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Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified Purandare cervicopexy
Abdominal sacral hysteropexy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 .

Sites / Locations

  • AinShams university maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modified Purandare cervicopexy

Abdominal sacrohysterpexy

Arm Description

Apical prolapse will be corrected by Modified Purandare cervicopexy

Apical prolapse will be corrected by Abdominal sacrohysterpexy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Operative time
Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
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
Need for blood transfusion
number of participants who need blood transfusion
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).
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
Bowel injury
number of participants who suffered from bowel injury during the procedure
Vascular injury
number of participants who suffered from vascular injury during the procedure
Subfascial hematoma
number of participants who will suffer from subfascial hematoma
urinary tract infection
number of participants who will suffer from urinary tract infection
Surgical site infection
number of participants who will suffer from surgical site infection

Full Information

First Posted
March 28, 2021
Last Updated
August 11, 2022
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04852991
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Purandare cervicopexy
Arm Type
Active Comparator
Arm Description
Apical prolapse will be corrected by Modified Purandare cervicopexy
Arm Title
Abdominal sacrohysterpexy
Arm Type
Active Comparator
Arm Description
Apical prolapse will be corrected by Abdominal sacrohysterpexy
Intervention Type
Procedure
Intervention Name(s)
Modified Purandare cervicopexy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Abdominal sacral hysteropexy
Intervention Description
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 Outcome Measure Information:
Title
Recurrence
Description
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.
Time Frame
twelve months after the procedure
Secondary Outcome Measure Information:
Title
Operative time
Description
Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Time Frame
In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Title
Intra operative blood loss
Description
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
Time Frame
During the procedure
Title
Need for blood transfusion
Description
number of participants who need blood transfusion
Time Frame
During the procedure
Title
Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)
Description
- Postoperative pain will be assessed using 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
Title
Duration of post operative hospital stay.
Description
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
Time Frame
immediately surgery
Title
Bowel injury
Description
number of participants who suffered from bowel injury during the procedure
Time Frame
During the procedure
Title
Vascular injury
Description
number of participants who suffered from vascular injury during the procedure
Time Frame
During the procedure
Title
Subfascial hematoma
Description
number of participants who will suffer from subfascial hematoma
Time Frame
up to 6 weeks after surgery
Title
urinary tract infection
Description
number of participants who will suffer from urinary tract infection
Time Frame
up to 6 weeks after surgery
Title
Surgical site infection
Description
number of participants who will suffer from surgical site infection
Time Frame
up to 6 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Nasr Eldeen, MD
Organizational Affiliation
AinShams university
Official's Role
Study Director
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
21292234
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.
Results Reference
background
PubMed Identifier
27298521
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
20966694
Citation
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.
Results Reference
background
PubMed Identifier
22020436
Citation
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.
Results Reference
background
PubMed Identifier
22983272
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.
Results Reference
background
Citation
• 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.
Results Reference
background
PubMed Identifier
16934269
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. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.
Results Reference
background
PubMed Identifier
11129939
Citation
Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
Results Reference
background

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Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

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