NCT03744143

Brief Summary

Multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

November 14, 2018

Last Update Submit

April 1, 2019

Conditions

Endometriosis

Keywords

Vaginal endometriosisDeep infiltrating endometriosis

Outcome Measures

Primary Outcomes (1)

  • Operative time

    To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time

    Intraoperative

Secondary Outcomes (4)

  • Complication rate

    Intraoperative

  • Evaluation of disease recurrence rate

    Up to 6 months after surgery; from date of surgery until the date of first clinical or trans-vaginal/abdominal ultrasound documented recurrence, assessed up to 6 months

  • Evaluation of dyspareunia recurrence rate

    Up to 6 months after surgery

  • Complication rate

    up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days

Study Arms (2)

Group A (vaginal technique)

OTHER

Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique

Procedure: Removal of vaginal endometriotic nodule

Group B (laparoscopic technique)

OTHER

Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.

Procedure: longitudinal sutureProcedure: transverse sutureProcedure: Removal of vaginal endometriotic nodule

Interventions

longitudinal suturePROCEDURE

Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a longitudinal suture

Group B (laparoscopic technique)
transverse suturePROCEDURE

Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a transverse suture

Group B (laparoscopic technique)
Removal of vaginal endometriotic nodulePROCEDURE

Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, or vaginal technique, isolating the nodule through the vagina.

Group A (vaginal technique)Group B (laparoscopic technique)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of vaginal endometriosis
  • Women undergoing surgical removal with complete endometriotic lesions involving the vagina
  • Informed consent for the processing of personal data for scientific purposes

You may not qualify if:

  • History of previous or ongoing neoplastic pathology
  • Patients committed to hysterectomy
  • Previous vaginal surgery
  • Not complete eradicating surgery
  • Vaginism-vulvodynia
  • Psychiatric disorders
  • Genital prolapse
  • Surgical menopause or spontaneous or pharmacological menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

January 3, 2019

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Locations

IT(2)