview
Official Title:
REsectability Small Bowel Obstruction LAParoscopic RESBOLAP Score Multicentric Data Registry
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
RESBOLAP
Brief Summary:
AIM OF THE STUDY The aim of the study is to develop a Resectability Laparoscopic Score as a helpful instrument during intraoperative decision-making in the setting of emergency laparoscopic surgery for small bowel obstruction SBO by analyzing a multicenter data registry
DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green ICG fluorescence angiography FA for doubts about bowel viability after the resolution of the obstructive mechanism the second phase of retrospective analysis to develop the Resectability Score
METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism with consequent intraoperative enrolment in the study Registry
The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality
It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3 representing the studys primary object
All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure
Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously The presence and pattern of arterial supply is tested and compared with that of healthy bowel Proper clearance of the dye was also appraised to verify adequate venous drainage Following the reversal of the underlying cause of the ischaemic injury and after generous irrigation with warm saline the involved bowel segment was further evaluated with FA after 10 min regardless of the return of visible peristalsis
Routine postoperative clinical judgment will be considered sufficient to check bowel vitality
The need for a second-look surgery and delayed resections will be recorded All centers could participate with a maximum of 3-4 members co-authorship Data will be recorded by a simple and brief online Case Report Form CRF on which upload also a photobrief video of the FA will be filled out by every participating center for each patient
A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study
DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green ICG fluorescence angiography FA for doubts about bowel viability after the resolution of the obstructive mechanism the second phase of retrospective analysis to develop the Resectability Score
METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism with consequent intraoperative enrolment in the study Registry
The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality
It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3 representing the studys primary object
All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure
Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously The presence and pattern of arterial supply is tested and compared with that of healthy bowel Proper clearance of the dye was also appraised to verify adequate venous drainage Following the reversal of the underlying cause of the ischaemic injury and after generous irrigation with warm saline the involved bowel segment was further evaluated with FA after 10 min regardless of the return of visible peristalsis
Routine postoperative clinical judgment will be considered sufficient to check bowel vitality
The need for a second-look surgery and delayed resections will be recorded All centers could participate with a maximum of 3-4 members co-authorship Data will be recorded by a simple and brief online Case Report Form CRF on which upload also a photobrief video of the FA will be filled out by every participating center for each patient
A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study
Detailed Description:
Albeit the role of laparoscopy in the treatment of acute small bowel obstruction SBO has grown significantly over the last decade the inability to obtain an adequate evaluation of compromised bowel segments has been considered as real limitation This is essentially due to a reduced field of view owing to intestinal distension the minimized haptic feedback obtained and limited bi-dimensional visualization As a consequence the presence of normal visual clues to irreversible vascular insufficiency is much reduced
Such signs include stable discoloration of the bowel wall absence of peristaltic movements and apparent mesenteric pulsation Intestinal perfusion and viability are largely assessed by means of the clinical eye However this method lacks objectivity and accuracy irrespective of a surgeons experience Routinely clinical judgment may be appropriate but the rate of conversion due to concerns regarding bowel viability can be high Where there are concerns for intestinal ischaemic injury without absolute indications to bowel resection areas of mural gangrene or bowel necrosis with perforation intestinal compromise can be appraised by real-time fluorescent analysis of the vascular supply
Some authors reported their experience on the use of the ICG fluorescent angiography FA to assess bowel viability during laparoscopic approach in emergency surgery for SBO with promising results Nowadays an important drawback of qualitative intraoperative assessment of bowel compromise with FA is the interpretation and definition of the boundaries between bowel viability and irreversible ischemia in order to avoid or reduce the rate of delayed bowel necrosis and perforation An instrument more objective as possible to help surgeons during the intraoperative decision-making is lacking A resectability score could be resolutive but a large amount of data from a multicentric data registry is needed
Finally when the registry will be completed a logistic regression analysis will be used to identify independent predictive factors of bowel resectability by calculation of odds ratios and its 95 CI based on delayed bowel resection rate too Significant continuous variables will be transformed into categorical variables using receiver operating characteristic ROC curves The sample size required for the development of the Score was determined according to previous reports The number of unnecessary bowel resections has been estimated around 46 Two studies on ICG-fluorescence angiography use during laparoscopic surgery for SBO reported 286 of resection rate The investigators adopted this degree of difference as the maximum error tolerance of 174 Considering a power of 09 a significance level of 005 a 95 CI with its two sides of 0112 and 046 the required sample size will be of 26 subjects that will undergo to bowel resection that must be associated with other 26 subjects with no bowel resection and other 26 will undergo delayed bowel resection for a total of 78 patients According to this sample size the score will have a sensitivity of 028 a specificity of 073 a positive predictive value of 022 a negative predictive value of 073 and a precision value of 039
The optimal cut-off point with the highest sum of sensitivity and specificity will be chosen for each variable also the overall predictive value of the Score will be assessed Finally a score will be developed by assigning coefficient points to each variable
Such signs include stable discoloration of the bowel wall absence of peristaltic movements and apparent mesenteric pulsation Intestinal perfusion and viability are largely assessed by means of the clinical eye However this method lacks objectivity and accuracy irrespective of a surgeons experience Routinely clinical judgment may be appropriate but the rate of conversion due to concerns regarding bowel viability can be high Where there are concerns for intestinal ischaemic injury without absolute indications to bowel resection areas of mural gangrene or bowel necrosis with perforation intestinal compromise can be appraised by real-time fluorescent analysis of the vascular supply
Some authors reported their experience on the use of the ICG fluorescent angiography FA to assess bowel viability during laparoscopic approach in emergency surgery for SBO with promising results Nowadays an important drawback of qualitative intraoperative assessment of bowel compromise with FA is the interpretation and definition of the boundaries between bowel viability and irreversible ischemia in order to avoid or reduce the rate of delayed bowel necrosis and perforation An instrument more objective as possible to help surgeons during the intraoperative decision-making is lacking A resectability score could be resolutive but a large amount of data from a multicentric data registry is needed
Finally when the registry will be completed a logistic regression analysis will be used to identify independent predictive factors of bowel resectability by calculation of odds ratios and its 95 CI based on delayed bowel resection rate too Significant continuous variables will be transformed into categorical variables using receiver operating characteristic ROC curves The sample size required for the development of the Score was determined according to previous reports The number of unnecessary bowel resections has been estimated around 46 Two studies on ICG-fluorescence angiography use during laparoscopic surgery for SBO reported 286 of resection rate The investigators adopted this degree of difference as the maximum error tolerance of 174 Considering a power of 09 a significance level of 005 a 95 CI with its two sides of 0112 and 046 the required sample size will be of 26 subjects that will undergo to bowel resection that must be associated with other 26 subjects with no bowel resection and other 26 will undergo delayed bowel resection for a total of 78 patients According to this sample size the score will have a sensitivity of 028 a specificity of 073 a positive predictive value of 022 a negative predictive value of 073 and a precision value of 039
The optimal cut-off point with the highest sum of sensitivity and specificity will be chosen for each variable also the overall predictive value of the Score will be assessed Finally a score will be developed by assigning coefficient points to each variable
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