Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04671004
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-10
Brief Title:
The Concept of Parametria in the Treatment of Deep Infiltrating Endometriosis
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
The Concept of Parametria a Proposed Classification of Parametrectomy for the Treatment of Deep Infiltrating Endometriosis A Prospective Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Background Deep infiltrating endometriosis DIE is most commonly located at the uterosacral ligaments rectovaginal septum pararectal space and vesicouterine fold A nodule within the uterosacral ligaments ie involvement of the dorsal parametrium increases the complexity of surgical resection Parametrial involvement in DIE cases occurs in 25 of patients with severe endometriosis possibly with hypogastricsacral plexus or sciatic nerve involvement The bladder functional impairment after surgery for DIE involved the parametria may vary between the 65 to 328 Preservation of the hypogastric and pelvic splanchnic nerves represents the key aspect in pelvic surgery to prevent postoperative voiding disfunction Several techniques for the excision of DIE have been described but large prospective RCTs are lacking In particular a clear standardization of the parametrectomy for DIE is missing Systematic reviews on the surgical treatment of DIE demonstrated that it is impossible to compare the literature about the parametrectomy for DIE because to unclear definitions and lack of standardization We therefore believe it is necessary to propose a standardization of the definition of parametrectomy performed during procedures for DIE to allow a clear comparison in the future between scientific works on surgical treatment of DIE as already widely accepted in gynaecologic oncology with the classification of radical hysterectomy of Querleu-Morrow In particular we believe that the parametrectomy for DIE must be described based on its anatomical extension and focused on the concepts of nerve sparing dissection and vascular structures preservation to reduce the risk of complications due to ischemia ie ureter fistula
Rationale A standardized description of the procedure parametrectomy will allow the comparison between the different techniques in terms of functionality preservation of the pelvic sympathetic and parasympathetic neural pathway Therefore the availability of a clear classification able to define parametria involvement during surgery would be clinically relevant as they would allow to optimize counselling risk of neurological consequences and surgery planning
Type of the study Multicentric prospective observational study Primary objective To determinate the incidence of bladder functional impairment after surgery for DIE involved the parametria
Secondary objectives To classify the parametrectomy into a clear system of classification based on anatomical landmark and evaluate intrapostoperative complication to each classes of proposed parametrectomy
Sample size The sample size has been calculated on the basis of the primary objective in order to detect a proportion of bladder functional impairment of 30 with a confidence level of 95 and a margin of error of 9 a sample of N100 patients is required
Inclusion criteria - Patient scheduled for surgery for DIE
Confirmation of DIE needed of parametrectomy at laparoscopic surgery Exclusion criteria - Patients younger than 18 years and older than 50 years at time of operation
Refusal to answer the questionnaires
Absence of sexual activity
Diagnosis of multiple sclerosis
Pre-operative urodynamic diagnosis of neurogenic bladder dysfunction Statistical analysis The sample will be described in its clinical and demographic characteristics using descriptive statistics techniques Qualitative variables will be summarized as frequencies and percentages Quantitative variables will be presented as mean stddev Normality of data will be checked with Kolmogorov-Smirnov test The primary objective will be achieved calculating the incidence of bladder functional impairment after surgery The secondary objective will be achieved using descriptive statistics techniques already described
Rationale A standardized description of the procedure parametrectomy will allow the comparison between the different techniques in terms of functionality preservation of the pelvic sympathetic and parasympathetic neural pathway Therefore the availability of a clear classification able to define parametria involvement during surgery would be clinically relevant as they would allow to optimize counselling risk of neurological consequences and surgery planning
Type of the study Multicentric prospective observational study Primary objective To determinate the incidence of bladder functional impairment after surgery for DIE involved the parametria
Secondary objectives To classify the parametrectomy into a clear system of classification based on anatomical landmark and evaluate intrapostoperative complication to each classes of proposed parametrectomy
Sample size The sample size has been calculated on the basis of the primary objective in order to detect a proportion of bladder functional impairment of 30 with a confidence level of 95 and a margin of error of 9 a sample of N100 patients is required
Inclusion criteria - Patient scheduled for surgery for DIE
Confirmation of DIE needed of parametrectomy at laparoscopic surgery Exclusion criteria - Patients younger than 18 years and older than 50 years at time of operation
Refusal to answer the questionnaires
Absence of sexual activity
Diagnosis of multiple sclerosis
Pre-operative urodynamic diagnosis of neurogenic bladder dysfunction Statistical analysis The sample will be described in its clinical and demographic characteristics using descriptive statistics techniques Qualitative variables will be summarized as frequencies and percentages Quantitative variables will be presented as mean stddev Normality of data will be checked with Kolmogorov-Smirnov test The primary objective will be achieved calculating the incidence of bladder functional impairment after surgery The secondary objective will be achieved using descriptive statistics techniques already described
Detailed Description:
None
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