Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543420
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy a Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single center single blind prospective randomized controlled trial Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 111 groups using lateral reconstruction posterior reconstruction or no reconstruction Patients were followed up regularly after surgery and clinical data were collected including daily use of urine pads ICIQ-SF score 24-hour urine leakage I-QoL score etc to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction thereby improving the quality of life of prostate cancer patients after surgery
Detailed Description:
This study is a single center single blind prospective randomized controlled trial Collect baseline data from enrolled patients Materials were randomly divided into experimental group A lateral reconstruction group experimental group B posterior reconstruction group and control group non reconstruction group in a 111 ratio using a computer-generated random number sequence
In the control group non reconstruction group no lateral or posterior reconstruction was performed after RARP surgery
In experimental group A lateral reconstruction group lateral reconstruction was performed after RARP surgery in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure
In experimental group B post reconstruction group post reconstruction was performed after RARP surgery
This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not
Preoperative collection of baseline data from patients includes age BMI history of abdominal surgery most recent PSA PI-RADS score prostate volume prostate puncture related data histological type number of positive needlespuncture needles Gleason score maximum tumor proportion PSMA PET-CT results neoadjuvant therapy regimen International Advisory Committee on Urinary Incontinence Questionnaire Brief ICIQ-SF score International Index of Erectile Function IIEF-5 score International Prostate Symptom Score IPSS score etc
Collect postoperative patient surgical data including ASA score surgical duration intraoperative blood loss etc hospitalization data including hospitalization duration hospitalization costs etc and pathological data including lesion diameter histological type Gleason score pathological staging positive surgical margin invasion of capsule invasion of seminal vesicle and adjacent tissues etc
Follow up visits were conducted on patients at 1 3 6 9 and 12 months postoperatively and relevant clinical data were collected including the number of urine pads used per day during follow-up ICIQ-SF score 24-hour urine leakage accurately measured by purchasing an electronic scale for patients perioperative and postoperative complications IIEF-5 score PSA and urinary incontinence quality of life questionnaire I-QOL score in order to evaluate the improvement effect of lateral reconstruction on urinary control and quality of life as well as the impact on complication incidence erectile function and tumor control The differences in the effects of lateral reconstruction and posterior reconstruction on urinary control recovery and quality of life improvement were compared
In the control group non reconstruction group no lateral or posterior reconstruction was performed after RARP surgery
In experimental group A lateral reconstruction group lateral reconstruction was performed after RARP surgery in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure
In experimental group B post reconstruction group post reconstruction was performed after RARP surgery
This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not
Preoperative collection of baseline data from patients includes age BMI history of abdominal surgery most recent PSA PI-RADS score prostate volume prostate puncture related data histological type number of positive needlespuncture needles Gleason score maximum tumor proportion PSMA PET-CT results neoadjuvant therapy regimen International Advisory Committee on Urinary Incontinence Questionnaire Brief ICIQ-SF score International Index of Erectile Function IIEF-5 score International Prostate Symptom Score IPSS score etc
Collect postoperative patient surgical data including ASA score surgical duration intraoperative blood loss etc hospitalization data including hospitalization duration hospitalization costs etc and pathological data including lesion diameter histological type Gleason score pathological staging positive surgical margin invasion of capsule invasion of seminal vesicle and adjacent tissues etc
Follow up visits were conducted on patients at 1 3 6 9 and 12 months postoperatively and relevant clinical data were collected including the number of urine pads used per day during follow-up ICIQ-SF score 24-hour urine leakage accurately measured by purchasing an electronic scale for patients perioperative and postoperative complications IIEF-5 score PSA and urinary incontinence quality of life questionnaire I-QOL score in order to evaluate the improvement effect of lateral reconstruction on urinary control and quality of life as well as the impact on complication incidence erectile function and tumor control The differences in the effects of lateral reconstruction and posterior reconstruction on urinary control recovery and quality of life improvement were compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None