Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy.

NCT04856709 | Completed

• 1 other identifier: Pectopexy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare between abdominal pectopexy and abdominal sacral hysteropexy in terms of efficacy (assessed by POP-Q system), intra and postoperative complications.

Conditions

Genital Prolapse

Outcome Measures

Primary Outcomes (1)

• Efficacy, After the procedure there will be follow up visits at 3 months to detect the efficacy of the procedure by using POP-Q system.

  The POP-Q system is a technique that measures compartment prolapse relative to the anatomic landmark of the hymen.Prolapse points proximal to the hymen are given a negative value, whereas positive values are given to points that protrude past the hymen. 6 points are delineated, including two on the anterior vaginal wall (Aa, Ba), two on the vaginal apex (C, D), and two on the posterior vaginal wall (Ap, Bp). Points Gh, Pb, and TVL describe the genital hiatus, perineal body, and total vaginal length, respectively. * Stage 0: no demonstrable prolapse * Stage 1: the most distal portion of the prolapsed segment is \>1 cm above the level of the hymen * Stage 2: the most distal portion of the prolapsed segment is \>1 cm or less proximal or distal to the hymen * Stage 3: the most distal portion of the prolapsed segment protrudes \>1 cm below the hymen but 2 cm less than the total length of the vagina * Stage 4: complete eversion of the vagina

  3 months

Secondary Outcomes (5)

• Operative time

  60- 240 minutes

• Intra operative blood loss

  60- 240 minutes

• Intra operative complications

  60- 240 minutes

• Post operative complications

  1 week

• Post operative pain

  after 6 hours, 12 hours and 24 hours from the operation

Study Arms (1)

study group

OTHER

Women with stage 2 to 4 uterine prolapse. BMI from ≤ 35 kg\\m2. Women of any parity including nulliparas will be included. Age of female patients ranges from 20 to 40 years.

Procedure: Abdominal Pectopexy; Procedure: Abdominal Sacral Hysteropexy

Interventions

Abdominal Pectopexy PROCEDURE

Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension.

study group

Abdominal Sacral Hysteropexy PROCEDURE

Abdominal sacrocolpopexy is a procedure that uses a mesh material to support the top of the vagina to treat pelvic prolapse.

study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with stage 2 to 4 uterine prolapse.
• BMI from ≤ 35 kg\\m2.
• Women of any parity including nulliparas will be included.
• Age of female patients ranges from 20 to 40 years.

You may not qualify if:

• Previous correction of apical prolapse.
• Inoperable co-existing uterine pathology

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Study design: Randomized Controlled clinical Trial * Study Setting: Ain Shams maternity hospital. * Study Population: The study included 80 women divided into 2 groups: Group A: 40 women underwent abdominal pectopexy. Group B: 40 women underwent abdominal sacral hysteropexy.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 23, 2021
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: April 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publication

Locations

EG (1)