Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797585
Status:
TERMINATED
Last Update Posted:
2023-06-27
First Post:
2021-03-10
Brief Title:
Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Vaginal Hysterectomy and Laparoscopic Supracervical Hysterectomy at the Time of Sacrocolpopexy for the Treatment of Uterovaginal Prolapse
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ColoplastLSC
Brief Summary:
The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive laparoscopic sacrocolpopexy performed with concurrent vaginal hysterectomy versus laparoscopic supracervical hysterectomy The secondary objectives are to determine if there are differences in intraoperative adverse events and postoperative mesh-related complications and prolapse recurrence between the groups
Detailed Description:
Study Procedures
Study Identification and Recruitment Potential subjects will be identified by members of the Center for Urogynecology Pelvic Reconstructive Surgery at the Cleveland Clinic Main campus Hillcrest Hospital and Fairview Hospital Eligible patients who agree to participate will be provided written informed consent administered by the collaborators listed on this IRB
Randomization All subjects will be predetermined by their surgeon to undergo a laparoscopic sacrocolpopexy The participants will then be randomized to either concurrent vaginal hysterectomy or laparoscopic supracervical hysterectomy according to a computer-generated randomization schedule with the use of the SAS statistical software package SAS Institute Cary NC
Office Interventions All patients will be seen for a preoperative visit and then postoperatively at 6 12 and 24 months The 6 month visit will be standard of care the 12 month and 24 month visit will be a research visit At each visit a vaginal exam and a complete Pelvic Organ Prolapse Quantification POP-Q exam will be performed In addition patients will be asked to complete the Pelvic Floor Distress Inventory PFDI-20 Incontinence Severity Index ISI Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaire PISQ-12 and Patient Global Impression of Improvement PGII questionnaires at the pre-operative visit as well as the 6 12 and 24 month postoperative visits Completion of these questionnaires is the only additional assessment that is specific to participation in this study and is not usually included as part of the standard care of sacrocolpopexy It should take no more than 10-15 minutes to complete the questionnaires The study subjects will not be exposed to any additional risk by participating in this study except for the inconvenience of completing the questionnaires
Surgical Interventions The laparoscopic portions of the surgery will be performed using four ports an umbilical port for the laparoscope either 5 or 1012mm two ports either 5 8 or 1012 mm in the bilateral lower quadrants and one 5-mm port placed at the level of the umbilicus lateral to the rectus muscle on either side for retraction
If a supracervical hysterectomy is to be performed it will be done in a standard fashion A uterine manipulator will be placed inside of the uterus The round ligaments will be transected using cautery The fallopian tubes and ovaries will be left in situ or removed at the time of hysterectomy depending upon the preoperative decision made between the surgeon and patient The uterine arteries and cardinal ligaments will be cauterized laparoscopically The uterus will be amputated at the level of the internal cervical os and the endocervical canal will be cauterized The specimen will be extracted in a laparoscopic endocatch bag and removed through an extended incision at the umbilicus at the end of the case Dissection of the vagina anteriorly and posteriorly will be done laparoscopically with the use of an end-to-end anastomosis EEA sizer in the vagina Dissection of the presacral space will also be done laparoscopically Five to six 2-0 PDS sutures will be placed to secure the mesh to the anterior vagina as well as the posterior vagina for a total of 10-12 sutures on the vagina the arm of the mesh will be secured to the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures The Coloplast Restorelle Y mesh will be used for all cases The peritoneum will be closed with 0 or 2-0 vicryl sutures
If a vaginal hysterectomy is performed it will be done in a standard fashion using a traditional clamp and suture technique starting at the uterosacral ligaments and ending with the utero-ovarian ligaments The specimen will be extracted through the vagina Dissection of the vagina anteriorly and posteriorly will be done vaginally The mesh will be attached vaginally using five to six 2-0 PDS sutures on the anterior and posterior vagina for a total of 10-12 sutures on the vagina The Coloplast Restorelle Dual flat mesh will be used The vagina will then be closed in two layers using 0 or 2-0 vicryl suture Laparoscopic entrance will then be gained and set up will be done as described above The presacral space will be dissected laparoscopically and the mesh attached to the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures The peritoneum will be closed with 0 or 2-0 vicryl sutures
