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CompletedNCT02457377Updated Mar 24, 2017

Laparoscopic Transabdominal Cerclage: New Approach

An interventional study of laparoscopic cerclage in Recurrent Abortion, sponsored by Ahmed Maged. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Ahmed Maged · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 41 Years
Sex
Female
01

Study summary

A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening the curvature of the needles, while introducing the tape into the abdomen, will eventually pose a challenge during placement of the stitch (the needles' curvatures guarantee that the tissue penetration is done away from the uterine vessels).

To overcome this problem, the following method was devised. A one cm suprapubic incision is made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A grasper from one of the flank ports receives the tip and the needle is delivered carefully (FIGURE 1). The rest of the tape is pulled until the blunt end of the other needle appears, to be delivered in the same way but in the reverse order.

  • Operative Steps The vesico-uterine peritoneum is opened using scissors \& the urinary bladder is dissected downwards from the lower uterine segment to expose the uterine vessels anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right \& left sides (from anterior to posterior) . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right \& left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots \& the ends of the stitch are trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage with a running (00) Monocryl suture that is tied intracorporeally.
Read the detailed description

Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position. The patient is then prepped and draped in the usual fashion for an abdominal \& vaginal procedure. A vaginal speculum is inserted into the vagina to expose both the cervix and posterior fornix. A uterine manipulator is inserted in the uterus in non-pregnant patients, followed by placement of a Foley's catheter in the bladder. As regards port placement, a 10-mm umbilical trocar \& two 5-mm trocars in right \& left lower quadrants are inserted.

  • Introduction of Mersilene Tape into the Abdominal Cavity: A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening the curvature of the needles, while introducing the tape into the abdomen, will eventually pose a challenge during placement of the stitch (the needles' curvatures guarantee that the tissue penetration is done away from the uterine vessels).

To overcome this problem, the following method was devised. A one cm suprapubic incision is made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A grasper from one of the flank ports receives the tip and the needle is delivered carefully . The rest of the tape is pulled until the blunt end of the other needle appears, to be delivered in the same way but in the reverse order.

  • Operative Steps The vesico-uterine peritoneum is opened using scissors \& the urinary bladder is dissected downwards from the lower uterine segment to expose the uterine vessels anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right \& left sides (from anterior to posterior) Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right \& left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots \& the ends of the stitch are trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage with a running (00) Monocryl suture that is tied intracorporeally.
02

Conditions studied

  • Recurrent Abortion

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Keywords

  • recurrent abortion
  • cerclage
  • laparoscopy
  • cervical imcompetence
03

In context

Abortion, Habitual

138 studies on the registry are indexed under Abortion, Habitual; 23 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 74 interventional studies indexed under Abortion, Habitual.

Browse Abortion, Habitual studies →

Lead sponsor

Ahmed Maged is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 41 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Failed vaginal cerclage 2 successive spontaneous mid trimesteric abortion

Exclusion criteria

Exclusion Criteria:

  • rupture of membranes Uterine contractions evidence of intraamniotic infections contraindications to laparoscopy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Laparoscopic cerclage

    The vesico-uterine peritoneum is opened \& the urinary bladder is dissected downwards . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right \& left sides . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right \& left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots \&

    Procedure: laparoscopic cerclage

Interventions

  • Procedurelaparoscopic cerclage

    The vesico-uterine peritoneum is opened \& the urinary bladder is dissected downwards . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right \& left sides . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right \& left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots \&

06

What researchers measure

Primary outcomes

  1. completing pregnancy

    number of participants with completing pregnancy

    Time frame: 36 weeks of gestation

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, Cairo Governorate 12151, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02457377
Lead sponsor
Ahmed Maged
Responsible party
Ahmed Maged (Assistant professor, Cairo University) — Sponsor-investigator
First posted
May 29, 2015
Start date
Jan 2004
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Mar 24, 2017

Study contacts

Ahmed Maged, MD
principal investigator · Kasr Alainy medical school

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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