Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066385
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-01
Brief Title:
Suture Techniques to Reduce the Incidence of Incisional Hernia LTFU STITCH Trial
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Suture Techniques to Reduce the Incidence of Incisional Hernia After Midline Laparotomy Long-Term Follow-Up of the STITCH Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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:
LTFU-STITCH
Brief Summary:
Rationale Incisional hernias IH are a frequent complication after abdominal surgery Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70 in high-risk patients after open surgery To investigate different fascia closure techniques in the prevention of IHs the STITCH trial NCT01132209 was designed The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy Patients were randomly assigned to the intervention group small bites 5 mm x 5 mm or the control group large bites 1 cm x 1 cm The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision
So far it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group
Objective The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial The secondary objectives are to measure quality of life QoL body image and cosmetic results and abdominal wall function through questionnaires and physical examination in those patients who are still alive
So far it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group
Objective The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial The secondary objectives are to measure quality of life QoL body image and cosmetic results and abdominal wall function through questionnaires and physical examination in those patients who are still alive
Detailed Description:
Rationale Incisional hernias IH are a frequent complication after abdominal surgery Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70 in high-risk patients after open surgery To investigate different fascia closure techniques in the prevention of IHs the STITCH trial NCT01132209 was designed a randomized controlled trial in which 560 patients were included between October 2009 and March 2012 The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy Patients were randomly assigned to the intervention group small bites 5 mm x 5 mm or the control group large bites 1 cm x 1 cm It showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision
So far it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group
Objective The primary objective of this study study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial The secondary objectives are to measure quality of life QoL body image and cosmetic results and abdominal wall function through questionnaires and physical examination in those patients who are still alive
Study design Assessment of long-term follow-up 10-13 years of a randomized controlled multicenter study based on retrospective review of patient files and relevant imaging of the entire trial population as well as questionnaires and physical and radiological examination of patient who are still alive
Study population Of the 560 included patients in the original STITCH trial 545 completed the 1-year follow-up
Intervention if applicable Not applicable Main study parametersendpoints The primary outcome measure is the 10-year midline incisional hernia rate The primary endpoint will be determined for the 545 patients of the original intention-to-treat population using Kaplan Meier analysis In patients who died during follow-up this will be evaluated by reviewing the available medical charts and radiological studies CT-scans of the abdomen will be evaluated by the study-team If CT imaging is not available documented findings during physical examination by the relevant medical specialist will be considered Patients being still alive with written informed consent to be contacted will be approached for their willingness to participate in this follow-up study and after consent we will reassess CT scans for an incisional hernia All patients who are still alive and want to participate in this study will be asked to visit the hospital once for physical examination and an ultrasound of the abdominal wall
Secondary outcome parameters include QoL and cosmetic outcome Patients still alive with consent for participation will be sent the following questionnaires MOS SF-36 and EQ-5D QoL Dresden Body Image Questionnaire body image Body Image Questionnaire cosmesis Hernia-Related Quality of Life Survey abdominal wall function Furthermore readmission and surgical intervention rates related to midline IH will be determined for the entire study population
Nature and extent of the burden and risks associated with participation benefit and group relatedness Undergoing an ultrasound physical examination and completing several questionnaires may be considered burdensome for the patient
So far it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group
Objective The primary objective of this study study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial The secondary objectives are to measure quality of life QoL body image and cosmetic results and abdominal wall function through questionnaires and physical examination in those patients who are still alive
Study design Assessment of long-term follow-up 10-13 years of a randomized controlled multicenter study based on retrospective review of patient files and relevant imaging of the entire trial population as well as questionnaires and physical and radiological examination of patient who are still alive
Study population Of the 560 included patients in the original STITCH trial 545 completed the 1-year follow-up
Intervention if applicable Not applicable Main study parametersendpoints The primary outcome measure is the 10-year midline incisional hernia rate The primary endpoint will be determined for the 545 patients of the original intention-to-treat population using Kaplan Meier analysis In patients who died during follow-up this will be evaluated by reviewing the available medical charts and radiological studies CT-scans of the abdomen will be evaluated by the study-team If CT imaging is not available documented findings during physical examination by the relevant medical specialist will be considered Patients being still alive with written informed consent to be contacted will be approached for their willingness to participate in this follow-up study and after consent we will reassess CT scans for an incisional hernia All patients who are still alive and want to participate in this study will be asked to visit the hospital once for physical examination and an ultrasound of the abdominal wall
Secondary outcome parameters include QoL and cosmetic outcome Patients still alive with consent for participation will be sent the following questionnaires MOS SF-36 and EQ-5D QoL Dresden Body Image Questionnaire body image Body Image Questionnaire cosmesis Hernia-Related Quality of Life Survey abdominal wall function Furthermore readmission and surgical intervention rates related to midline IH will be determined for the entire study population
Nature and extent of the burden and risks associated with participation benefit and group relatedness Undergoing an ultrasound physical examination and completing several questionnaires may be considered burdensome for the patient
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MEC 2022-0652 | REGISTRY | METC | None |
| IIS WC-2022-06 | OTHER_GRANT | None | None |