Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852991
• Other study ID #: 4
• Status: Completed
• Phase: N/A
• Start date: April 15, 2020
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2022
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 17, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Modified Purandare cervicopexy
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
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

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

• Cvach, K. and Cundiff, G. Abdominal Sacral Hysteropexy: Clinical Outcomes Compared to Abdominal Sacral Colpopexy With Concurrent Hysterectomy. Univers. British Columbia (UBC), 2008, 677-678.

Cvach K, Dwyer P. Surgical management of pelvic organ prolapse: abdominal and vaginal approaches. World J Urol. 2012 Aug;30(4):471-7. doi: 10.1007/s00345-011-0776-y. Epub 2011 Oct 22. Review. — View Citation

Cvach K, Geoffrion R, Cundiff GW. Abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy. Female Pelvic Med Reconstr Surg. 2012 Sep-Oct;18(5):286-90. doi: 10.1097/SPV.0b013e3182673772. — View Citation

Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7. — View Citation

Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. Epub 2006 Aug 23. — View Citation

Lowder JL, Ghetti C, Nikolajski C, Oliphant SS, Zyczynski HM. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol. 2011 May;204(5):441.e1-5. doi: 10.1016/j.ajog.2010.12.024. Epub 2011 Feb 2. — View 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.

Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729. — View Citation

Virkud A. Conservative Operations in Genital Prolapse. J Obstet Gynaecol India. 2016 Jun;66(3):144-8. doi: 10.1007/s13224-016-0909-8. Epub 2016 Apr 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	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.	twelve months after the procedure
Secondary	Operative time	Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.	In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Secondary	Intra operative blood loss	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	During the procedure
Secondary	Need for blood transfusion	number of participants who need blood transfusion	During the procedure
Secondary	Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)	- Postoperative pain will be assessed using 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
Secondary	Duration of post operative hospital stay.	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	immediately surgery
Secondary	Bowel injury	number of participants who suffered from bowel injury during the procedure	During the procedure
Secondary	Vascular injury	number of participants who suffered from vascular injury during the procedure	During the procedure
Secondary	Subfascial hematoma	number of participants who will suffer from subfascial hematoma	up to 6 weeks after surgery
Secondary	urinary tract infection	number of participants who will suffer from urinary tract infection	up to 6 weeks after surgery
Secondary	Surgical site infection	number of participants who will suffer from surgical site infection	up to 6 weeks after surgery