Laparoscopic Transabdominal Cerclage: New Approach

NCT02457377 | Completed DMC

• 1 other identifier: 136
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

recurrent abortion; cerclage; laparoscopy; cervical imcompetence

Outcome Measures

Primary Outcomes (1)

• completing pregnancy

  number of participants with completing pregnancy

  36 weeks of gestation

Study Arms (1)

Laparoscopic cerclage

EXPERIMENTAL

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

laparoscopic cerclage PROCEDURE

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 \&

Laparoscopic cerclage

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Failed vaginal cerclage 2 successive spontaneous mid trimesteric abortion

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed Maged: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2004
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

EG (1)