Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy

NCT04852991 | Completed DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Operative time

  In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.

• Intra operative blood loss

  During the procedure

• Need for blood transfusion

  During the procedure

• 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

• Duration of post operative hospital stay.

  immediately surgery

Study Arms (2)

Modified Purandare cervicopexy

ACTIVE COMPARATOR

Apical prolapse will be corrected by Modified Purandare cervicopexy

Procedure: Modified Purandare cervicopexy

Abdominal sacrohysterpexy

ACTIVE COMPARATOR

Apical prolapse will be corrected by Abdominal sacrohysterpexy

Procedure: Abdominal sacral hysteropexy

Interventions

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.

Modified Purandare cervicopexy

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

Abdominal sacrohysterpexy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (9)

• 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.

  PMID: 21292234 BACKGROUND

• 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.

  PMID: 27298521 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20966694 BACKGROUND

• 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.

  PMID: 22020436 BACKGROUND

• 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.

  PMID: 22983272 BACKGROUND

• • 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.

  BACKGROUND

• 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.

  PMID: 16934269 BACKGROUND

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

  PMID: 11129939 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed A Nasr Eldeen, MD

  AinShams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 21, 2021
• Study Start: April 15, 2020
• Primary Completion: April 20, 2021
• Study Completion: August 17, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

EG (1)