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Completed

NCT Number: NCT04852991

Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AinShams university maternity hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age : 20 years - 40 years
  • BMI: 20 to 35 kg\\m2
  • Any parity with desire for future pregnancy

Exclusion criteria

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

Treatment and study plan

Modified Purandare cervicopexy

Procedure

The modified Purandare's cervicopexy will be performed in low lithotomy position . Pfannenstiel incision was utilized and the abdomen was opened in layers maintaining perfect hemostasis. Uterus will be delivered through the incision and held with uterus holding forceps. The bladder was dissected inferiorly. A 25-30 cm long strip of polypropylene mesh was prepared by soaking. The mesh was fixed anteriorly at the level of isthmus by No.1 polypropylene sutures . The ends of the mesh were brought lateral to rectus muscle retroperitoneally on both sides taking care not to injure the inferior epigastric vessels. After confirming the correct fixation and haemostasis the uterovesical fold of peritoneum was approximated. The ends of the mesh were fixed to the rectus muscle by criss crossing using No. 1 polypropylene sutures. After confirming the haemostasis, the abdomen was closed in layers. Per speculum examination was done to note the reduction of prolapse.

Abdominal sacral hysteropexy

Procedure

After peritoneal entry through pfannenstiel incision was, the bladder is mobilized off the cervix. Windows are made in the broad ligament at the level of the isthmus. Posteriorly, the rectovaginal space is entered at the level of the uterosacral ligaments. Next, a 15x15-cm polypropylene mesh is used to fashion two 4.5- to 5-cm-wide strips of mesh; one is bisected for a distance of 5 cm to produce a Y-configuration for the anterior mesh.The anterior mesh arms are passed through the broad ligament windows and attached to the cervix and pubocervical fascia using interrupted 2-0 PDS. The posterior mesh is attached to the rectovaginal fascia using transverse-interrupted 2-0 PDS sutures. Once the sacral dissection has exposed the anterior longitudinal ligament, the proximal ends of the 2 mesh strips are attached to the sacral promontory using two 2-0 polyester sutures to provide elevation of the uterus without tension. The peritoneum is closed over the mesh using a 3-0 vicryl suture

Primary outcomes

  1. Recurrence

    Time frame: 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 outcomes

  1. Operative time

    Time frame: 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.

  2. Intra operative blood loss

    Time frame: 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
  3. Need for blood transfusion

    Time frame: During the procedure

    number of participants who need blood transfusion

  4. Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)

    Time frame: 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).
  5. Duration of post operative hospital stay.

    Time frame: 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

  6. Bowel injury

    Time frame: During the procedure

    number of participants who suffered from bowel injury during the procedure

  7. Vascular injury

    Time frame: During the procedure

    number of participants who suffered from vascular injury during the procedure

  8. Subfascial hematoma

    Time frame: up to 6 weeks after surgery

    number of participants who will suffer from subfascial hematoma

  9. urinary tract infection

    Time frame: up to 6 weeks after surgery

    number of participants who will suffer from urinary tract infection

  10. Surgical site infection

    Time frame: up to 6 weeks after surgery

    number of participants who will suffer from surgical site infection

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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