Study Identification and Recruitment Potential subjects will be identified by members of the Center for Urogynecology Pelvic Reconstructive Surgery at the Cleveland Clinic Main campus Hillcrest Hospital and Fairview Hospital Eligible patients who agree to participate will be provided written informed consent administered by the collaborators listed on this IRB
Randomization All subjects will be predetermined by their surgeon to undergo a laparoscopic sacrocolpopexy The participants will then be randomized to either concurrent vaginal hysterectomy or laparoscopic supracervical hysterectomy according to a computer-generated randomization schedule with the use of the SAS statistical software package SAS Institute Cary NC
Office Interventions All patients will be seen for a preoperative visit and then postoperatively at 6 12 and 24 months The 6 month visit will be standard of care the 12 month and 24 month visit will be a research visit At each visit a vaginal exam and a complete Pelvic Organ Prolapse Quantification POP-Q exam will be performed In addition patients will be asked to complete the Pelvic Floor Distress Inventory PFDI-20 Incontinence Severity Index ISI Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaire PISQ-12 and Patient Global Impression of Improvement PGII questionnaires at the pre-operative visit as well as the 6 12 and 24 month postoperative visits Completion of these questionnaires is the only additional assessment that is specific to participation in this study and is not usually included as part of the standard care of sacrocolpopexy It should take no more than 10-15 minutes to complete the questionnaires The study subjects will not be exposed to any additional risk by participating in this study except for the inconvenience of completing the questionnaires
Surgical Interventions The laparoscopic portions of the surgery will be performed using four ports an umbilical port for the laparoscope either 5 or 1012mm two ports either 5 8 or 1012 mm in the bilateral lower quadrants and one 5-mm port placed at the level of the umbilicus lateral to the rectus muscle on either side for retraction
If a supracervical hysterectomy is to be performed it will be done in a standard fashion A uterine manipulator will be placed inside of the uterus The round ligaments will be transected using cautery The fallopian tubes and ovaries will be left in situ or removed at the time of hysterectomy depending upon the preoperative decision made between the surgeon and patient The uterine arteries and cardinal ligaments will be cauterized laparoscopically The uterus will be amputated at the level of the internal cervical os and the endocervical canal will be cauterized The specimen will be extracted in a laparoscopic endocatch bag and removed through an extended incision at the umbilicus at the end of the case Dissection of the vagina anteriorly and posteriorly will be done laparoscopically with the use of an end-to-end anastomosis EEA sizer in the vagina Dissection of the presacral space will also be done laparoscopically Five to six 2-0 PDS sutures will be placed to secure the mesh to the anterior vagina as well as the posterior vagina for a total of 10-12 sutures on the vagina the arm of the mesh will be secured to the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures The Coloplast Restorelle Y mesh will be used for all cases The peritoneum will be closed with 0 or 2-0 vicryl sutures
If a vaginal hysterectomy is performed it will be done in a standard fashion using a traditional clamp and suture technique starting at the uterosacral ligaments and ending with the utero-ovarian ligaments The specimen will be extracted through the vagina Dissection of the vagina anteriorly and posteriorly will be done vaginally The mesh will be attached vaginally using five to six 2-0 PDS sutures on the anterior and posterior vagina for a total of 10-12 sutures on the vagina The Coloplast Restorelle Dual flat mesh will be used The vagina will then be closed in two layers using 0 or 2-0 vicryl suture Laparoscopic entrance will then be gained and set up will be done as described above The presacral space will be dissected laparoscopically and the mesh attached to the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures The peritoneum will be closed with 0 or 2-0 vicryl sutures
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