Clinical trial NCT04852991: Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy
Official title: Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Recurrence
timeFrame: twelve months after the procedure
Secondary outcomes:
measure: Operative time
timeFrame: In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
measure: Intra operative blood loss
timeFrame: During the procedure
measure: Need for blood transfusion
timeFrame: During the procedure
measure: Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)
timeFrame: This will be assessed after 6 hours, 12 hours and 24 hours from the operation
measure: Duration of post operative hospital stay.
timeFrame: immediately surgery
measure: Bowel injury
timeFrame: During the procedure
measure: Vascular injury
timeFrame: During the procedure
measure: Subfascial hematoma
timeFrame: up to 6 weeks after surgery
measure: urinary tract infection
timeFrame: up to 6 weeks after surgery
measure: Surgical site infection
timeFrame: up to 6 weeks after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
Study officials:
affiliation: AinShams university
name: Mohammed A Nasr Eldeen, MD
role: STUDY_DIRECTOR
References:
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citation: R., Rameshkumar & Kamat, Leena & Tungal, Spoorthi & Moni, Suma. (2017). Modified purandare's cervicopexy-a conservative surgery for genital prolapse: a retrospective study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology. 6. 10.18203/2320-1770.ijrcog20171529.
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