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Laparoscopic Transabdominal Cerclage: New Approach

NCT02457377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-03-24

No results posted yet for this 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.

Conditions

  • Recurrent Abortion

Interventions

PROCEDURE

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 \&

Sponsors & Collaborators

  • Ahmed Maged

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Kasr Alainy medical school

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457377 on ClinicalTrials.gov