Laparoscopic Tubal Preservation Surgery

Ectopic Pregnancy Clinical Trial

Official title:

Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253588
• Other study ID #: 106002-E
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: October 15, 2017

Study information

• Verified date: July 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.

Description:

All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion Criteria:

• women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Procedure:
• laparoscopic salpingotomy or salpingostomy
A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri- and post-operative parameters	success rate of tubal preservation surgery (defined by postoperative serum bcg <5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention)	between January 2009 and November 2016
Secondary	factors affecting the surgical success rate	relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)	between January 2009 and November 2016