Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Modified Purandare cervicopexy; Procedure: Abdominal sacral hysteropexy

• Registration Number: NCT04852991
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

This study aims to compare safety, efficacy and complications of modified Purandare's cervicopexy with abdominal sacral hysteropexy as conservative surgery in the treatment of genital prolapse in reproductive age group patients at Ain Shams Maternity hospital.

Detailed 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. Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse . 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 .

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% . 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.

The core of the modified purandare's cervicopexy is fixation of the uterine isthmus by a 25-30 cm long strip of polypropylene mesh to the rectus muscle by criss crossing using No. 1 polypropylene sutures.

Modified purandare's cervicopexy is easy to perform and provides dynamic support to the uterus, improves fertility, doesn't interfere with vaginal birth and if caesarean delivery is required doesn't damage the mesh thus reducing the recurrence of prolapse and has many advantages compared to the original operation which can favourably affect the outcome, such as: criss crossing of mesh on rectus muscle which provides a space for low transverse incision for caesarean section without compromising the mesh anchoring and retaining the support. This surgery is technically easy to perform and complications like Periosteitis, ureteric and sigmoid injuries are avoided.

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.

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2021-03-28
• Primary Completion: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Study Completion: 2021-08-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Age : 20 years - 40 years
2. BMI: 20 to 35 kg\m2
3. Any parity with desire for future pregnancy

Exclusion Criteria

1. 1st degree uterine prolapse.
2. Previous correction of apical prolapse.
3. Co-existing uterine pathology e.g. uterine fibroid .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Purandare cervicopexy	Modified Purandare cervicopexy	Apical prolapse will be corrected by Modified Purandare cervicopexy
Abdominal sacrohysterpexy	Abdominal sacral hysteropexy	Apical prolapse will be corrected by Abdominal sacrohysterpexy

Primary Outcome Measures

Name	Time	Method
Recurrence	twelve months after the procedure	After the procedure there will be follow up visits at 12 months respectively to detect if there is recurrence or not by history taking and pelvic examination.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)	This will be assessed after 6 hours, 12 hours and 24 hours from the operation	- Postoperative pain will be assessed using the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain).
Vascular injury	During the procedure	number of participants who suffered from vascular injury during the procedure
urinary tract infection	up to 6 weeks after surgery	number of participants who will suffer from urinary tract infection
Surgical site infection	up to 6 weeks after surgery	number of participants who will suffer from surgical site infection
Operative time	In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.	Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Need for blood transfusion	During the procedure	number of participants who need blood transfusion
Duration of post operative hospital stay.	immediately surgery	Duration of postoperative hospital stay will be measured from the end of the procedure till discharge from hospital and it will be measured in hours
Bowel injury	During the procedure	number of participants who suffered from bowel injury during the procedure
Intra operative blood loss	During the procedure	Intraoperative blood loss will be estimated via: * Amount of blood in suction bottle.; * Estimation based on the number of soaked gauzes by weighing the gauzes used in the procedure before and after surgery ( each 1 mg f corresponds to 1 ml of blood); * Drop in postoperative hemoglobin and hematocrit when compared with preoperative values
Subfascial hematoma	up to 6 weeks after surgery	number of participants who will suffer from subfascial hematoma

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Egypt