Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy.

Genital Prolapse Clinical Trial

Official title:

Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856709
• Other study ID #: Pectopexy
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality (Lowder et al., 2011). Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse (Virkud, 2016). The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits (Rameshkumar et al., 2017). Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% (Olsen et al., 1997; Smith et al., 2010). In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made (Cvach and Dwyer, 2012). Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension. This new method is considered a simple, safe procedure, especially in patients whose surgical exploration is difficult (Banerjee and Noé, 2011). This method uses the iliopectineal ligament on both sides for the mesh fixation, (Banerjee and Noé, 2011). so there is no restriction caused by the mesh. The mesh follows natural structures (round and broad ligaments) without crossing sensitive spots, such as the ureter or bowel. The hypogastric trunk is at a safe distance and out of danger. The iliopectineal ligament is an extension of the lacunar ligament that runs on the pectineal line of the pubic bone (Faure et al., 2001), and is significantly stronger than the sacrospinous ligament and the arcus tendineus of the pelvic fascia (Cosson et al., 2003). The structure is strong, and holds suture well Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment (Cvach and Cundiff, 2008). Although sacrocolpopexy has been the most effective option over time, the procedure is still associated with some problems, and the most frequently reported complications include defecation disorders and stress urinary incontinence (SUI)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse

Intervention

Procedure:
• Abdominal Pectopexy
Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension.
• Abdominal Sacral Hysteropexy
Abdominal sacrocolpopexy is a procedure that uses a mesh material to support the top of the vagina to treat pelvic prolapse.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.	60- 240 minutes
Secondary	Intra operative blood loss	Intra operative blood loss will be estimated via: Amount of blood in suction bottle. Drop in postoperative hemoglobin and hematocrit when compared with preoperative values	60- 240 minutes
Secondary	Intra operative complications	Intra operative complications including: Need for blood transfusion.; Bowel or bladder injury.	60- 240 minutes
Secondary	Post operative complications	Subfascial hematoma or pelvic hematoma.; Surgical site infection.; Urinary tract infection.; Need for post-operative blood transfusion.; Postoperative bowel or urinary tract complications	1 week
Secondary	Post operative pain	Postoperative pain will be assessed using the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain).	after 6 hours, 12 hours and 24 hours from the operation