Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy (Coloplast LSC)

A Prospective Randomized Trial Comparing Vaginal Hysterectomy and Laparoscopic Supracervical Hysterectomy at the Time of Sacrocolpopexy for the Treatment of Uterovaginal Prolapse

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Hysterectomy; Laparoscopic Supracervical Hysterectomy
• Intervention / Treatment: Other: Laparoscopic supracervical hysterectomy; Other: Vaginal hysterectomy

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 Prolapse/Urinary 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 10/12mm), two ports (either 5, 8 or 10/12 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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile Ferrando, M.D.; Phone Number: 216-444-0642; Email: ferranc2@ccf.org
• Study Contact Backup: Name: Research Line; Phone Number: 216-445-8090

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Research Line; Phone Number: 216-445-8090
      • Contact: Cecile Ferrando, M.D.; Phone Number: 216-444-0642

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18, who are to undergo laparoscopic sacrocolpopexy for uterovaginal prolapse and desire concurrent hysterectomy at the time of surgery
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures (cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
• Patient's must have an up-to-date PAP smear on record, or a PAP smear is performed in the office and verified to be normal pre-enrollment

Exclusion Criteria:

• Inability to comprehend written and/or spoken English
• Inability to provide informed consent
• Medical illness precluding laparoscopy
• Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
• Sacrocolpoperineopexy
• Patients desiring uterine preservation (hysteropexy)
• Previous apical prolapse surgery (hysteropexy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic supracervical hysterectomy; Minimally invasive procedure to remove a woman's uterus	Other: Laparoscopic supracervical hysterectomy; Laparoscopic supracervical hysterectomy
Experimental: Vaginal hysterectomy; Surgical procedure to remove the uterus	Other: Vaginal hysterectomy; Vaginal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total surgical time - Time of incision to time of sacrocolpopexy completion	Completion = time of abdominal incisions closed	One day intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative mean difference PFDI-20 at 24 months	Mean difference between baseline (pre-operative) and 24 months post-procedure. The Pelvic Floor Disability Index (PFDI-20) is a is a short form that gives a comprehensive assessment of the effect of pelvic floor disorders. The scale exists from 0-4 (0=not present, 4=quite a bit)	24 months
Post-operative mean difference ISI at 24 months	Mean difference between baseline (pre-operative) and 24 months post-procedure. The Incontinence Severity Index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe. The scale exists from 0-12 (0=none, 12=very severe).	24 months
Post-operative mean difference PGII at 24 months	Mean difference between baseline (pre-operative) and 24 months post-procedure. The Patient Global Improvement Indices (PGII) is a seven-item measure which measures symptoms and degree of bother. The scale exists from 0-7 (0=very much better, 7=very much worse).	24 months
Post-operative mean difference PISQ-12 at 24 months	Mean difference between baseline (pre-operative) and 24 months post-procedure. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. The scale exists from 0-4 (0=never, 4=always).	24 months
Postoperative subjective recurrence at 24 months	Subjective recurrence is defined as patients who complain of vaginal bulge sumptoms (Question #3 on the PFDI-20)	24 months
Reported mesh erosion at 24 months	Mesh erosion is defined as presence of eroded mesh in the vagina on examination postoperatively up to 24 months after surgery	24 months
Postoperative objective recurrence at 24 months	Objective recurrence is defined by POP-Q: Apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen	24 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Cecile Ferrando, M.D., The Cleveland Clinic

Publications and helpful links

General Publications

• Nassif J, Yadav GS, Orejuela FJ, Turrentine MA. Rate of Mesh Erosion After Sacrocolpopexy With Concurrent Supracervical Compared With Total Hysterectomy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2022 Sep 1;140(3):412-420. doi: 10.1097/AOG.0000000000004901. Epub 2022 Aug 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-1293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No